NuMask Versus Traditional Mask Ventilation During Routine Care

Completed

• Conditions: Apnea
• Interventions: Device: NuMask; Device: Traditional mask

• Registration Number: NCT02828280
• Lead Sponsor: Derek Sakata

Brief Summary

The direct objective of this study is to determine whether an experienced provider can more adequately and/or easily ventilate an anesthetized patient with the NuMask device as compared to traditional bag-valve-mask ventilation. These are approved masks, being used in the patients routine care. The researchers believe that mean tidal volumes obtained by experienced providers when manually ventilating anesthetized patients with the NuMask device will be larger than when using the traditional bag-valve-mask.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Study First Submitted: 2016-06-17
• Study First Submitted QC: 2016-07-06
• Study First Posted: 2016-07-11
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-06
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• 44 adults total
• ASA status I-III
• aged 18-64
• elective surgery at the University of Utah under general anesthesia
• Bearded, BMI >35 or edentulous

Exclusion Criteria

• ASA IV or higher
• Oropharyngeal or facial pathology
• Risk of aspiration (defined by need for rapid sequence intubation, uncontrolled gastroesophageal reflux disease)
• Known and/or documented difficulty placing an endotracheal tube in the past
• Limited neck extension or flexion
• Personal or familial history of malignant hyperthermia
• Known or predicted severe respiratory disease or compromise
• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NuMask	NuMask	Pt's randomized to Numask first will be ventilated for 10 breaths with the NuMask device first, followed by 10 breaths with the traditional face mask
NuMask	Traditional mask	Pt's randomized to Numask first will be ventilated for 10 breaths with the NuMask device first, followed by 10 breaths with the traditional face mask
Traditional mask	NuMask	patients randomized to traditional mask first will receive 10 breaths by traditional mask, followed by 10 breaths with NuMask
Traditional mask	Traditional mask	patients randomized to traditional mask first will receive 10 breaths by traditional mask, followed by 10 breaths with NuMask

Primary Outcome Measures

Name	Time	Method
Tidal Volume comparison	2 minutes (one minute for NuMask, one minute for traditional mask)	Tidal volumes delivered between the two devices will be compared

Secondary Outcome Measures

Name	Time	Method
Ease of use	2 minutes	Provider will rate each device for ease of use on a 1-5 scale with 1 being easy and 5 being difficult.