Obstructive Sleep Apnea Airway Evaluation

Sponsor
University Health Network, Toronto (Other)
Overall Status
Unknown status
CT.gov ID
NCT03361553
Collaborator
Hospital for Special Surgery, New York (Other)
200
1
35.4
5.7

Study Details

Study Description

Brief Summary

Current practice guidelines recommend obstructive sleep apnea (OSA) patients to stay in the post anesthetic care unit (PACU) until the risk of respiratory depression has subsided. Inevitably, a greater demand on hospital resource utilization in these patients will increase health care cost. Polysomnography (PSG) and screening questionnaires can identify OSA but they are limited by accessibility and false positive results, respectively. Inaccurate OSA identification misguides postoperative surveillance plan. In contrast with MRI and CT scans, ultrasound is more accessible and more likely a practical tool for OSA screening. However, before clinical application, airway ultrasound (US) exam must undergo vigorous testing to check its utility, accuracy, inter-observer reliability and its ability to identify OSA and its severity.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The investigators plan to recruit surgical patients at risk of OSA, exposed to sedatives,and/or general anesthesia. Surface ultrasound measurements will be conducted in a separate setting, and be correlated with the sleep study results, and a set of ultrasound parameters will be validated in this setting. Relevant clinical outcomes will be captured as well.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Developing a Novel Clinical Tool to Evaluate Obstructive Sleep Apnea (OSA) With Airway Ultrasound
    Actual Study Start Date :
    Jul 20, 2017
    Anticipated Primary Completion Date :
    Apr 1, 2020
    Anticipated Study Completion Date :
    Jul 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Correlation of airway parameter measurements with Apnea-Hypopnea Index (AHI) values on Polysomnography (PSG) [2 years]

      Airway parameters will be measured and correlated with sleep apnea severity as indicated by AHI values obtained from PSG test

    Secondary Outcome Measures

    1. Feasibility of airway Ultrasound (US) examination; [2 years]

      Time required to do an ultrasound scan of the airway and consistency of airway parameter measurements will be assessed

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age>=18 American Society of Anesthesiologists (ASA) Physical System Classification 1-4 Suspected OSA / STOP-Bang questionnaire score for sleep apnea > 3 Referred for PSG / Had sleep study in past 1 year (amendment authorized 20/12/2017)
    Exclusion Criteria:
    • • failure to understand and provide consent

    • past history of oral, head and neck surgery (e.g., OSA corrective surgery)

    • active head & neck disease (e.g., cancer, infection and radiotherapy);

    • inability to perform breathing tests per instruction / on OSA treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Toronto Western Hospital Toronto Ontario Canada

    Sponsors and Collaborators

    • University Health Network, Toronto
    • Hospital for Special Surgery, New York

    Investigators

    • Principal Investigator: Mandeep Singh, Department of Anesthesia, Toronto Western Hospital- UHN, University of Toronto

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT03361553
    Other Study ID Numbers:
    • 16-6160
    First Posted:
    Dec 5, 2017
    Last Update Posted:
    Feb 17, 2020
    Last Verified:
    Apr 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 17, 2020