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A trial comparing outcomes of two pre-oxygenation techniques in obstetric patients.
Pre-oxygenation is performed prior to general anesthesia to prevent hypoxia during airway management. It is typically performed using a standard tight-fitting face mask; however, recent advances in oxygenation have occurred through the use of trans-nasal oxygen delivery devices, such as OptiFlow. There is limited evidence of the use of OptiFlow in the pregnant patient, and as such, this study aims to show that OptiFlow is as effective at pre-oxygenation as a standard tight-fitting face-mask technique in the pregnant population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Face Mask Preoxygenation | Active Comparator | Tidal volume breathing for via a face mask set at 100% oxygen and a rate of 15L/min. |
|
| Optiflow Preoxygenation | Experimental | Tidal volume breathing with the OptiFlow system applied at 100% oxygen and a flow rate of 30-70L/min. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Face Mask preoxygenation | Device | Standard face mask preoxygenation. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| End Tidal Oxygen Concentration (ETO2) Following Tidal Volume Breathing Using Either Face Mask or OptiFlow | Concentration of oxygen at the end of a breath following 3 minutes of tidal volume breathing using either face mask or OptiFlow | From baseline ETO2 concentration to the end of 3 minutes of tidal volume breathing |
| Measure | Description | Time Frame |
|---|---|---|
| End Tidal Oxygen Concentration (ETO2) Following Vital Capacity Breaths Using Either Face Mask or OptiFlow | Concentration of oxygen at the end of a breath following 8 deep breaths using either face mask or OptiFlow | From baseline ETO2 concentration to the end of 8 vital capacity breaths (approximately 3 minutes) |
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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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Face Mask Preoxygenation | 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. |
| BG001 | Optiflow Preoxygenation |
| 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 | End Tidal Oxygen Concentration (ETO2) Following Tidal Volume Breathing Using Either Face Mask or OptiFlow | Concentration of oxygen at the end of a breath following 3 minutes of tidal volume breathing using either face mask or OptiFlow | Posted | Median | Inter-Quartile Range | Percentage units of end-tidal oxygen | From baseline ETO2 concentration to the end of 3 minutes of tidal volume breathing |
|
Adverse event data were collected during study procedures (i.e., from baseline measurements to end of pre-oxygenation at 3 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 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Assistant | BC Women's Hospital, Department of Anesthesia | 604-875-2424 | 6076 | james.taylor1@phsa.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 | Oct 23, 2019 | Sep 10, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| OptiFlow preoxygenation |
| Device |
Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE). |
|
|
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).
| BG002 | 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 |
|
| Baseline end-tidal oxygen concentration (EtO2) | Mean | Standard Deviation | Percentage units |
|
|
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| Secondary | End Tidal Oxygen Concentration (ETO2) Following Vital Capacity Breaths Using Either Face Mask or OptiFlow | Concentration of oxygen at the end of a breath following 8 deep breaths using either face mask or OptiFlow | Posted | Median | Inter-Quartile Range | Percentage units | From baseline ETO2 concentration to the end of 8 vital capacity breaths (approximately 3 minutes) |
|
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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). | 0 | 20 | 0 | 20 | 0 | 20 |
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