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Obstructive Sleep ApneaOSANCT01494181

Unrecognised Obstructive Sleep Apnea Study

An observational study of Obstructive Sleep Apnea, run by University Health Network, Toronto at 4 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 will be conducted, and analyzed independent to any company. There is no commercial sponsorship. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Obstructive Sleep Apnea
How many people
1,200 participants
Where
4 sitesin 4 countries
Study dates
Jul 2011to Jan 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Surgical patient

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 4 countries.

4 sites in 4 countries

Canada1 site

  • The Scarborough hospital

    Scarborough Village, Ontario

Other trials in Canada

Hong Kong1 site

  • Prince of Wales Hospital

    Shatin

Other trials in Hong Kong

Malaysia1 site

  • Unversity Malaya Medical Centre

    Kuala Lumpur

Other trials in Malaysia

Singapore1 site

  • Khoo Teck Puat Hospital

    Singapore, 768828

Other trials in Singapore

About this study

Official title: Postoperative Vascular Events in Unrecognised Obstructive Sleep Apnea

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.

Read the 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 or untreated OSA will be established by STOP-Bang questionnaire and subsequent overnight PSG by using Apnea Link Plus which is level ( 2 ) at patient's home.The following data will be recorded: including age, gender, history of coronary artery disease, prior revascularization, cerebrovascular disease, peripheral vascular disease, critical aortic valvular stenosis, congestive heart failure, atrial fibrillation, diabetes treated with insulin or an oral diabetic drug, hypertension, hypercholesterolemia treated with drug therapy, tobacco use, renal insufficiency and the type of surgery. For all study patients, the nocturnal blood oxygen saturation will be monitored by a pulse oximeter (PULSOX 300i) for first 3 nights postoperatively.During their stay in hospital, patients will be followed daily, and outcomes will be recorded, until discharge.. ECG will be measured preoperatively and repeated on day 1 to 3 after surgery. Venous blood will be collected 6-12 hours and on the first 3 days after surgery for measuring cTnT concentration.If patient's ECG is abnormal and/or patient is positive for troponin test, treating physician will be contacted for further treatment. Patient will be contacted 30 days after surgery by phone to ascertain if they have experienced any adverse out come.

Keywords
obstructive sleep apnea, vascular events
Medical subject headings
Sleep Apnea, Obstructive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. primary outcome of this study is postoperative vascular event within 30 days after surgery

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionJan 2018
  4. Study completionJan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
1,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01494181
Sponsor's protocol ID
Version Nov 14, 2011
Acronym
OSA
Status last verified
Jan 2018
First submitted
12 Dec 2011
Last updated
29 Jan 2018
Results posted
No
Data monitoring committee
No

Publications

  • Chung F, Waseem R, Wang CY, Seet E, Suen C, Chan MTV; Postoperative Vascular Complications in Unrecognised Obstructive Sleep Apnea (POSA) Study Investigators. Preoperative oximetry-derived hypoxemia predicts postoperative cardiovascular events in surgical patients with unrecognized obstructive sleep apnea. J Clin Anesth. 2022 Jun;78:110653. doi: 10.1016/j.jclinane.2022.110653. Epub 2022 Feb 4.

    PubMed 35131555

  • Seet E, Chung F, Wang CY, Tam S, Kumar CM, Ubeynarayana CU, Yim CC, Chew EFF, Lam CKM, Cheng BCP, Chan MTV. Association of Obstructive Sleep Apnea With Difficult Intubation: Prospective Multicenter Observational Cohort Study. Anesth Analg. 2021 Jul 1;133(1):196-204. doi: 10.1213/ANE.0000000000005479.

    PubMed 33720906

  • Waseem R, Chan MTV, Wang CY, Seet E, Tam S, Loo SY, Lam CKM, Hui DS, Chung F. Diagnostic performance of the STOP-Bang questionnaire as a screening tool for obstructive sleep apnea in different ethnic groups. J Clin Sleep Med. 2021 Mar 1;17(3):521-532. doi: 10.5664/jcsm.8940.

    PubMed 33112227

  • Chan MT, Wang CY, Seet E, Tam S, Lai HY, Walker S, Short TG, Halliwell R, Chung F; POSA Investigators. Postoperative vascular complications in unrecognised Obstructive Sleep apnoea (POSA) study protocol: an observational cohort study in moderate-to-high risk patients undergoing non-cardiac surgery. BMJ Open. 2014 Jan 9;4(1):e004097. doi: 10.1136/bmjopen-2013-004097.

    PubMed 24413351

Questions about this trial

What is this clinical trial studying?

An observational study of Obstructive Sleep Apnea, run by University Health Network, Toronto at 4 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada, Hong Kong, Malaysia, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

primary outcome of this study is postoperative vascular event within 30 days after surgery (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01494181, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2018.

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Unrecognised Obstructive Sleep Apnea Study | AzTrials