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

Brooke Army Medical Center

Status and phase: Completed; Phase 4

Conditions: Apnea

Treatments: Device: NuMask Intraoral Airway Device; Device: Bag Valve Mask

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02627001

C.2014.134e

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• United States Army Combat Medics

Exclusion criteria

• Injuries precluding performance of bag valve mask ventilation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

NuMask Intraoral Airway Device

Experimental group

Description:

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.

Treatment:

Device: NuMask Intraoral Airway Device

Bag Valve Mask

Active Comparator group

Description:

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.

Treatment:

Device: Bag Valve Mask