Trial Outcomes & Findings for Oxygenation Via Frova Bougie and Ambu Bag (NCT NCT02786355)
NCT ID: NCT02786355
Last Updated: 2018-12-28
Results Overview
volume of air delivered via Frova bougie (milliliters)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
15 minutes
Results posted on
2018-12-28
Participant Flow
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).
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxygenation Via Frova Bougie and Ambu Bag
Baseline characteristics by cohort
| Measure |
Maximum and Normal Effort Using Long and Short Frova Bougies
n=35 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 minutesvolume of air delivered via Frova bougie (milliliters)
Outcome measures
| Measure |
Maximum Effort: Long
n=35 Participants
Squeeze through long Frova bougie with maximum effort
Frova bougie: Squeezing Ambu bag and ventilating through a Frova bougie and measuring mean volumes of air delivered
|
Normal Effort: Long
n=35 Participants
Squeeze through long Frova bougie with normal effort
Frova bougie: Squeezing Ambu bag and ventilating through a Frova bougie and measuring mean volumes of air delivered
|
Maximum Effort: Short
n=35 Participants
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
|
Normal Effort: Short
n=35 Participants
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
|
|---|---|---|---|---|
|
Tidal Volume (ml)
|
954.8 tidal volume (ml)
Standard Deviation 120.7
|
554.4 tidal volume (ml)
Standard Deviation 131.3
|
893.5 tidal volume (ml)
Standard Deviation 171.6
|
542.9 tidal volume (ml)
Standard Deviation 132.9
|
Adverse Events
Maximum and Normal Effort Using Long and Short Frova Bougies
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
James Taylor
UBC Department of Anesthesia - BC Women's Hospital
Phone: 604-875-2424
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place