Nu-Mask Intraoral Airway Device Versus Conventional Bag Valve Mask Ventilation Crossover Trial
Comparison of Air Leak During Ventilation With Nu-Mask Intraoral Airway Device Versus Conventional Bag Valve Mask in a Cadaver Model: A Randomized Crossover Trial
1 other identifier
interventional
27
0 countries
N/A
Brief Summary
This study comprised a randomized cross-over trial of ventilation using the NuMask Intraoral Mask versus conventional Bag Valve Mask in a cadaver model among United States Army combat medics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Sep 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 28, 2015
CompletedFirst Posted
Study publicly available on registry
December 10, 2015
CompletedResults Posted
Study results publicly available
July 22, 2016
CompletedAugust 24, 2016
July 1, 2016
1.2 years
November 28, 2015
May 1, 2016
July 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Received Minute Volume (Liters) as Measured by Wright Respirometer
An Impact 731 Ventilator will be attached to a mask. Subjects will hold a mask seal on a cadaver for 100 seconds. The Impact 731 Ventilator will then deliver standardized tidal volumes of 750 cc (delivered tidal volume) 10 times at six second intervals. A Wright respirometer will then measure received tidal volume for each of these 10 breaths.
1 Minute
Study Arms (2)
NuMask Intraoral Airway Device
EXPERIMENTALA United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each.
Bag Valve Mask
ACTIVE COMPARATORA United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each.
Interventions
Eligibility Criteria
You may qualify if:
- United States Army Combat Medics
You may not qualify if:
- Injuries precluding performance of bag valve mask ventilation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Michael D. April
- Organization
- San Antonio Military Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Program Director for Research, DEM
Study Record Dates
First Submitted
November 28, 2015
First Posted
December 10, 2015
Study Start
September 1, 2014
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
August 24, 2016
Results First Posted
July 22, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share