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.

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

Apnea

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.

NuMask Intraoral Airway Device

Bag Valve Mask

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

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.

Assistant Program Director for Research, DEM

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.

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.

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?