Ventilation Using a Bag Valve Mask With Integrated Internal Handle

Not Applicable

Completed

Interventions: Device: Modified Ambu Spur II bag valve mask
Device: Conventional Ambu Spur II bag valve mask

Brief Summary: Investigators compared tidal volumes for single rescuer ventilation using a modified bag valve mask with an integrated internal handle versus a conventional bag valve mask in a manikin model.

Detailed Description: This was a prospective, randomized, crossover study to assess the tidal volume delivered using a standard and modified bag valve mask (BVM) device in a manikin airway model. Data was collected from July 2015 through October 2015 at the San Antonio Military Medical Center. Emergency medicine providers (physicians, physician assistants, residents, nurses, medics) were randomized to device order. Prior to participation each participant filled out a survey indicating their job status, gender, years of medical experience, and experience level with BVM ventilation. Hand grip strength and size (length, width, span) were measured. Each participant was then 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. After a 3 minute rest period, testing was repeated with the second device. After ventilation with each device, participants completed an anonymous questionnaire that used a Likert scale to assess perceived qualities of the modified device including ease of use, ability to provide a superior mask seal, willingness to use in an emergency situation, and overall preference between the two devices. Each participant served as his/her own control.

Recruitment & Eligibility

Inclusion Criteria

Emergency Department healthy volunteers (physician assistants, residents, paramedics, nurses, medics, respiratory therapists.

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Modified Ambu Spur II bag valve mask	Modified 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).
Conventional Ambu Spur II bag valve mask	Conventional 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).

Primary Outcome Measures

Name	Time	Method
Mean Received Tidal Volume	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

Secondary Outcome Measures

Name	Time	Method
Modified Bag Valve Mask (BVM) Better Seal Formation	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).
Number of Participants Who Preferred the Modified Bag Valve Mask (BVM)	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.
Modified Bag Valve Mask (BVM) Ease of Use	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).
Modified Bag Valve Mask (BVM) Willingness to Use in Emergency Situation	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).