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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Apnea

Intervention / Treatment
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* Device: NuMask Intraoral Airway Device
* Device: Bag Valve Mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: United States Army Combat Medics Exclusion Criteria: Injuries precluding performance of bag valve mask ventilation
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NuMask Intraoral Airway Device<br>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. | Device: NuMask Intraoral Airway Device<br>* NuMask Intraoral Airway Device<br>|
| Active Comparator: Bag Valve Mask<br>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. | Device: Bag Valve Mask<br>* Conventional bag valve mask<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Received Minute Volume (Liters) as Measured by Wright Respirometer | 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. | 1 Minute |