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Clinical Trials/NCT02792049
NCT02792049
Completed
Not Applicable

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

Brooke Army Medical Center1 site in 1 country70 target enrollmentJuly 2015
ConditionsApnea

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Apnea
Sponsor
Brooke Army Medical Center
Enrollment
70
Locations
1
Primary Endpoint
Mean Received Tidal Volume
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
October 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael D. April

Assistant Director for Research, Emergency Medicine Residency

Brooke Army Medical Center

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not trained in basic life support

Outcomes

Primary Outcomes

Mean Received Tidal Volume

Time Frame: 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 Outcomes

  • Modified Bag Valve Mask (BVM) Better Seal Formation(Within 10 minutes of study completion)
  • Number of Participants Who Preferred the Modified Bag Valve Mask (BVM)(Within 10 minutes of study completion)
  • Modified Bag Valve Mask (BVM) Ease of Use(Within 10 minutes of study completion)
  • Modified Bag Valve Mask (BVM) Willingness to Use in Emergency Situation(Within 10 minutes of study completion)

Study Sites (1)

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