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Status:

COMPLETED

Unrecognised Obstructive Sleep Apnea Study

Lead Sponsor:

University Health Network, Toronto

Conditions:

Obstructive Sleep Apnea

Eligibility:

All Genders

45+ years

Brief Summary

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 ...

Detailed Description

The potential study subjects will be approached by study coordinator at preoperative clinic. If the patient is interested in participating the study, he/she will be screened and consented. Undetected ...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    July 1 2011

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2018

    Estimated Enrollment :

    1200 Patients enrolled

    Trial Details

    Trial ID

    NCT01494181

    Start Date

    July 1 2011

    End Date

    January 1 2018

    Last Update

    January 29 2018

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    The Scarborough hospital

    Scarborough Village, Ontario, Canada

    2

    Prince of Wales Hospital

    Shatin, Hong Kong

    3

    Unversity Malaya Medical Centre

    Kuala Lumpur, Malaysia

    4

    Khoo Teck Puat Hospital

    Singapore, Singapore, 768828