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Ventilation Using a Bag Valve Mask With Supplemental External Handle

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ClinicalTrials.gov Identifier: NCT02800213
Recruitment Status : Completed
First Posted : June 15, 2016
Results First Posted : October 9, 2017
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
Michael D. April, Brooke Army Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Apnea Device: Modified Ambu Spur II bag valve mask Device: Conventional Ambu Spur II bag valve mask Not Applicable

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. 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single Rescuer Ventilation Using a Bag Valve Mask With Supplemental External Handle Versus Standard Bag Valve Mask in a Manikin Model: A Randomized Crossover Trial
Study Start Date : May 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Modified Ambu Spur II bag mask first
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.
 Device: Modified Ambu Spur II bag valve mask
Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with a supplemental external handle

Device: Conventional Ambu Spur II bag valve mask
Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask
Active Comparator: Conventional Ambu Spur II bag mask first
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.
 Device: Modified Ambu Spur II bag valve mask
Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with a supplemental external handle

Device: Conventional Ambu Spur II bag valve mask
Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask


Outcome Measures
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Primary Outcome Measures :
  1. Received Tidal Volume [ Time Frame: 3 minutes ]
    Mean received tidal volume for 30 breaths delivered by the subjects over three minutes as measured via the RespiTrainer Advance manikin model monitor output.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not trained in basic life support
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800213


Sponsors and Collaborators
Brooke Army Medical Center
Investigators
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Study Director: Michael D April, MD, DPhil Brooke Army Medical Center
More Information
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Publications:

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Responsible Party: Michael D. April, Assistant Director for Research, Emergency Medicine Residency, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT02800213    
Other Study ID Numbers: C.2016.136e
First Posted: June 15, 2016    Key Record Dates
Results First Posted: October 9, 2017
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No