Ventilation Using a Bag Valve Mask With Supplemental External Handle

Apnea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02800213
• Other study ID #: C.2016.136e
• Status: Completed
• Phase: N/A
• First received: June 12, 2016
• Last updated: October 6, 2017
• Start date: May 2016
• Est. completion date: May 2016

Study information

• Verified date: October 2017
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Not trained in basic life support

Related Conditions & MeSH terms

• Apnea

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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