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OpenTrials
Completed

NCT Number: NCT02828280

NuMask Versus Traditional Mask Ventilation During Routine Care

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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Key information

Conditions

Apnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NuMask

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

Device

A traditional air inflated facemark used to ventilate patients

Primary outcomes

  1. Tidal Volume comparison

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

    Tidal volumes delivered between the two devices will be compared

Secondary outcomes

  1. Ease of use

    Time frame: 2 minutes

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

Sponsors and collaborators

Lead sponsor

Derek Sakata

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 11, 2016
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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