NuMask Versus Traditional Mask Ventilation During Routine Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Intervention Type DEVICE

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

Intervention Type DEVICE

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

NuMask

Intervention Type DEVICE

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

Intervention Type DEVICE

A traditional air inflated facemark used to ventilate patients

Interventions

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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.

Intervention Type DEVICE

Traditional mask

A traditional air inflated facemark used to ventilate patients

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes