NCT02800213

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 9, 2017

Completed
Last Updated

October 9, 2017

Status Verified

October 1, 2017

Enrollment Period

Same day

First QC Date

June 12, 2016

Results QC Date

March 22, 2017

Last Update Submit

October 6, 2017

Conditions

Apnea

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Modified Ambu Spur II bag mask first

EXPERIMENTAL

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: Modified Ambu Spur II bag valve maskDevice: Conventional Ambu Spur II bag valve mask

Conventional Ambu Spur II bag mask first

ACTIVE COMPARATOR

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: Modified Ambu Spur II bag valve maskDevice: Conventional Ambu Spur II bag valve mask

Interventions

Modified Ambu Spur II bag valve maskDEVICE

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 mask firstModified Ambu Spur II bag mask first
Conventional Ambu Spur II bag valve maskDEVICE

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

Conventional Ambu Spur II bag mask firstModified Ambu Spur II bag mask first

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Not trained in basic life support

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 15988424BACKGROUND

  • 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.

    PMID: 24841402BACKGROUND

  • 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.

    PMID: 23937957BACKGROUND

  • 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.

    PMID: 27238825BACKGROUND

MeSH Terms

Conditions

Apnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Michael D. April
Organization
San Antonio Uniformed Services Health Education Consortium
Michael.D.April@post.harvard.edu
2109160808

Study Officials

  • Michael D April, MD, DPhil

    Brooke Army Medical Center

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Director for Research, Emergency Medicine Residency

Study Record Dates

First Submitted

June 12, 2016

First Posted

June 15, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

October 9, 2017

Results First Posted

October 9, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share