Ventilation Using a Bag Valve Mask With Integrated Internal Handle

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ClinicalTrials.gov Identifier: NCT02792049

Recruitment Status : Completed

First Posted : June 7, 2016

Results First Posted : July 25, 2016

Last Update Posted : October 25, 2016

Sponsor:

Information provided by (Responsible Party):

Michael D. April, Brooke Army Medical Center

Study Description

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.

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. 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	70 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Single (Investigator)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	July 2015
Actual Primary Completion Date :	October 2015
Actual Study Completion Date :	October 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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).	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 integrated internal handle
Active Comparator: 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).	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

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (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

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): NCT02792049

Locations

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United States, Texas
San Antonio Military Medical Center
San Antonio, Texas, United States, 78234

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

Publications:

Davidovic L, LaCovey D, Pitetti RD. Comparison of 1- versus 2-person bag-valve-mask techniques for manikin ventilation of infants and children. Ann Emerg Med. 2005 Jul;46(1):37-42.

Braude DA, Tawil I, Gerstein NS, Carey MC, Petersen TR. Comparison of bag-valve-mask hand-sealing techniques in a simulated model. Ann Emerg Med. 2014 Jun;63(6):784-5. doi: 10.1016/j.annemergmed.2014.01.037.

Otten D, Liao MM, Wolken R, Douglas IS, Mishra R, Kao A, Barrett W, Drasler E, Byyny RL, Haukoos JS. Comparison of bag-valve-mask hand-sealing techniques in a simulated model. Ann Emerg Med. 2014 Jan;63(1):6-12.e3. doi: 10.1016/j.annemergmed.2013.07.014. Epub 2013 Aug 9.

Amack AJ, Barber GA, Ng PC, Smith TB, April MD. Comparison of Ventilation With One-Handed Mask Seal With an Intraoral Mask Versus Conventional Cuffed Face Mask in a Cadaver Model: A Randomized Crossover Trial. Ann Emerg Med. 2017 Jan;69(1):12-17. doi: 10.1016/j.annemergmed.2016.04.017. Epub 2016 May 27.

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Responsible Party:	Michael D. April, Assistant Director for Research, Emergency Medicine Residency, Brooke Army Medical Center
ClinicalTrials.gov Identifier:	NCT02792049
Other Study ID Numbers:	C.2015.046e
First Posted:	June 7, 2016 Key Record Dates
Results First Posted:	July 25, 2016
Last Update Posted:	October 25, 2016
Last Verified:	September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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