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NuMask Versus Traditional Mask Ventilation During Routine Care

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02828280
Enrollment
44
Registered
2016-07-11
Start date
2011-05-31
Completion date
2014-01-31
Last updated
2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apnea

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.

Interventions

DEVICENuMask

The NuMask is a relatively new mask ventilation device that has been registered with the FDA and used in the United States since 2006.

DEVICETraditional mask

A traditional air inflated facemark used to ventilate patients

Sponsors

Derek Sakata
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Tidal Volume comparison2 minutes (one minute for NuMask, one minute for traditional mask)Tidal volumes delivered between the two devices will be compared

Secondary

MeasureTime frameDescription
Ease of use2 minutesProvider will rate each device for ease of use on a 1-5 scale with 1 being easy and 5 being difficult.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026