Trial Outcomes & Findings for Preoxygenation Using THRIVE Versus Facemask in Parturients (NCT NCT03772574)
NCT ID: NCT03772574
Last Updated: 2022-05-24
Results Overview
Duration to achieve EtO2 \>=90% after tidal volume breathing using THRIVE and facemask pre-oxygenation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
91 participants
Primary outcome timeframe
Maximum 8 minutes
Results posted on
2022-05-24
Participant Flow
91 patients provided informed consent in order to reach the recruitment goal of 80 patients. This is the reason for the discrepancy mentioned in the comments.
Participant milestones
| Measure |
Standard Facemask
Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).
Facemask preoxygenation: Standard facemask preoxygenation
|
THRIVE
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
THRIVE and Facemask
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
25
|
24
|
|
Overall Study
COMPLETED
|
40
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
4
|
Reasons for withdrawal
| Measure |
Standard Facemask
Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).
Facemask preoxygenation: Standard facemask preoxygenation
|
THRIVE
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
THRIVE and Facemask
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
0
|
0
|
|
Overall Study
Discomfort
|
0
|
5
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Facemask
n=40 Participants
Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).
Facemask preoxygenation: Standard facemask preoxygenation
|
THRIVE
n=20 Participants
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
THRIVE and Facemask
n=20 Participants
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 4.3 • n=40 Participants
|
35 years
STANDARD_DEVIATION 4.1 • n=20 Participants
|
35 years
STANDARD_DEVIATION 4.4 • n=20 Participants
|
35.3 years
STANDARD_DEVIATION 4.2 • n=80 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=40 Participants
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
80 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=80 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
40 participants
n=40 Participants
|
20 participants
n=20 Participants
|
20 participants
n=20 Participants
|
80 participants
n=80 Participants
|
|
Gravidity
|
2 Pregnancies
n=40 Participants
|
2 Pregnancies
n=20 Participants
|
2 Pregnancies
n=20 Participants
|
2 Pregnancies
n=80 Participants
|
|
Parity
|
1 births
n=40 Participants
|
1 births
n=20 Participants
|
1 births
n=20 Participants
|
1 births
n=80 Participants
|
|
Gestational age
|
38.6 weeks
STANDARD_DEVIATION 1.0 • n=40 Participants
|
38.7 weeks
STANDARD_DEVIATION 1.1 • n=20 Participants
|
39.1 weeks
STANDARD_DEVIATION 0.6 • n=20 Participants
|
38.8 weeks
STANDARD_DEVIATION 0.92 • n=80 Participants
|
|
Baseline respiratory rate
|
11.9 breaths/min
STANDARD_DEVIATION 3.7 • n=40 Participants
|
14.5 breaths/min
STANDARD_DEVIATION 4.1 • n=20 Participants
|
13.3 breaths/min
STANDARD_DEVIATION 3.1 • n=20 Participants
|
12.9 breaths/min
STANDARD_DEVIATION 3.8 • n=80 Participants
|
|
Baseline End Tidal Oxygen (ETO2)
|
15.7 Percent of oxygen in expired breath
STANDARD_DEVIATION 1.2 • n=40 Participants
|
15.7 Percent of oxygen in expired breath
STANDARD_DEVIATION 0.9 • n=20 Participants
|
15.8 Percent of oxygen in expired breath
STANDARD_DEVIATION 1.0 • n=20 Participants
|
15.7 Percent of oxygen in expired breath
STANDARD_DEVIATION 1.1 • n=80 Participants
|
|
Baseline Heart Rate
|
74.4 bpm
STANDARD_DEVIATION 10.8 • n=40 Participants
|
76.1 bpm
STANDARD_DEVIATION 9.7 • n=20 Participants
|
75.2 bpm
STANDARD_DEVIATION 13.9 • n=20 Participants
|
75.1 bpm
STANDARD_DEVIATION 11.3 • n=80 Participants
|
|
Baseline Oxygen Saturation (SPO2)
|
98.0 percent of hemoglobin carrying oxygen
STANDARD_DEVIATION 1.5 • n=40 Participants
|
98.4 percent of hemoglobin carrying oxygen
STANDARD_DEVIATION 1.4 • n=20 Participants
|
98.5 percent of hemoglobin carrying oxygen
STANDARD_DEVIATION 1.4 • n=20 Participants
|
98.2 percent of hemoglobin carrying oxygen
STANDARD_DEVIATION 1.4 • n=80 Participants
|
|
BMI
|
29.1 kg/m^2
STANDARD_DEVIATION 3.7 • n=40 Participants
|
29.5 kg/m^2
STANDARD_DEVIATION 4.8 • n=20 Participants
|
30.4 kg/m^2
STANDARD_DEVIATION 3.8 • n=20 Participants
|
29.5 kg/m^2
STANDARD_DEVIATION 4.0 • n=80 Participants
|
PRIMARY outcome
Timeframe: Maximum 8 minutesDuration to achieve EtO2 \>=90% after tidal volume breathing using THRIVE and facemask pre-oxygenation.
Outcome measures
| Measure |
Standard Facemask
n=40 Participants
Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).
Facemask preoxygenation: Standard facemask preoxygenation
|
THRIVE
n=20 Participants
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
THRIVE and Facemask
n=20 Participants
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
|---|---|---|---|
|
Preoxygenation Duration
|
3.6 minutes
Interval 3.3 to 6.7
|
NA minutes
A value could not be entered, as the longest possible preoxygenation time allotment (8 minutes) was insufficient to produce an EI90
|
NA minutes
A value could not be entered, as the longest possible preoxygenation time allotment (8 minutes) was insufficient to produce an EI90
|
SECONDARY outcome
Timeframe: 3 minutes of pre-oxygenationPopulation: Patients selected to receive 3 minutes of pre-oxygenation
Outcome measures
| Measure |
Standard Facemask
n=14 Participants
Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).
Facemask preoxygenation: Standard facemask preoxygenation
|
THRIVE
n=2 Participants
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
THRIVE and Facemask
n=1 Participants
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
|---|---|---|---|
|
Proportion to Reach End Tidal Oxygen (ETO2) of 90 Percent at 3 Minutes
|
10 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 minutes of preoxygenationPopulation: Patients assigned to recieve 4 minutes of pre-oxygenation
Outcome measures
| Measure |
Standard Facemask
n=26 Participants
Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).
Facemask preoxygenation: Standard facemask preoxygenation
|
THRIVE
n=3 Participants
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
THRIVE and Facemask
n=5 Participants
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
|---|---|---|---|
|
Proportion to Reach EtO2 of 90 Percent at 4 Minutes
|
26 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 5 minutes of preoxygenationPopulation: Patients assigned to receive 5 minutes of pre-oxygenation
Outcome measures
| Measure |
Standard Facemask
Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).
Facemask preoxygenation: Standard facemask preoxygenation
|
THRIVE
n=1 Participants
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
THRIVE and Facemask
n=1 Participants
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
|---|---|---|---|
|
Proportion to Reach EtO2 of 90 Percent at 5 Minutes
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 minutes of preoxygenationPopulation: Patients assigned to receive 6 minutes of preoxygenation
Outcome measures
| Measure |
Standard Facemask
Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).
Facemask preoxygenation: Standard facemask preoxygenation
|
THRIVE
n=1 Participants
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
THRIVE and Facemask
n=1 Participants
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
|---|---|---|---|
|
Proportion to Reach EtO2 of 90 Percent at 6 Minutes
|
—
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 7 minutes of preoxygenationPopulation: Patients assigned to receive 7 minutes of preoxygenation
Outcome measures
| Measure |
Standard Facemask
Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).
Facemask preoxygenation: Standard facemask preoxygenation
|
THRIVE
n=1 Participants
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
THRIVE and Facemask
n=1 Participants
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
|---|---|---|---|
|
Proportion to Reach EtO2 of 90 Percent at 7 Minutes
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 minutes of preoxygenationPopulation: patients assigned to receive 8 minuets of pre-oxygenation
Outcome measures
| Measure |
Standard Facemask
Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).
Facemask preoxygenation: Standard facemask preoxygenation
|
THRIVE
n=12 Participants
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
THRIVE and Facemask
n=11 Participants
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
|---|---|---|---|
|
Proportion to Reach EtO2 of 90 Percent at 8 Minutes
|
0 Participants
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 1 minute after data collectionPatients were asked to rate their comfort with the device on a 5 point Likert Scale: (1=completely uncomfortable, 2=slightly uncomfortable, 3=neutral, 4=slightly comfortable, 5= completely comfortable)
Outcome measures
| Measure |
Standard Facemask
n=40 Participants
Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).
Facemask preoxygenation: Standard facemask preoxygenation
|
THRIVE
n=20 Participants
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
THRIVE and Facemask
n=20 Participants
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
|---|---|---|---|
|
Comfort Score
|
4 Likert Score
Interval 2.0 to 5.0
|
4 Likert Score
Interval 2.0 to 4.0
|
4 Likert Score
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: 1 minute after data collectionAcceptability was measured with a 5-point Likert Score (1= unacceptable, 2=slightly unacceptable,3=neutral, 4=slightly acceptable, 5=acceptable).
Outcome measures
| Measure |
Standard Facemask
n=40 Participants
Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).
Facemask preoxygenation: Standard facemask preoxygenation
|
THRIVE
n=20 Participants
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
THRIVE and Facemask
n=20 Participants
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). Facemask used to minimize air entrainment
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
|
|---|---|---|---|
|
Acceptability Score
|
5 Likert Score
Interval 4.0 to 5.0
|
4.5 Likert Score
Interval 3.75 to 5.0
|
5 Likert Score
Interval 5.0 to 5.0
|
Adverse Events
Standard Facemask
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
THRIVE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
THRIVE and Facemask
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place