NCT02792049

Ventilation Using a Bag Valve Mask With Integrated Internal Handle

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Brooke Army Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Apnea

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2016-06-07
• Last updated: 2016-10-25
• Results posted: 2016-07-25

Locations

1 site across 1 country: United States