Unrecognised Obstructive Sleep Apnea Study (OSA)
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ClinicalTrials.gov Identifier: NCT01494181 |
Recruitment Status
:
Completed
First Posted
: December 16, 2011
Last Update Posted
: January 29, 2018
|
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Plan of investigation:
This is an observational cohort study to determine the effect of OSA, independent of other risk factors, on postoperative vascular events. The study is conceived, designed and will be conducted, and analyzed independent to any company. There is no commercial sponsorship.
Condition or disease |
---|
Obstructive Sleep Apnea |
Study Type : | Observational |
Actual Enrollment : | 1200 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | Postoperative Vascular Events in Unrecognised Obstructive Sleep Apnea |
Study Start Date : | July 2011 |
Actual Primary Completion Date : | January 2018 |
Actual Study Completion Date : | January 2018 |

- primary outcome of this study is postoperative vascular event within 30 days after surgery [ Time Frame: 30 days ]

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Ages Eligible for Study: | 45 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients Inclusion & Exclusion Criteria:
Inclusion criteria:
Ethics Committee approval and informed consent will be obtained. We plan to study patients at moderate-to-high risk for postoperative vascular complications because our data from other trials suggested that the incidence of OSA in these patients is higher than the general population. We will include patients who are:
- adult males and females, age ≥ 45 years, undergoing elective non-cardiac surgery that is expected to require a postoperative hospital stay of more than 3 nights, and
- at increased risk for postoperative vascular events, defined as having at least one of the following risk factors (a) high-risk surgery (intra-peritoneal, intra-thoracic or supra-inguinal vascular surgery); (b) history of ischemic heart disease; (c) history of congestive heart failure; (d) history of cerebrovascular disease (d) diabetes requiring insulin therapy (e) serum creatinine > 175 µmol/L.
Exclusion criteria:
Patients will be excluded if:
- they have a previous diagnosis of OSA or any sleep-related breathing disorder and on treatment
- they are unwilling or physically unavailable for PSG on any night before surgery;
- their surgery included tonsillectomy, septoplasty, uvuloplasty, pharyngoplasty, tracheostomy, or prolonged (> 48 hrs) postoperative mechanical ventilation of the lungs is anticipated. It is because these procedures/interventions are likely to cure or at least modify the severity of OSA.

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): NCT01494181
Canada, Ontario | |
The Scarborough hospital | |
Scarborough, Ontario, Canada | |
Hong Kong | |
Prince of Wales Hospital | |
Shatin, Hong Kong | |
Malaysia | |
Unversity Malaya Medical Centre | |
Kuala Lumpur, Malaysia | |
Singapore | |
Khoo Teck Puat Hospital | |
Singapore, Singapore, 768828 |
Principal Investigator: | Frances Chung, MBBS, FRCPC | University Health Network, Toronto |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Dr. Frances Chung, Staff Anesthesiologist, University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT01494181 History of Changes |
Other Study ID Numbers: |
Version Nov 14, 2011 |
First Posted: | December 16, 2011 Key Record Dates |
Last Update Posted: | January 29, 2018 |
Last Verified: | January 2018 |
Keywords provided by Dr. Frances Chung, University Health Network, Toronto:
obstructive sleep apnea vascular events |
Additional relevant MeSH terms:
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |