Trial Outcomes & Findings for Nu-Mask Intraoral Airway Device Versus Conventional Bag Valve Mask Ventilation Crossover Trial (NCT NCT02627001)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

27 participants

Primary outcome timeframe

1 Minute

Results posted on

2016-08-24

Participant Flow

Participant milestones

Participant milestones
Measure	NuMask Intraoral Mask First, Then Standard Bag Valve Mask 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. After a 5 minute rest period, the subject performs the same procedures using a conventional cuffed face mask. NuMask Intraoral Airway Device: NuMask Intraoral Airway Device	Standard Bag Valve Mask First, Then Numask Intraoral 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. After a 5 minute rest period, the subject performs the same procedures using an intraoral mask. Bag Valve Mask: Conventional bag valve mask
Overall Study STARTED	13	14
Overall Study COMPLETED	13	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NuMask Intraoral Mask First, Then Standard Bag Valve Mask n=13 Participants 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. The Medic then performs the same procedures using a standard bag valve mask. NuMask Intraoral Airway Device: NuMask Intraoral Airway Device	Standard Bag Valve Mask First, Then Numask Intraoral Mask n=14 Participants 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. The Medic then performs the same procedures using a Nu-Mask Intraoral Airway Device. Bag Valve Mask: Conventional bag valve mask	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	013 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	NuMask Intraoral Airway Device n=27 Participants 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. NuMask Intraoral Airway Device: NuMask Intraoral Airway Device	Bag Valve Mask n=27 Participants 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. Bag Valve Mask: Conventional bag valve mask
Received Minute Volume (Liters) as Measured by Wright Respirometer	6.8 Liters Interval 5.7 to 7.2	5.2 Liters Interval 4.4 to 6.3

Adverse Events

NuMask Intraoral Airway Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bag Valve Mask

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael D. April

San Antonio Military Medical Center

Phone: (210) 916-0808

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place