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NuMask Versus Traditional Mask Ventilation During Routine Care

Completed
Conditions
Apnea
Registration Number
NCT02828280
Lead Sponsor
Derek Sakata
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
44
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Tidal Volume comparison2 minutes (one minute for NuMask, one minute for traditional mask)

Tidal volumes delivered between the two devices will be compared

Secondary Outcome Measures
NameTimeMethod
Ease of use2 minutes

Provider will rate each device for ease of use on a 1-5 scale with 1 being easy and 5 being difficult.

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