Trial Outcomes & Findings for Pragmatic Trial Examining Oxygenation Prior to Intubation (NCT NCT05267652)
NCT ID: NCT05267652
Last Updated: 2024-12-09
Results Overview
A peripheral oxygen saturation \< 85% during the interval between induction and 2 minutes after tracheal intubation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1301 participants
Primary outcome timeframe
from induction to 2 minutes following tracheal intubation
Results posted on
2024-12-09
Participant Flow
Participant milestones
| Measure |
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
|
Preoxygenation With Facemask Oxygen Group
For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
|
|---|---|---|
|
Overall Study
STARTED
|
645
|
656
|
|
Overall Study
COMPLETED
|
645
|
656
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pragmatic Trial Examining Oxygenation Prior to Intubation
Baseline characteristics by cohort
| Measure |
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
n=645 Participants
Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
|
Preoxygenation With Facemask Oxygen Group
n=656 Participants
For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
|
Total
n=1301 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Region of Enrollment
United States
|
645 participants
n=5 Participants
|
656 participants
n=7 Participants
|
1301 participants
n=5 Participants
|
|
Age, Continuous
|
61 years
n=5 Participants
|
61 years
n=7 Participants
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
255 Participants
n=5 Participants
|
260 Participants
n=7 Participants
|
515 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
390 Participants
n=5 Participants
|
396 Participants
n=7 Participants
|
786 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
384 Participants
n=5 Participants
|
399 Participants
n=7 Participants
|
783 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
124 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
276 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
80 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
48 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from induction to 2 minutes following tracheal intubationA peripheral oxygen saturation \< 85% during the interval between induction and 2 minutes after tracheal intubation
Outcome measures
| Measure |
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
n=624 Participants
Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
|
Preoxygenation With Facemask Oxygen Group
n=637 Participants
For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
|
|---|---|---|
|
Incidence of Hypoxemia
|
57 Participants
|
118 Participants
|
SECONDARY outcome
Timeframe: from induction to 2 minutes following tracheal intubationLowest oxygen saturation during the interval between induction and 2 minutes after tracheal intubation
Outcome measures
| Measure |
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
n=624 Participants
Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
|
Preoxygenation With Facemask Oxygen Group
n=637 Participants
For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
|
|---|---|---|
|
Lowest Oxygen Saturation
|
99 Oxygen Saturation (%)
Interval 95.0 to 100.0
|
97 Oxygen Saturation (%)
Interval 89.0 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from induction to 2 minutes following tracheal intubationOutcome measures
| Measure |
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
n=645 Participants
Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
|
Preoxygenation With Facemask Oxygen Group
n=656 Participants
For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
|
|---|---|---|
|
Incidence of Operator-reported Aspiration
|
6 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hours after inductionOutcome measures
| Measure |
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
n=590 Participants
Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
|
Preoxygenation With Facemask Oxygen Group
n=594 Participants
For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
|
|---|---|---|
|
Fraction of Inspired Oxygen at 24 Hours After Induction
|
40 Percentage
Interval 30.0 to 40.0
|
40 Percentage
Interval 30.0 to 40.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hours after inductionOutcome measures
| Measure |
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
n=589 Participants
Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
|
Preoxygenation With Facemask Oxygen Group
n=594 Participants
For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
|
|---|---|---|
|
Oxygen Saturation at 24 Hours After Induction
|
97 Oxygen Saturation (%)
Interval 95.0 to 100.0
|
97 Oxygen Saturation (%)
Interval 95.0 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from induction to 24 hours after inductionRadiology report of new pneumothorax on chest x-ray in the 24 hours after induction
Outcome measures
| Measure |
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
n=509 Participants
Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
|
Preoxygenation With Facemask Oxygen Group
n=497 Participants
For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
|
|---|---|---|
|
Incidence of Pneumothorax
|
7 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from induction to 24 hours after inductionRadiology report of new infiltrate on chest imaging in the 24 hours after intubation
Outcome measures
| Measure |
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
n=509 Participants
Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
|
Preoxygenation With Facemask Oxygen Group
n=497 Participants
For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
|
|---|---|---|
|
Incidence of New Infiltrate
|
144 Participants
|
148 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from induction to 2 minutes following tracheal intubationLowest oxygen saturation of \<80% between induction and two minutes after tracheal intubation
Outcome measures
| Measure |
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
n=624 Participants
Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
|
Preoxygenation With Facemask Oxygen Group
n=637 Participants
For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
|
|---|---|---|
|
Incidence of Severe Hypoxemia
|
39 Participants
|
84 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from induction to 2 minutes following tracheal intubationLowest oxygen saturation of \<70% between induction and two minutes after tracheal intubation
Outcome measures
| Measure |
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
n=624 Participants
Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
|
Preoxygenation With Facemask Oxygen Group
n=637 Participants
For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
|
|---|---|---|
|
Incidence of Very Severe Hypoxemia
|
15 Participants
|
36 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from enrollment to inductionOutcome measures
| Measure |
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
n=625 Participants
Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
|
Preoxygenation With Facemask Oxygen Group
n=643 Participants
For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
|
|---|---|---|
|
Oxygen Saturation at Induction
|
100 Oxygen Saturation (%)
Interval 99.0 to 100.0
|
100 Oxygen Saturation (%)
Interval 97.0 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from enrollment to inductionOutcome measures
| Measure |
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
n=619 Participants
Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
|
Preoxygenation With Facemask Oxygen Group
n=632 Participants
For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
|
|---|---|---|
|
Systolic Blood Pressure at Induction
|
124 mmHg
Interval 107.0 to 143.0
|
129 mmHg
Interval 111.0 to 148.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Duration of procedure (minutes)Outcome measures
| Measure |
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
n=645 Participants
Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
|
Preoxygenation With Facemask Oxygen Group
n=656 Participants
For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
|
|---|---|---|
|
Duration From Induction to Successful Intubation
|
115 Seconds
Interval 89.0 to 150.0
|
113 Seconds
Interval 85.0 to 152.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Duration of procedure (minutes)Grade 1: Full view of glottis Grade 2: Partial view of glottis Grade 3: Only epiglottis seen (none of glottis) Grade 4: Neither glottis nor epiglottis seen
Outcome measures
| Measure |
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
n=645 Participants
Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
|
Preoxygenation With Facemask Oxygen Group
n=655 Participants
For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
|
|---|---|---|
|
Cormack-Lehane Grade of Glottic View on First Attempt
Grade 1
|
434 Participants
|
456 Participants
|
|
Cormack-Lehane Grade of Glottic View on First Attempt
Grade 2
|
165 Participants
|
148 Participants
|
|
Cormack-Lehane Grade of Glottic View on First Attempt
Grade 3
|
29 Participants
|
36 Participants
|
|
Cormack-Lehane Grade of Glottic View on First Attempt
Grade 4
|
17 Participants
|
15 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Duration of procedure (minutes)Placement of an endotracheal tube in the trachea with a single insertion of a laryngoscope blade into the mouth and either a single insertion of an endotracheal tube into the mouth or a single insertion of a bougie into the mouth followed by a single insertion of an endotracheal tube into the mouth
Outcome measures
| Measure |
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
n=645 Participants
Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
|
Preoxygenation With Facemask Oxygen Group
n=656 Participants
For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
|
|---|---|---|
|
Incidence of Successful Intubation on the First Attempt
|
534 Participants
|
535 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Duration of procedure (minutes)Outcome measures
| Measure |
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
n=641 Participants
Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
|
Preoxygenation With Facemask Oxygen Group
n=654 Participants
For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
|
|---|---|---|
|
Number of Laryngoscopy Attempts
|
1 attempts
Interval 1.0 to 1.0
|
1 attempts
Interval 1.0 to 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Duration of procedure (minutes)Outcome measures
| Measure |
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
n=641 Participants
Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
|
Preoxygenation With Facemask Oxygen Group
n=655 Participants
For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
|
|---|---|---|
|
Number of Attempts at Passing a Bougie
|
0 attempts
Interval 0.0 to 1.0
|
0 attempts
Interval 0.0 to 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Duration of procedure (minutes)Outcome measures
| Measure |
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
n=641 Participants
Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
|
Preoxygenation With Facemask Oxygen Group
n=654 Participants
For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
|
|---|---|---|
|
Number of Attempts at Passing an Endotracheal Tube
|
1 attempts
Interval 1.0 to 1.0
|
1 attempts
Interval 1.0 to 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from induction to 2 minutes following tracheal intubationA composite of one or more of the following between induction and 2 minutes after intubation: * Systolic blood pressure \< 65 mmHg * New or increased vasopressor * Cardiac arrest not resulting in death within 1 hour of induction * Cardiac arrest resulting in death within 1 hour of induction
Outcome measures
| Measure |
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
n=645 Participants
Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
|
Preoxygenation With Facemask Oxygen Group
n=656 Participants
For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
|
|---|---|---|
|
Incidence of Cardiovascular Collapse
|
113 Participants
|
127 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 daysOutcome measures
| Measure |
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
n=645 Participants
Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
|
Preoxygenation With Facemask Oxygen Group
n=656 Participants
For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
|
|---|---|---|
|
28-day In-hospital Mortality
|
209 Participants
|
217 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 daysOutcome measures
| Measure |
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
n=645 Participants
Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
|
Preoxygenation With Facemask Oxygen Group
n=656 Participants
For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
|
|---|---|---|
|
Ventilator-free Days to 28 Days
|
21 Days
Interval 0.0 to 26.0
|
17 Days
Interval 0.0 to 25.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 daysOutcome measures
| Measure |
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
n=645 Participants
Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
|
Preoxygenation With Facemask Oxygen Group
n=656 Participants
For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
|
|---|---|---|
|
ICU-free Days to 28 Days
|
16 Days
Interval 0.0 to 23.0
|
14 Days
Interval 0.0 to 23.0
|
Adverse Events
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
Serious events: 2 serious events
Other events: 0 other events
Deaths: 209 deaths
Preoxygenation With Facemask Oxygen Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 217 deaths
Serious adverse events
| Measure |
Preoxygenation With Non-Invasive Positive Pressure Ventilation Group
n=645 participants at risk
Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
|
Preoxygenation With Facemask Oxygen Group
n=656 participants at risk
For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
|
|---|---|---|
|
Surgical and medical procedures
Aspiration
|
0.31%
2/645 • Number of events 2 • Adverse events were collected from enrollment to 28 days after enrollment.
Because this trial compared strategies commonly used in routine clinical care, the only events that were recorded or reported as adverse events were those that were related to the study and serious or unexpected. Critically ill adults who require tracheal intubation are at risk for hypoxemia, hypotension, cardiac arrest, and death. These events were recorded as study outcomes and only recorded as AEs if related to the study intervention, which was expected to be rare.
|
0.00%
0/656 • Adverse events were collected from enrollment to 28 days after enrollment.
Because this trial compared strategies commonly used in routine clinical care, the only events that were recorded or reported as adverse events were those that were related to the study and serious or unexpected. Critically ill adults who require tracheal intubation are at risk for hypoxemia, hypotension, cardiac arrest, and death. These events were recorded as study outcomes and only recorded as AEs if related to the study intervention, which was expected to be rare.
|
Other adverse events
Adverse event data not reported
Additional Information
Jonathan D Casey, MD, MSc
Vanderbilt University Medical Center
Phone: 615-875-4681
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place