NuMask Versus Traditional Mask Ventilation During Routine Care

Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02828280
• Other study ID #: IRB_00042299
• Status: Completed
• Phase: N/A
• First received: June 17, 2016
• Last updated: May 6, 2017
• Start date: May 2011
• Est. completion date: January 2014

Study information

• Verified date: May 2017
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea

Intervention

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.
• Traditional mask
A traditional air inflated facemark used to ventilate patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Derek Sakata

References & Publications (1)

Caplan RA, Posner KL, Ward RJ, Cheney FW. Adverse respiratory events in anesthesia: a closed claims analysis. Anesthesiology. 1990 May;72(5):828-33. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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