Ventilation Using a Bag Valve Mask With Supplemental External Handle

Brooke Army Medical Center

Status: Completed

Conditions: Apnea

Treatments: Device: Modified Ambu Spur II bag valve mask; Device: Conventional Ambu Spur II bag valve mask

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02800213

C.2016.136e

Details and patient eligibility

About

Investigators compared tidal volumes for single rescuer ventilation using a modified bag valve mask with a supplemental external handle versus a conventional bag valve mask in a manikin model.

Full 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. The modified device comprised a standard bag valve mask with supplemental external bar. Data was collected during May 2016 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Not trained in basic life support

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Modified Ambu Spur II bag mask first

Experimental group

Description:

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). Volunteer then repeats the procedures using a conventional Ambu Spur II bag valve mask.

Treatment:

Device: Modified Ambu Spur II bag valve mask

Device: Conventional Ambu Spur II bag valve mask

Conventional Ambu Spur II bag mask first

Active Comparator group

Description:

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). Volunteer then repeats the procedures using a modified Ambu Spur II bag valve mask.

Treatment:

Device: Modified Ambu Spur II bag valve mask

Device: Conventional Ambu Spur II bag valve mask