Clinical Trial: Nu-Mask Intraoral Airway Device Versus Conventional Bag Valve Mask Ventilation Crossover Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

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.

Detailed Summary: This study comprised a randomized crossover trial of adult United States Army combat medic volunteers participating in a cadaver laboratory as part of their training. The study took place in Bulverde, TX. Participants were randomized to perform cadaver ventilation first using either the novel Nu-MaskR intraoral device or conventional bag valve mask. A one handed seal technique was used to simulate single operator ventilation. Participants were responsible for mask placement while a ventilator delivered 10 breaths each with a standardized tidal volume of 750 ml. After a 5-minute washout period, they performed ventilation using the alternative device. The primary outcome measure was air leak as calculated by subtracting tidal volume received from tidal volume delivered as measured by the ventilator.
Sponsor: Brooke Army Medical Center

Current Primary Outcome: Received Minute Volume (Liters) as Measured by Wright Respirometer [ Time Frame: 1 Minute ]

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.


Original Primary Outcome: Mean difference between delivered tidal volume (cc) and received tidal volume (cc) as measured by Wright respirometer [ Time Frame: 1 Minute ]

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 delivered tidal volume for each of these 10 breaths. Means for the differences between the delivered and received tidal volumes will then be calculated.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Brooke Army Medical Center

Dates:
Date Received: November 28, 2015
Date Started: September 2014
Date Completion:
Last Updated: July 23, 2016
Last Verified: July 2016