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

Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627001
• Other study ID #: 402438-1
• Status: Completed
• Phase: Phase 4
• First received: November 28, 2015
• Last updated: December 9, 2015
• Start date: September 2014
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• United States Army Combat Medics

Exclusion Criteria:

• Injuries precluding performance of bag valve mask ventilation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea

Intervention

Device:
• NuMask Intraoral Airway Device
NuMask Intraoral Airway Device
• Bag Valve Mask
Conventional bag valve mask

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean difference between delivered tidal volume (cc) and received tidal volume (cc) 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 delivered tidal volume for each of these 10 breaths. Means for the differences between the delivered and received tidal volumes will then be calculated.	1 Minute	No