NCT02627001

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Brooke Army Medical Center · Federal
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Apnea

Interventions

Type	Name	Description
DEVICE	NuMask Intraoral Airway Device	NuMask Intraoral Airway Device
DEVICE	Bag Valve Mask	Conventional bag valve mask

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2015-12-10
• Last updated: 2016-08-24
• Results posted: 2016-07-22