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We will conduct this study to show that it is possible to deliver air through a Frova bougie and an Ambu® bag.
Participants will be invited to squeeze an Ambu® bag connected to a Frova bougie, and we will measure the volume of air delivered and peak pressure generated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maximum bimanual compression | Other | Squeeze through Frova bougie with maximum bimanual compression |
|
| Normal bimanual compression | Other | Squeeze through Frova bougie with normal bimanual compression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Frova bougie | Other | Squeezing an Ambu bag and delivering air through a Frova bougie. Measuring mean volumes of air delivered and peak pressures generated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tidal Volume (ml) | volume of air delivered via Frova bougie (milliliters) | 15 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon Massey, FRCPC | BC Women's Hospital,UBC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Women's Hospital | Vancouver | British Columbia | V5X1T3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30756337 | Derived | Dewan P, Taylor J, Gunka V, Albert A, Massey S. Manual volume delivery via Frova Intubating Introducer: a bench research study. Can J Anaesth. 2019 May;66(5):527-531. doi: 10.1007/s12630-019-01308-9. Epub 2019 Feb 12. |
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This study design involves a cross-over of participants (i.e., participants are randomly assigned to one of the four groups after which they crossover to the other 3).
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| ID | Title | Description |
|---|---|---|
| FG000 | Maximum and Normal Effort Using Long and Short Frova Bougies | In a random order, participants would squeeze an Ambu bag attached to a long or short Frova bougie using both maximum and normal effort. As such, participants performed a total of 4 sets of squeezes (maximum effort: long, normal effort: long, maximum effort: short, and normal effort: short) in a random order. Frova bougie: Squeezing an Ambu bag attached to a Frova bougie and measuring mean volumes of air delivered. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Maximum and Normal Effort Using Long and Short Frova Bougies | In a random order, participants would squeeze an Ambu bag attached to a long or short Frova bougie using both maximum and normal effort. As such, participants performed a total of 4 sets of squeezes (maximum effort: long, normal effort: long, maximum effort: short, and normal effort: short) in a random order. Frova bougie: Squeezing an Ambu bag attached to a Frova bougie and measuring mean volumes of air delivered. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Tidal Volume (ml) | volume of air delivered via Frova bougie (milliliters) | Posted | Mean | Standard Deviation | tidal volume (ml) | 15 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 | Maximum and Normal Effort Using Long and Short Frova Bougies | In a random order, participants would squeeze an Ambu bag attached to a long or short Frova bougie using both maximum and normal effort. As such, participants performed a total of 4 sets of squeezes (maximum effort: long, normal effort: long, maximum effort: short, and normal effort: short) in a random order. Frova bougie: Squeezing an Ambu bag attached to a Frova bougie and measuring mean volumes of air delivered. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Taylor | UBC Department of Anesthesia - BC Women's Hospital | 604-875-2424 | 6076 | james.taylor1@phsa.ca |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Maximum Effort: Short |
Squeeze through short Frova bougie with maximum effort Frova bougie: Squeezing Ambu bag and ventilating through a Frova bougie and measuring mean volumes of air delivered |
| OG003 | Normal Effort: Short | Squeeze through short Frova bougie with normal effort Frova bougie: Squeezing Ambu bag and ventilating through a Frova bougie and measuring mean volumes of air delivered |
|
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| 0 |
| 35 |
| 0 |
| 35 |
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