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This study aims to determine the duration for pre-oxygenation using THRIVE and facemask for parturients.
We aim to determine the duration required for THRIVE and facemask preoxygenation in parturients for them to achieve ETO2 >90%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THRIVE | Experimental | THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen). |
|
| Facemask | Active Comparator | Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Facemask preoxygenation | Device | Standard facemask preoxygenation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Preoxygenation Duration | Duration to achieve EtO2 >=90% after tidal volume breathing using THRIVE and facemask pre-oxygenation. | Maximum 8 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anton Chau, MD MMSc | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Women's Hospital | Vancouver | British Columbia | V6H 3N1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32048278 | Derived | Au K, Shippam W, Taylor J, Albert A, Chau A. Determining the effective pre-oxygenation interval in obstetric patients using high-flow nasal oxygen and standard flow rate facemask: a biased-coin up-down sequential allocation trial. Anaesthesia. 2020 May;75(5):609-616. doi: 10.1111/anae.14995. Epub 2020 Feb 11. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Facemask | Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen). Facemask preoxygenation: Standard facemask preoxygenation |
| FG001 | 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). |
| FG002 | 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Facemask | Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen). Facemask preoxygenation: Standard facemask preoxygenation |
| BG001 | THRIVE |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Preoxygenation Duration | Duration to achieve EtO2 >=90% after tidal volume breathing using THRIVE and facemask pre-oxygenation. | Posted | Mean | 95% Confidence Interval | minutes | Maximum 8 minutes |
|
7 months
Patients are not at risk of any adverse events other than some discomfort during preoxygentaion. The study team was careful to avoid complications of pressure related damage to the lungs, by limiting the period of time patients were exposed to high flow oxygen to 8 minutes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Facemask | Facemask preoxygenation (tidal volume breathing via a face mask set at 100% oxygen). Facemask preoxygenation: Standard facemask preoxygenation |
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Our results are specific to healthy parturients using standard facemasks, or a high oxygen flow rate of 50L/min, and cannot be generalized to other techniques or populations. 9 parturients left the study due to discomfort, which may bias outcomes
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anthony Chau | BC Women's Hospital | 604-875-2158 | anton.chau@ubc.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 8, 2019 | May 6, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| THRIVE preoxygenation |
| Device |
Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE). |
|
|
| Proportion to Reach EtO2 of 90 Percent at 5 Minutes |
| 5 minutes of preoxygenation |
| Proportion to Reach EtO2 of 90 Percent at 6 Minutes | 6 minutes of preoxygenation |
| Proportion to Reach EtO2 of 90 Percent at 7 Minutes | 7 minutes of preoxygenation |
| Proportion to Reach EtO2 of 90 Percent at 8 Minutes | 8 minutes of preoxygenation |
| 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) | 1 minute after data collection |
| Acceptability Score | Acceptability was measured with a 5-point Likert Score (1= unacceptable, 2=slightly unacceptable,3=neutral, 4=slightly acceptable, 5=acceptable). | 1 minute after data collection |
THRIVE preoxygenation (tidal volume breathing with the OptiFlow system applied at 100% oxygen).
THRIVE preoxygenation: Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
| BG002 | 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). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gravidity | Median | Inter-Quartile Range | Pregnancies |
|
| Parity | Median | Inter-Quartile Range | births |
|
| Gestational age | Mean | Standard Deviation | weeks |
|
| Baseline respiratory rate | Mean | Standard Deviation | breaths/min |
|
| Baseline End Tidal Oxygen (ETO2) | Mean | Standard Deviation | Percent of oxygen in expired breath |
|
| Baseline Heart Rate | Mean | Standard Deviation | bpm |
|
| Baseline Oxygen Saturation (SPO2) | Mean | Standard Deviation | percent of hemoglobin carrying oxygen |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG002 |
| 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). |
|
|
| Secondary | Proportion to Reach End Tidal Oxygen (ETO2) of 90 Percent at 3 Minutes | Patients selected to receive 3 minutes of pre-oxygenation | Posted | Count of Participants | Participants | 3 minutes of pre-oxygenation |
|
|
|
| Secondary | Proportion to Reach EtO2 of 90 Percent at 4 Minutes | Patients assigned to recieve 4 minutes of pre-oxygenation | Posted | Count of Participants | Participants | 4 minutes of preoxygenation |
|
|
|
| Secondary | Proportion to Reach EtO2 of 90 Percent at 5 Minutes | Patients assigned to receive 5 minutes of pre-oxygenation | Posted | Count of Participants | Participants | 5 minutes of preoxygenation |
|
|
|
| Secondary | Proportion to Reach EtO2 of 90 Percent at 6 Minutes | Patients assigned to receive 6 minutes of preoxygenation | Posted | Count of Participants | Participants | 6 minutes of preoxygenation |
|
|
|
| Secondary | Proportion to Reach EtO2 of 90 Percent at 7 Minutes | Patients assigned to receive 7 minutes of preoxygenation | Posted | Count of Participants | Participants | 7 minutes of preoxygenation |
|
|
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| Secondary | Proportion to Reach EtO2 of 90 Percent at 8 Minutes | patients assigned to receive 8 minuets of pre-oxygenation | Posted | Count of Participants | Participants | 8 minutes of preoxygenation |
|
|
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| 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) | Posted | Median | Inter-Quartile Range | Likert Score | 1 minute after data collection |
|
|
|
| Secondary | Acceptability Score | Acceptability was measured with a 5-point Likert Score (1= unacceptable, 2=slightly unacceptable,3=neutral, 4=slightly acceptable, 5=acceptable). | Posted | Median | Inter-Quartile Range | Likert Score | 1 minute after data collection |
|
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| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | 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). | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | 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). | 0 | 24 | 0 | 24 | 0 | 24 |
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| Male |
|