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Ventilation Using a Bag Valve Mask With Integrated Internal Handle

NCT ID: NCT02792049

Last Updated: 2016-10-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-10-31

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.

Conditions

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Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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).

Group Type EXPERIMENTAL

Modified Ambu Spur II bag valve mask

Intervention Type DEVICE

Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with integrated internal handle

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).

Group Type ACTIVE_COMPARATOR

Conventional Ambu Spur II bag valve mask

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brooke Army Medical Center

FED

Sponsor Role lead

Responsible Party

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Michael D. April

Assistant Director for Research, Emergency Medicine Residency

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael D April, MD, DPhil

Role: STUDY_DIRECTOR

Brooke Army Medical Center

Locations

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San Antonio Military Medical Center

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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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. doi: 10.1016/j.annemergmed.2005.02.005.

Reference Type BACKGROUND
PMID: 15988424 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 24841402 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23937957 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27238825 (View on PubMed)

Other Identifiers

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C.2015.046e

Identifier Type: -

Identifier Source: org_study_id