Unrecognised Obstructive Sleep Apnea Study (OSA)

This study is currently recruiting participants.
Verified July 2011 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
Dr. Frances Chung, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01494181
First received: December 12, 2011
Last updated: December 17, 2013
Last verified: July 2011
  Purpose

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
Obstructive Sleep Apnea

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Postoperative Vascular Events in Unrecognised Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • primary outcome of this study is postoperative vascular event within 30 days after surgery [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: July 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Surgical patient

Criteria

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:

  1. 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
  2. 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:

  1. they have a previous diagnosis of OSA or any sleep-related breathing disorder and on treatment
  2. they are unwilling or physically unavailable for PSG on any night before surgery;
  3. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494181

Contacts
Contact: Dr. Frances Chung, MBBS, FRCPC 4166035800 ext 5433 frances.chung@uhn.on.ca
Contact: Sohail Iqbal, MD 4167908307 sohail.iqbal@uhn.on.ca

Locations
Canada, Ontario
The Scarborough hospital Recruiting
Scarborough, Ontario, Canada
Contact: Stanley Tam, MD       stanley.tam@hotmail.com   
Contact: Sohail Iqbal    4167908307    sohail.iqbal@uhn.on.ca   
Sub-Investigator: Stanley Tam, MD         
Hong Kong
Prince of Wales Hospital Recruiting
Shatin, Hong Kong
Contact: Matthew Chan, MBBS    +85226322736    mtvchan@cuhk.edu.hk   
Principal Investigator: Matthew Chan, MBBS         
Malaysia
Unversity Malaya Medical Centre Recruiting
Kuala Lumpur, Malaysia
Contact: Wang Chew Yin, MBChB, FRCA    60379492050    wangcy1836@gmail.com   
Sub-Investigator: Wang Chew Yin, MBChB         
Singapore
Khoo Teck Puat Hospital Not yet recruiting
Yishun, Singapore, 768828
Contact: Edwin Seet Cheu Ping, MBBS    65-66022317    seetedwin@gmail.com   
Sub-Investigator: Edwin Seet, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Frances Chung, MBBS, FRCPC University Health Network, Toronto
  More Information

No publications provided

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
Study First Received: December 12, 2011
Last Updated: December 17, 2013
Health Authority: Canada: Health Canada

Keywords provided by 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 Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 15, 2014