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