Trial Outcomes & Findings for Adjunctive Nitrous Oxide During Emergency Department Propofol Sedation in Adults (NCT NCT02410707)
NCT ID: NCT02410707
Last Updated: 2020-04-08
Results Overview
End tidal CO2 and SpO2 measured every 20 milliseconds seconds captured by a monitoring device. Events of respiratory depression are defined as peripheral SaO2 below 92%, ETCO2 level above 50, a rise or decrease of 10% above or below baseline, and/or the loss of the ETCO2 waveform for more than 15 seconds
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
day 1
Results posted on
2020-04-08
Participant Flow
Participant milestones
| Measure |
Nitrous Oxide Arm
Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.
Nitrous Oxide arm: Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.
Propofol: The loading dose of propofol will be administered immediately after nitrous oxide use
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|---|---|
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Overall Study
STARTED
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43
|
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Overall Study
COMPLETED
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43
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adjunctive Nitrous Oxide During Emergency Department Propofol Sedation in Adults
Baseline characteristics by cohort
| Measure |
Nitrous Oxide Arm
n=43 Participants
Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.
Nitrous Oxide arm: Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.
Propofol: The loading dose of propofol will be administered immediately after nitrous oxide use
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|---|---|
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Age, Continuous
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46.33 years
STANDARD_DEVIATION 20.2 • n=5 Participants
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Sex: Female, Male
Female
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16 Participants
n=5 Participants
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Sex: Female, Male
Male
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27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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22 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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11 Participants
n=5 Participants
|
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Region of Enrollment
United States
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43 participants
n=5 Participants
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Fracture/Reduction
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41 Participants
n=5 Participants
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Baseline VAS Pain Score
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76.29 units on a scale
STANDARD_DEVIATION 26.33 • n=5 Participants
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PRIMARY outcome
Timeframe: day 1End tidal CO2 and SpO2 measured every 20 milliseconds seconds captured by a monitoring device. Events of respiratory depression are defined as peripheral SaO2 below 92%, ETCO2 level above 50, a rise or decrease of 10% above or below baseline, and/or the loss of the ETCO2 waveform for more than 15 seconds
Outcome measures
| Measure |
Nitrous Oxide Arm
n=43 Participants
Nitrous Oxide arm: Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.
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|---|---|
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Total Number of Respiratory Depression Events
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0 events
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SECONDARY outcome
Timeframe: day 1Presence or absence of physician intervention requiring airway repositioning by provider due to decreased oxygen saturation less than 92%
Outcome measures
| Measure |
Nitrous Oxide Arm
n=43 Participants
Nitrous Oxide arm: Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.
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|---|---|
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Total Number of Airway Repositioning Events
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0 events of airway repositioning
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SECONDARY outcome
Timeframe: day 1Presence or absence of physician intervention requiring additional oxygen via nasal cannula or non rebreather by the provider due to oxygen saturation less than 92%
Outcome measures
| Measure |
Nitrous Oxide Arm
n=43 Participants
Nitrous Oxide arm: Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.
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|---|---|
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Total Number of Events Requiring Additional Oxygen
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0 events of additional oxygen
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SECONDARY outcome
Timeframe: day 1Presence or absence of physician intervention requiring positive pressure ventilation via a bag valve max due to decreased oxygen saturation less than 92%
Outcome measures
| Measure |
Nitrous Oxide Arm
n=43 Participants
Nitrous Oxide arm: Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.
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|---|---|
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Total Number of Positive Pressure Ventilation Events
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0 events of Positive pressure ventilation
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SECONDARY outcome
Timeframe: day 1Presence or absence of physician intervention requiring endotracheal intubation by provider due to decreased oxygen saturation less than 92%
Outcome measures
| Measure |
Nitrous Oxide Arm
n=43 Participants
Nitrous Oxide arm: Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.
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|---|---|
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Total Number of Endotracheal Intubation Events
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0 events of endotracheal intubation
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SECONDARY outcome
Timeframe: day 1Presence or absence of physician intervention requiring physical stimulation by the provider due to decreased oxygen saturation less than 92%
Outcome measures
| Measure |
Nitrous Oxide Arm
n=43 Participants
Nitrous Oxide arm: Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.
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|---|---|
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Total Number of Physical Stimulation Events
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2 number of subjects
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SECONDARY outcome
Timeframe: day 1Patient satisfaction with use of Nitrous Oxide in anxiolysis and pain control
Outcome measures
| Measure |
Nitrous Oxide Arm
n=43 Participants
Nitrous Oxide arm: Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.
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|---|---|
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Patient, Physician, and Nurse Satisfaction Surveys
The number of subjects satisfied with the level of
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90 percentage of subjects
Interval 71.0 to 97.0
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Patient, Physician, and Nurse Satisfaction Surveys
The number of subjects would use NO in the future
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95 percentage of subjects
Interval 77.0 to 99.0
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Patient, Physician, and Nurse Satisfaction Surveys
Providers satisfied with the analgesia of NO
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82 percentage of subjects
Interval 73.0 to 89.0
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Patient, Physician, and Nurse Satisfaction Surveys
Providers ease of using NO device
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95 percentage of subjects
Interval 77.0 to 99.0
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Patient, Physician, and Nurse Satisfaction Surveys
Physicians would recommend use of NO
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95 percentage of subjects
Interval 77.0 to 99.0
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Patient, Physician, and Nurse Satisfaction Surveys
Nurses would recommend using NO device
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86 percentage of subjects
Interval 65.0 to 95.0
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Patient, Physician, and Nurse Satisfaction Surveys
Nurses felt it improved care
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76 percentage of subjects
Interval 55.0 to 89.0
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SECONDARY outcome
Timeframe: day 1Visual Analog Scale (0-100mm), where 0 mm is minimum pain, and 100 mm is maximum pain.
Outcome measures
| Measure |
Nitrous Oxide Arm
n=43 Participants
Nitrous Oxide arm: Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.
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|---|---|
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Post-Procedure VAS Pain Score
|
37.33 units on a scale
Standard Deviation 32.63
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Adverse Events
Nitrous Oxide Arm
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
Joseph Herres, DO, Director of Research
Einstein Healthcare Network
Phone: 215-456-6666
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place