Trial Outcomes & Findings for Pre-Oxygenation Techniques in Pregnancy (NCT NCT03310723)
NCT ID: NCT03310723
Last Updated: 2020-09-16
Results Overview
Concentration of oxygen at the end of a breath following 3 minutes of tidal volume breathing using either face mask or OptiFlow
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
From baseline ETO2 concentration to the end of 3 minutes of tidal volume breathing
Results posted on
2020-09-16
Participant Flow
Participant milestones
| Measure |
Standard Face Mask Preoxygenation
Tidal volume breathing via a face mask set at 100% oxygen and a rate of 15L/min.
Face Mask preoxygenation: Standard face mask preoxygenation.
|
Optiflow Preoxygenation
Tidal volume breathing with the OptiFlow system applied at 100% oxygen and a flow rate of 30-70L/min.
OptiFlow preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Standard Face Mask Preoxygenation
Tidal volume breathing via a face mask set at 100% oxygen and a rate of 15L/min.
Face Mask preoxygenation: Standard face mask preoxygenation.
|
Optiflow Preoxygenation
Tidal volume breathing with the OptiFlow system applied at 100% oxygen and a flow rate of 30-70L/min.
OptiFlow preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Face Mask Preoxygenation
n=20 Participants
Tidal volume breathing for via a face mask set at 100% oxygen and a rate of 15L/min.
Face Mask preoxygenation: Standard face mask preoxygenation.
|
Optiflow Preoxygenation
n=17 Participants
Tidal volume breathing with the OptiFlow system applied at 100% oxygen and a flow rate of 30-70L/min.
OptiFlow preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.8 years
STANDARD_DEVIATION 4.3 • n=20 Participants
|
34.6 years
STANDARD_DEVIATION 5.3 • n=17 Participants
|
34.7 years
STANDARD_DEVIATION 4.8 • n=37 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=20 Participants
|
17 Participants
n=17 Participants
|
37 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=37 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
20 participants
n=20 Participants
|
17 participants
n=17 Participants
|
37 participants
n=37 Participants
|
|
Baseline end-tidal oxygen concentration (EtO2)
|
15.9 Percentage units
STANDARD_DEVIATION 1.2 • n=20 Participants
|
15.9 Percentage units
STANDARD_DEVIATION 1.5 • n=17 Participants
|
15.9 Percentage units
STANDARD_DEVIATION 1.35 • n=37 Participants
|
PRIMARY outcome
Timeframe: From baseline ETO2 concentration to the end of 3 minutes of tidal volume breathingConcentration of oxygen at the end of a breath following 3 minutes of tidal volume breathing using either face mask or OptiFlow
Outcome measures
| Measure |
Standard Face Mask Preoxygenation
n=20 Participants
Tidal volume breathing via a face mask set at 100% oxygen and a rate of 15L/min.
Face Mask preoxygenation: Standard face mask preoxygenation.
|
Optiflow Preoxygenation
n=17 Participants
Tidal volume breathing with the OptiFlow system applied at 100% oxygen and a flow rate of 30-70L/min.
OptiFlow preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
|---|---|---|
|
End Tidal Oxygen Concentration (ETO2) Following Tidal Volume Breathing Using Either Face Mask or OptiFlow
|
91.0 Percentage units of end-tidal oxygen
Interval 89.3 to 92.7
|
87.4 Percentage units of end-tidal oxygen
Interval 85.5 to 89.2
|
SECONDARY outcome
Timeframe: From baseline ETO2 concentration to the end of 8 vital capacity breaths (approximately 3 minutes)Concentration of oxygen at the end of a breath following 8 deep breaths using either face mask or OptiFlow
Outcome measures
| Measure |
Standard Face Mask Preoxygenation
n=20 Participants
Tidal volume breathing via a face mask set at 100% oxygen and a rate of 15L/min.
Face Mask preoxygenation: Standard face mask preoxygenation.
|
Optiflow Preoxygenation
n=17 Participants
Tidal volume breathing with the OptiFlow system applied at 100% oxygen and a flow rate of 30-70L/min.
OptiFlow preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
|---|---|---|
|
End Tidal Oxygen Concentration (ETO2) Following Vital Capacity Breaths Using Either Face Mask or OptiFlow
|
91.8 Percentage units
Interval 90.1 to 93.4
|
85.9 Percentage units
Interval 84.1 to 87.7
|
Adverse Events
Standard Face Mask Preoxygenation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Optiflow Preoxygenation
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
Research Assistant
BC Women's Hospital, Department of Anesthesia
Phone: 604-875-2424
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place