Obstructive Sleep Apnea Airway Evaluation
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| ClinicalTrials.gov Identifier: NCT03361553 |
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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
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Sponsor:
University Health Network, Toronto
Collaborator:
Hospital for Special Surgery, New York
Information provided by (Responsible Party):
University Health Network, Toronto
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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 |
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| Obstructive Sleep Apnea |
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 |
| 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 Genetics related topics:
Obstructive sleep apnea
MedlinePlus related topics:
Sleep Apnea
Primary Outcome Measures :
- 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 :
- 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)
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:
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• 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 ClinicalTrials.gov identifier (NCT number): NCT03361553
Contacts
| Contact: Mandeep Singh, MD, FRCPC | 416-790-0808 | mandeep.singh@uhn.ca | |
| Contact: Vivek Kumar, MD | 416-603-5800 ext 3959 | vivek.kumar@uhnresearch.ca |
Locations
| Canada, Ontario | |
| Toronto Western Hospital | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Vivek Kumar, MD 416-603-5800 ext 3959 vivek.kumar@uhnresearch.ca | |
| Principal Investigator: Mandeep Singh, MD | |
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 |
| Responsible Party: | University Health Network, Toronto |
| ClinicalTrials.gov 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 |
| 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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Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases |
Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |