Trial Outcomes & Findings for Ventilation Using a Bag Valve Mask With Integrated Internal Handle (NCT NCT02792049)

NCT ID: NCT02792049

Last Updated: 2016-10-25

Results Overview

Each participant was asked to provide BVM ventilation using the assigned devices at a rate of 10 breaths per minute for 3 minutes for a total of 30 breaths. Tidal volume of each delivered breath was recorded in milliliters

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 70 participants
• Primary outcome timeframe: 3 minutes
• Results posted on: 2016-10-25

Participant Flow

Participant milestones

Measure	Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM A healthcare provider 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). The subject then repeats these procedures using an unmodified Ambu bag valve mask.	Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM A healthcare provider 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). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
Overall Study STARTED	35	35
Overall Study COMPLETED	35	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ventilation Using a Bag Valve Mask With Integrated Internal Handle

Baseline characteristics by cohort

Measure	Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM n=35 Participants A healthcare provider 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). The subject then repeats these procedures using an unmodified Ambu bag valve mask.	Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM n=35 Participants A healthcare provider 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). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.	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	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	24 Participants n=7 Participants	50 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 minutes

Each participant was asked to provide BVM ventilation using the assigned devices at a rate of 10 breaths per minute for 3 minutes for a total of 30 breaths. Tidal volume of each delivered breath was recorded in milliliters

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).	Conventional Ambu Spur II 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).
Mean Received Tidal Volume	681 milliliters Standard Deviation 148	591 milliliters Standard Deviation 142

SECONDARY outcome

Timeframe: Within 10 minutes of study completion

Likert scale measuring subject's perceived ease of use of the modified BVM device from not at all easy to use (1) to very easy to use (5).

Outcome measures

Measure	Modified 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).	Conventional 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).
Modified Bag Valve Mask (BVM) Ease of Use	5 Units on a scale Interval 4.0 to 5.0	5 Units on a scale Interval 4.0 to 5.0

SECONDARY outcome

Timeframe: Within 10 minutes of study completion

Subjects response using a Likert scale (1-5) regarding their perceptions of whether the modified BVM forms a better seal compared to a standard BVM: 1 (much worse seal formation) to 5 (much better seal formation).

Outcome measures

Measure	Modified 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).	Conventional 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).
Modified Bag Valve Mask (BVM) Better Seal Formation	4 Units on a scale Interval 3.0 to 4.0	4 Units on a scale Interval 3.0 to 5.0

SECONDARY outcome

Timeframe: Within 10 minutes of study completion

Subject reported willingness to use the modified BVM in a real life emergency situation as measured on a Likert scale ranging 1 (not at all willing to use) to 5 (very willing to use).

Outcome measures

Measure	Modified 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).	Conventional 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).
Modified Bag Valve Mask (BVM) Willingness to Use in Emergency Situation	5 Units on a scale Interval 4.0 to 5.0	5 Units on a scale Interval 4.0 to 5.0

SECONDARY outcome

Timeframe: Within 10 minutes of study completion

Each subject provides a binary response as to whether he/she overall prefers using the modified BVM instead of the conventional BVM.

Outcome measures

Measure	Modified 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).	Conventional 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).
Number of Participants Who Preferred the Modified Bag Valve Mask (BVM)	28 participants	28 participants

Adverse Events

Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM

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

Brooke Army Medical Center

Phone: (210) 916 - 0808

Email: Michael.D.April@post.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place