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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03361553
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date November 14, 2017
First Posted Date December 5, 2017
Last Update Posted Date April 26, 2019
Actual Study Start Date July 20, 2017
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 28, 2017)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03361553 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 28, 2017)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Obstructive Sleep Apnea Airway Evaluation
Official Title Developing a Novel Clinical Tool to Evaluate Obstructive Sleep Apnea (OSA) With Airway Ultrasound
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Suspected / Recently diagnosed untreated Obstructive Sleep Apnea (amendment authorized 20/12/2017)
Condition Obstructive Sleep Apnea
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 28, 2017)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mandeep Singh, MD, FRCPC 416-790-0808 mandeep.singh@uhn.ca
Contact: Arvind Tuteja, MBBS 416-603-5800 ext 3959 arvind.tuteja@uhnresearch.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03361553
Other Study ID Numbers 16-6160
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor University Health Network, Toronto
Collaborators Not Provided
Investigators
Principal Investigator: Mandeep Singh Department of Anesthesia, Toronto Western Hospital- UHN, University of Toronto
PRS Account University Health Network, Toronto
Verification Date April 2019