Preoxygenation
Conditions
Brief summary
This study aims to determine the duration for pre-oxygenation using THRIVE and facemask for parturients.
Detailed description
We aim to determine the duration required for THRIVE and facemask preoxygenation in parturients for them to achieve ETO2 \>90%.
Interventions
DEVICEFacemask preoxygenation
Standard facemask preoxygenation
DEVICETHRIVE preoxygenation
Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pregnant patients ≥36 weeks gestation. * Non-laboring patients admitted for elective Cesarean delivery under neuraxial anesthesia or induction of labor. * American Society of Anesthesiologists (ASA) class 2.
Exclusion criteria
* Any medical conditions that are likely to affect gas exchange. * Obstructed nasal passage. * Unable to tolerate a tight fitting facemask. * Body Mass Index ≥40 kg/m2. * Patients who are in active labor (i.e. cervical dilation ≥4cm). * Patients who are unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preoxygenation Duration | Maximum 8 minutes | Duration to achieve EtO2 \>=90% after tidal volume breathing using THRIVE and facemask pre-oxygenation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion to Reach End Tidal Oxygen (ETO2) of 90 Percent at 3 Minutes | 3 minutes of pre-oxygenation | — |
| Proportion to Reach EtO2 of 90 Percent at 4 Minutes | 4 minutes of preoxygenation | — |
| Proportion to Reach EtO2 of 90 Percent at 5 Minutes | 5 minutes of preoxygenation | — |
| Proportion to Reach EtO2 of 90 Percent at 8 Minutes | 8 minutes of preoxygenation | — |
| Proportion to Reach EtO2 of 90 Percent at 7 Minutes | 7 minutes of preoxygenation | — |
| Comfort Score | 1 minute after data collection | Patients 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) |
| Acceptability Score | 1 minute after data collection | Acceptability was measured with a 5-point Likert Score (1= unacceptable, 2=slightly unacceptable,3=neutral, 4=slightly acceptable, 5=acceptable). |
| Proportion to Reach EtO2 of 90 Percent at 6 Minutes | 6 minutes of preoxygenation | — |
Countries
Canada
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Standard Facemask Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen).
Facemask preoxygenation: Standard facemask preoxygenation | 40 |
| 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). | 20 |
| 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). | 20 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Discomfort | 0 | 5 | 4 |
| Overall Study | Protocol Violation | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | THRIVE and Facemask | Standard Facemask | Total | THRIVE |
|---|---|---|---|---|
| Age, Continuous | 35 years STANDARD_DEVIATION 4.4 | 35.5 years STANDARD_DEVIATION 4.3 | 35.3 years STANDARD_DEVIATION 4.2 | 35 years STANDARD_DEVIATION 4.1 |
| Baseline End Tidal Oxygen (ETO2) | 15.8 Percent of oxygen in expired breath STANDARD_DEVIATION 1 | 15.7 Percent of oxygen in expired breath STANDARD_DEVIATION 1.2 | 15.7 Percent of oxygen in expired breath STANDARD_DEVIATION 1.1 | 15.7 Percent of oxygen in expired breath STANDARD_DEVIATION 0.9 |
| Baseline Heart Rate | 75.2 bpm STANDARD_DEVIATION 13.9 | 74.4 bpm STANDARD_DEVIATION 10.8 | 75.1 bpm STANDARD_DEVIATION 11.3 | 76.1 bpm STANDARD_DEVIATION 9.7 |
| Baseline Oxygen Saturation (SPO2) | 98.5 percent of hemoglobin carrying oxygen STANDARD_DEVIATION 1.4 | 98.0 percent of hemoglobin carrying oxygen STANDARD_DEVIATION 1.5 | 98.2 percent of hemoglobin carrying oxygen STANDARD_DEVIATION 1.4 | 98.4 percent of hemoglobin carrying oxygen STANDARD_DEVIATION 1.4 |
| Baseline respiratory rate | 13.3 breaths/min STANDARD_DEVIATION 3.1 | 11.9 breaths/min STANDARD_DEVIATION 3.7 | 12.9 breaths/min STANDARD_DEVIATION 3.8 | 14.5 breaths/min STANDARD_DEVIATION 4.1 |
| BMI | 30.4 kg/m^2 STANDARD_DEVIATION 3.8 | 29.1 kg/m^2 STANDARD_DEVIATION 3.7 | 29.5 kg/m^2 STANDARD_DEVIATION 4 | 29.5 kg/m^2 STANDARD_DEVIATION 4.8 |
| Gestational age | 39.1 weeks STANDARD_DEVIATION 0.6 | 38.6 weeks STANDARD_DEVIATION 1 | 38.8 weeks STANDARD_DEVIATION 0.92 | 38.7 weeks STANDARD_DEVIATION 1.1 |
| Gravidity | 2 Pregnancies | 2 Pregnancies | 2 Pregnancies | 2 Pregnancies |
| Parity | 1 births | 1 births | 1 births | 1 births |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment Canada | 20 participants | 40 participants | 80 participants | 20 participants |
| Sex: Female, Male Female | 20 Participants | 40 Participants | 80 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 25 | 0 / 24 |
| other Total, other adverse events | 0 / 42 | 0 / 25 | 0 / 24 |
| serious Total, serious adverse events | 0 / 42 | 0 / 25 | 0 / 24 |
Outcome results
Primary
Preoxygenation Duration
Duration to achieve EtO2 \>=90% after tidal volume breathing using THRIVE and facemask pre-oxygenation.
Time frame: Maximum 8 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Facemask | Preoxygenation Duration | 3.6 minutes |
| THRIVE | Preoxygenation Duration | NA minutes |
| THRIVE and Facemask | Preoxygenation Duration | NA minutes |
Secondary
Acceptability Score
Acceptability was measured with a 5-point Likert Score (1= unacceptable, 2=slightly unacceptable,3=neutral, 4=slightly acceptable, 5=acceptable).
Time frame: 1 minute after data collection
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Facemask | Acceptability Score | 5 Likert Score |
| THRIVE | Acceptability Score | 4.5 Likert Score |
| THRIVE and Facemask | Acceptability Score | 5 Likert Score |
Secondary
Comfort Score
Patients 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)
Time frame: 1 minute after data collection
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Facemask | Comfort Score | 4 Likert Score |
| THRIVE | Comfort Score | 4 Likert Score |
| THRIVE and Facemask | Comfort Score | 4 Likert Score |
Secondary
Proportion to Reach End Tidal Oxygen (ETO2) of 90 Percent at 3 Minutes
Time frame: 3 minutes of pre-oxygenation
Population: Patients selected to receive 3 minutes of pre-oxygenation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Facemask | Proportion to Reach End Tidal Oxygen (ETO2) of 90 Percent at 3 Minutes | 10 Participants |
| THRIVE | Proportion to Reach End Tidal Oxygen (ETO2) of 90 Percent at 3 Minutes | 0 Participants |
| THRIVE and Facemask | Proportion to Reach End Tidal Oxygen (ETO2) of 90 Percent at 3 Minutes | 0 Participants |
Secondary
Proportion to Reach EtO2 of 90 Percent at 4 Minutes
Time frame: 4 minutes of preoxygenation
Population: Patients assigned to recieve 4 minutes of pre-oxygenation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Facemask | Proportion to Reach EtO2 of 90 Percent at 4 Minutes | 26 Participants |
| THRIVE | Proportion to Reach EtO2 of 90 Percent at 4 Minutes | 2 Participants |
| THRIVE and Facemask | Proportion to Reach EtO2 of 90 Percent at 4 Minutes | 4 Participants |
Secondary
Proportion to Reach EtO2 of 90 Percent at 5 Minutes
Time frame: 5 minutes of preoxygenation
Population: Patients assigned to receive 5 minutes of pre-oxygenation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Facemask | Proportion to Reach EtO2 of 90 Percent at 5 Minutes | 0 Participants |
| THRIVE | Proportion to Reach EtO2 of 90 Percent at 5 Minutes | 0 Participants |
| THRIVE and Facemask | Proportion to Reach EtO2 of 90 Percent at 5 Minutes | 0 Participants |
Secondary
Proportion to Reach EtO2 of 90 Percent at 6 Minutes
Time frame: 6 minutes of preoxygenation
Population: Patients assigned to receive 6 minutes of preoxygenation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| THRIVE | Proportion to Reach EtO2 of 90 Percent at 6 Minutes | 0 Participants |
| THRIVE and Facemask | Proportion to Reach EtO2 of 90 Percent at 6 Minutes | 0 Participants |
Secondary
Proportion to Reach EtO2 of 90 Percent at 7 Minutes
Time frame: 7 minutes of preoxygenation
Population: Patients assigned to receive 7 minutes of preoxygenation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Facemask | Proportion to Reach EtO2 of 90 Percent at 7 Minutes | 0 Participants |
| THRIVE | Proportion to Reach EtO2 of 90 Percent at 7 Minutes | 0 Participants |
| THRIVE and Facemask | Proportion to Reach EtO2 of 90 Percent at 7 Minutes | 0 Participants |
Secondary
Proportion to Reach EtO2 of 90 Percent at 8 Minutes
Time frame: 8 minutes of preoxygenation
Population: patients assigned to receive 8 minuets of pre-oxygenation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Facemask | Proportion to Reach EtO2 of 90 Percent at 8 Minutes | 0 Participants |
| THRIVE | Proportion to Reach EtO2 of 90 Percent at 8 Minutes | 1 Participants |
| THRIVE and Facemask | Proportion to Reach EtO2 of 90 Percent at 8 Minutes | 5 Participants |