NuMask Versus Traditional Mask Ventilation During Routine Care

A Comparison of Controlled Ventilation With the NuMask vs. Traditional Mask Ventilation.

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.

Study Overview

• Status: Completed
• Conditions: Apnea
• Intervention / Treatment: Device: NuMask; Device: Traditional mask

• Study Type: Observational
• Enrollment (Actual): 44

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients selected will be undergoing elective surgery at the University of Utah

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: NuMask; The NuMask is a relatively new mask ventilation device that has been registered with the FDA and used in the United States since 2006.; Device: Traditional mask; A traditional air inflated facemark used to ventilate patients
Traditional mask; patients randomized to traditional mask first will receive 10 breaths by traditional mask, followed by 10 breaths with NuMask	Device: NuMask; The NuMask is a relatively new mask ventilation device that has been registered with the FDA and used in the United States since 2006.; Device: Traditional mask; A traditional air inflated facemark used to ventilate patients

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Derek Sakata
• Investigators: Principal Investigator: Derek Sakata, MD, University of Utah

Publications and helpful links

General Publications

• Caplan RA, Posner KL, Ward RJ, Cheney FW. Adverse respiratory events in anesthesia: a closed claims analysis. Anesthesiology. 1990 May;72(5):828-33. doi: 10.1097/00000542-199005000-00010.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ACTUAL): January 1, 2014

Study Registration Dates

• First Submitted: June 17, 2016
• First Submitted That Met QC Criteria: July 6, 2016
• First Posted (ESTIMATE): July 11, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 6, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: IRB_00042299

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes