Ventilation Using a Bag Valve Mask With Integrated Internal Handle

Study Overview
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Brief Summary
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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
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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.

Official Title
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Single Rescuer Ventilation Using a Bag Valve Mask With Integrated Internal Handle Versus Standard Bag Valve Mask in a Manikin Model: A Randomized Crossover Trial

Conditions
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Apnea

Intervention / Treatment
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* Device: Modified Ambu Spur II bag valve mask
* Device: Conventional Ambu Spur II bag valve mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Emergency Department healthy volunteers (physician assistants, residents, paramedics, nurses, medics, respiratory therapists. Exclusion Criteria: Not trained in basic life support

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Ambu Spur II bag valve mask<br>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). | Device: Modified Ambu Spur II bag valve mask<br>* Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with integrated internal handle<br>|
| Active Comparator: Conventional Ambu Spur II bag valve mask<br>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). | Device: Conventional Ambu Spur II bag valve mask<br>* Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Received Tidal Volume | 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 | 3 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Bag Valve Mask (BVM) Ease of Use | 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). | Within 10 minutes of study completion | 
| Modified Bag Valve Mask (BVM) Better Seal Formation | 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). | Within 10 minutes of study completion | 
| Modified Bag Valve Mask (BVM) Willingness to Use in Emergency Situation | 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). | Within 10 minutes of study completion | 
| Number of Participants Who Preferred the Modified Bag Valve Mask (BVM) | Each subject provides a binary response as to whether he/she overall prefers using the modified BVM instead of the conventional BVM. | Within 10 minutes of study completion |