CClinicalTrials.gg
CompletedNCT02828280Updated May 9, 2017

NuMask Versus Traditional Mask Ventilation During Routine Care

An observational study in Apnea, sponsored by Derek Sakata. Completed. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-09.

Sponsored by Derek Sakata · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
44
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Apnea
03

In context

Lead sponsor

This is the only study on the registry with Derek Sakata as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
44 participants (actual)
Patient registry
No

Groups and cohorts

  • 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 · Device: Traditional mask

  • Traditional mask

    patients randomized to traditional mask first will receive 10 breaths by traditional mask, followed by 10 breaths with NuMask

    Device: NuMask · Device: Traditional 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

06

What researchers measure

Primary outcomes

  1. Tidal Volume comparison

    Tidal volumes delivered between the two devices will be compared

    Time frame: 2 minutes (one minute for NuMask, one minute for traditional mask)

Secondary outcomes

  1. 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.

    Time frame: 2 minutes

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 2339799 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02828280
Lead sponsor
Derek Sakata
Responsible party
Derek Sakata (M.D., University of Utah) — Sponsor-investigator
First posted
Jul 11, 2016
Start date
May 2011
Primary completion
Jan 2014
Completion
Jan 2014
Last update
May 9, 2017

Study contacts

Derek Sakata, MD
principal investigator · University of Utah

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion