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Obstructive Sleep Apnea Airway Evaluation

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: NCT03361553
Recruitment Status : Unknown
Verified April 2019 by University Health Network, Toronto.
Recruitment status was:  Recruiting
First Posted : December 5, 2017
Last Update Posted : February 17, 2020
Hospital for Special Surgery, New York
Information provided by (Responsible Party):
University Health Network, Toronto

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
Obstructive Sleep Apnea

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.

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Study Type : Observational
Estimated 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 : July 20, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Primary Outcome Measures :
  1. Correlation of airway parameter measurements with Apnea-Hypopnea Index (AHI) values on Polysomnography (PSG) [ Time Frame: 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; [ Time Frame: 2 years ]
    Time required to do an ultrasound scan of the airway and consistency of airway parameter measurements will be assessed

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Suspected / Recently diagnosed untreated Obstructive Sleep Apnea (amendment authorized 20/12/2017)

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

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): NCT03361553

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Contact: Mandeep Singh, MD, FRCPC 416-790-0808
Contact: Vivek Kumar, MD 416-603-5800 ext 3959

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Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada
Contact: Vivek Kumar, MD    416-603-5800 ext 3959   
Principal Investigator: Mandeep Singh, MD         
Sponsors and Collaborators
University Health Network, Toronto
Hospital for Special Surgery, New York
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Principal Investigator: Mandeep Singh Department of Anesthesia, Toronto Western Hospital- UHN, University of Toronto
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Responsible Party: University Health Network, Toronto Identifier: NCT03361553    
Other Study ID Numbers: 16-6160
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases