NuMask Versus Traditional Mask Ventilation During Routine Care
A Comparison of Controlled Ventilation With the NuMask vs. Traditional Mask Ventilation.
1 other identifier
observational
44
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2011
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 17, 2016
CompletedFirst Posted
Study publicly available on registry
July 11, 2016
CompletedMay 9, 2017
May 1, 2017
2.7 years
June 17, 2016
May 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Tidal Volume comparison
Tidal volumes delivered between the two devices will be compared
2 minutes (one minute for NuMask, one minute for traditional mask)
Secondary Outcomes (1)
Ease of use
2 minutes
Study Arms (2)
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
Traditional mask
patients randomized to traditional mask first will receive 10 breaths by traditional mask, followed by 10 breaths with NuMask
Interventions
The NuMask is a relatively new mask ventilation device that has been registered with the FDA and used in the United States since 2006.
A traditional air inflated facemark used to ventilate patients
Eligibility Criteria
Patients selected will be undergoing elective surgery at the University of Utah
You may qualify if:
- adults total
- ASA status I-III
- aged 18-64
- elective surgery at the University of Utah under general anesthesia
- Bearded, BMI \>35 or edentulous
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Derek Sakatalead
Related Publications (1)
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.
PMID: 2339799BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Derek Sakata, MD
University of Utah
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
June 17, 2016
First Posted
July 11, 2016
Study Start
May 1, 2011
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
May 9, 2017
Record last verified: 2017-05