Novel Technique for Face Mask Ventilation

NCT01946464 | Terminated

• 1 other identifier: 2012001161
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

edentulous; bearded; patients; requiring; general anesthesia; Mallampati Class II or IV

Outcome Measures

Primary Outcomes (1)

• tidal volume

  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.

  at induction

Secondary Outcomes (1)

• ventilation technique

  at induction

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

pts coming to Same Day Surgery who require anesthesia

You may qualify if:

• 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-

You may not qualify if:

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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers RBHS Newark -DOC

Newark, New Jersey, 07101, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Mouth, Edentulous

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Dennis Grech, MD

  Rutgers/NJMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: September 19, 2013
• Study Start: September 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 26, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)