Ventilation Using a Bag Valve Mask With Supplemental External Handle

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

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.

Study Overview

• Status: Completed
• Conditions: Apnea
• Intervention / Treatment: Device: Conventional Ambu Spur II bag valve mask; Device: Modified Ambu Spur II bag valve mask

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Not trained in basic life support

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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: Conventional Ambu Spur II bag valve mask; Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) 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
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: Conventional Ambu Spur II bag valve mask; Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Received Tidal Volume	Mean received tidal volume for 30 breaths delivered by the subjects over three minutes as measured via the RespiTrainer Advance manikin model monitor output.	3 minutes

Collaborators and Investigators

• Sponsor: Brooke Army Medical Center
• Investigators: Study Director: Michael D April, MD, DPhil, Brooke Army Medical Center

Publications and helpful links

General 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. doi: 10.1016/j.annemergmed.2005.02.005.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: June 12, 2016
• First Submitted That Met QC Criteria: June 12, 2016
• First Posted (Estimate): June 15, 2016

Study Record Updates

• Last Update Posted (Actual): October 9, 2017
• Last Update Submitted That Met QC Criteria: October 6, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: C.2016.136e

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO