Trial Outcomes & Findings for Apneic Oxygenation During Airway Management in Pediatric Patients (NCT NCT02437864)
NCT ID: NCT02437864
Last Updated: 2018-09-17
Results Overview
Prior to anesthesia induction, patients are ventilated to achieve pulse oximetry (SpO2) values near 100%. This outcome represents the elapsed time before successful intubation or pulse oximetry declining to 95%, whichever came first.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
360 participants
Primary outcome timeframe
From anesthetic induction to whichever comes first: pulse oximetry falling to 95%, or successful intubation; an expected average of less than 10 minutes
Results posted on
2018-09-17
Participant Flow
Participant milestones
| Measure |
Baseline Group
Airway management (intubation) undertaken immediately after anesthetic induction, without simultaneous supplemental oxygen via nasal cannula.
|
With-Cannula Group
Airway management (intubation) undertaken immediately after anesthetic induction, with simultaneous supplemental oxygen via nasal cannula.
Supplemental oxygen via nasal cannula
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
160
|
|
Overall Study
COMPLETED
|
196
|
160
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Baseline Group
Airway management (intubation) undertaken immediately after anesthetic induction, without simultaneous supplemental oxygen via nasal cannula.
|
With-Cannula Group
Airway management (intubation) undertaken immediately after anesthetic induction, with simultaneous supplemental oxygen via nasal cannula.
Supplemental oxygen via nasal cannula
|
|---|---|---|
|
Overall Study
Protocol Violation
|
4
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Baseline Group
n=196 Participants
Airway management (intubation) undertaken immediately after anesthetic induction, without simultaneous supplemental oxygen via nasal cannula.
|
With-Cannula Group
n=160 Participants
Airway management (intubation) undertaken immediately after anesthetic induction, with simultaneous supplemental oxygen via nasal cannula.
Supplemental oxygen via nasal cannula
|
Total
n=356 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
196 Participants
n=196 Participants
|
160 Participants
n=160 Participants
|
356 Participants
n=356 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=196 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=356 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=196 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=356 Participants
|
|
Age, Continuous
|
3 years
n=196 Participants
|
2 years
n=160 Participants
|
3 years
n=356 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=196 Participants
|
67 Participants
n=160 Participants
|
154 Participants
n=356 Participants
|
|
Sex: Female, Male
Male
|
109 Participants
n=196 Participants
|
93 Participants
n=160 Participants
|
202 Participants
n=356 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
196 participants
n=196 Participants
|
160 participants
n=160 Participants
|
356 participants
n=356 Participants
|
|
Weight
|
13.9 kilograms
n=196 Participants
|
13.4 kilograms
n=160 Participants
|
13.6 kilograms
n=356 Participants
|
|
Height
|
95.3 centimeters
n=196 Participants
|
89.3 centimeters
n=160 Participants
|
92.5 centimeters
n=356 Participants
|
|
Body Mass Index (BMI)
|
16.6 kg/m^2
n=196 Participants
|
16.3 kg/m^2
n=160 Participants
|
16.4 kg/m^2
n=356 Participants
|
PRIMARY outcome
Timeframe: From anesthetic induction to whichever comes first: pulse oximetry falling to 95%, or successful intubation; an expected average of less than 10 minutesPrior to anesthesia induction, patients are ventilated to achieve pulse oximetry (SpO2) values near 100%. This outcome represents the elapsed time before successful intubation or pulse oximetry declining to 95%, whichever came first.
Outcome measures
| Measure |
Baseline Group
n=196 Participants
Airway management (intubation) undertaken immediately after anesthetic induction, without simultaneous supplemental oxygen via nasal cannula.
|
With-Cannula Group
n=160 Participants
Airway management (intubation) undertaken immediately after anesthetic induction, with simultaneous supplemental oxygen via nasal cannula.
Supplemental oxygen via nasal cannula
|
|---|---|---|
|
Time to First Event: Pulse Oximetry at 95%, or Successful Intubation
|
106 seconds
Interval 75.0 to 147.0
|
169 seconds
Interval 128.0 to 225.0
|
SECONDARY outcome
Timeframe: From anesthetic induction to intubation; an expected average of 10 minutesOutcome measures
| Measure |
Baseline Group
n=196 Participants
Airway management (intubation) undertaken immediately after anesthetic induction, without simultaneous supplemental oxygen via nasal cannula.
|
With-Cannula Group
n=160 Participants
Airway management (intubation) undertaken immediately after anesthetic induction, with simultaneous supplemental oxygen via nasal cannula.
Supplemental oxygen via nasal cannula
|
|---|---|---|
|
Number of Patients Whose Pulse Oximetry Falls Below 95% During Airway Placement
|
85 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: From anesthetic induction to intubation; an expected average of 10 minutesOutcome measures
| Measure |
Baseline Group
n=196 Participants
Airway management (intubation) undertaken immediately after anesthetic induction, without simultaneous supplemental oxygen via nasal cannula.
|
With-Cannula Group
n=160 Participants
Airway management (intubation) undertaken immediately after anesthetic induction, with simultaneous supplemental oxygen via nasal cannula.
Supplemental oxygen via nasal cannula
|
|---|---|---|
|
Number of Patients Requiring Intervention by Attending or Temporary Mask Ventilation During Airway Placement
|
52 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: From anesthetic induction to intubation; an expected average of 10 minutesOutcome measures
| Measure |
Baseline Group
n=196 Participants
Airway management (intubation) undertaken immediately after anesthetic induction, without simultaneous supplemental oxygen via nasal cannula.
|
With-Cannula Group
n=160 Participants
Airway management (intubation) undertaken immediately after anesthetic induction, with simultaneous supplemental oxygen via nasal cannula.
Supplemental oxygen via nasal cannula
|
|---|---|---|
|
Number of Patients Whose Pulse Oximetry Falls Below 90% During Airway Placement
|
61 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From anesthetic induction to intubation; an expected average of 10 minutesOutcome measures
| Measure |
Baseline Group
n=196 Participants
Airway management (intubation) undertaken immediately after anesthetic induction, without simultaneous supplemental oxygen via nasal cannula.
|
With-Cannula Group
n=160 Participants
Airway management (intubation) undertaken immediately after anesthetic induction, with simultaneous supplemental oxygen via nasal cannula.
Supplemental oxygen via nasal cannula
|
|---|---|---|
|
Patients' Lowest Pulse Oximetry Value Observed During Airway Placement
|
97 percentage of oxygenated hemoglobin
Interval 89.0 to 99.0
|
99 percentage of oxygenated hemoglobin
Interval 98.0 to 100.0
|
Adverse Events
Baseline Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
With-Cannula Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Codruta Soneru
University of New Mexico Health Sciences Center (HSC)
Phone: 5052722610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place