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

Phase 4

Completed

• Conditions: Apnea
• Interventions: Device: NuMask Intraoral Airway Device; Device: Bag Valve Mask

• Registration Number: NCT02627001
• Lead Sponsor: Brooke Army Medical Center

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 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.

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Study First Submitted: 2015-11-28
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-10
• Results First Submitted: 2016-05-01
• Results First Submitted QC: 2016-06-11
• Status Verified: 2016-07
• Results First Posted: 2016-07-22
• Last Update Submitted: 2016-07-23
• Last Update Posted: 2016-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• United States Army Combat Medics

Exclusion Criteria

• Injuries precluding performance of bag valve mask ventilation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NuMask Intraoral Airway Device	NuMask Intraoral Airway Device	A 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	Bag Valve Mask	A 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.

Primary Outcome Measures

Name	Time	Method
Received Minute Volume (Liters) as Measured by Wright Respirometer	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.