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Novel Technique for Face Mask Ventilation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01946464
Recruitment Status : Terminated
First Posted : September 19, 2013
Last Update Posted : December 26, 2016
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

Brief Summary:
This study is being done to see if we can improve the way we manage patients' airways. In some instances patients who have a beard, who do not have teeth or have breathing problems during sleep present a challenge to the anesthesiologist. In such patients, it is sometimes difficult to provide air/oxygen for breathing using a mask. The study doctors would like to investigate a new method for holding a mask on the face of those patients. They are interested in comparing a new method against two older methods. They believe the new method will deliver a larger amount of air to the lungs. This information may help doctors provide better care for patients who have beards, no teeth, or breathing problems during sleep.

Condition or disease
Obstructive Sleep Apnea

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Study Type : Observational
Actual Enrollment : 30 participants
Time Perspective: Prospective
Official Title: Novel Technique for Face Mask Ventilation
Study Start Date : September 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

undergoing surgery with general anesthesia
pts: edentulous, bearded, obstructive sleep apnea, Mallampati Class III or IV
Mallampati I and II
Control group Mallampati I visualization of tonsils, uvula and soft palate Mallampati II visualization of hard and soft palate, and upper portion of tonsils and uvula.

Primary Outcome Measures :
  1. tidal volume [ Time Frame: at induction ]
    The primary aim of this study is to determine if using the novel one hand approach provides better ventilation as demonstrated by the tidal volumes.

Secondary Outcome Measures :
  1. ventilation technique [ Time Frame: at induction ]
    The secondary aim is to analyze the anesthesia providers' ability to ventilate using all three techniques based on their individual gender, grip strength, hand size and age range

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
pts coming to Same Day Surgery who require anesthesia

Inclusion Criteria:

  • undergoing general anesthesia
  • no longer have your own teeth
  • have a beard
  • have obstructive sleep apnea
  • ASA score of 1, 2,3
  • BMI<45
  • Mallampati I, II. II or IV -(nil per os) Nothing taken orally for 8 hours-

Exclusion Criteria:

  • ASA 4
  • Morbidly obese >45
  • Loose teeth
  • cervical neck instability
  • history of difficult airway
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01946464

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United States, New Jersey
Rutgers RBHS Newark -DOC
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
Rutgers, The State University of New Jersey
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Principal Investigator: Dennis Grech, MD Rutgers/NJMS
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Responsible Party: Rutgers, The State University of New Jersey Identifier: NCT01946464    
Other Study ID Numbers: 2012001161
First Posted: September 19, 2013    Key Record Dates
Last Update Posted: December 26, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rutgers, The State University of New Jersey:
general anesthesia
Mallampati Class II or IV
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases