Trial Outcomes & Findings for Ventilation Using a Bag Valve Mask With Supplemental External Handle (NCT NCT02800213)
NCT ID: NCT02800213
Last Updated: 2017-10-09
Results Overview
Mean received tidal volume for 30 breaths delivered by the subjects over three minutes as measured via the RespiTrainer Advance manikin model monitor output.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
3 minutes
Results posted on
2017-10-09
Participant Flow
Participant milestones
| Measure |
Modified Then Conventional Ambu Spur II Bag Valve Mask
A health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).
Modified Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with a supplemental external handle.
After completion, subjects repeat all these procedures using a conventional Ambu Spur II bag valve mask.
|
Conventional Then Modified Ambu Spur II Bag Valve Mask
A health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).
Conventional Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask
After completion, subjects repeat all these procedures using the modified Ambu Spur II bag valve mask.
|
|---|---|---|
|
First Intervention
STARTED
|
35
|
35
|
|
First Intervention
COMPLETED
|
35
|
35
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
35
|
35
|
|
Second Intervention
COMPLETED
|
35
|
35
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ventilation Using a Bag Valve Mask With Supplemental External Handle
Baseline characteristics by cohort
| Measure |
Modified Then Conventional Ambu Spur II Bag Valve Mask
n=35 Participants
A health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).
Modified Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with a supplemental external handle.
After completion, subjects repeat all these procedures using a conventional Ambu Spur II bag valve mask.
|
Conventional Then Modified Ambu Spur II Bag Valve Mask
n=35 Participants
A health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).
Conventional Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask.
After completion, subjects repeat all these procedures using the modified Ambu Spur II bag valve mask.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
35 participants
n=7 Participants
|
70 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 minutesMean received tidal volume for 30 breaths delivered by the subjects over three minutes as measured via the RespiTrainer Advance manikin model monitor output.
Outcome measures
| Measure |
Modified Ambu Spur II Bag Valve Mask
n=70 Participants
A health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).
Modified Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with a supplemental external handle.
After completion, subjects repeat all these procedures using a conventional Ambu Spur II bag valve mask.
|
Conventional Bag Valve Mask
n=70 Participants
A health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).
Conventional Ambu Spur II bag valve mask: Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask.
After completion, subjects repeat all these procedures using the modified Ambu Spur II bag valve mask.
|
|---|---|---|
|
Received Tidal Volume
|
662 milliliters
Interval 611.0 to 707.0
|
681 milliliters
Interval 635.0 to 731.0
|
Adverse Events
Modified Ambu Spur II Bag Valve Mask
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Ambu Spur II Bag Valve Mask
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
Dr. Michael D. April
San Antonio Uniformed Services Health Education Consortium
Phone: 2109160808
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place