Obstructive Sleep Apnea in Bariatric Surgical Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University Health Network, Toronto
Sponsor:
Collaborators:
St. Michael's Hospital, Toronto
Toronto East General Hospital
Information provided by (Responsible Party):
Dr. Frances Chung, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01852305
First received: April 29, 2013
Last updated: December 17, 2013
Last verified: November 2013
  Purpose

Purpose:

The purpose of this study is to develop a novel pathway to decrease the cost and waiting time to manage bariatric surgical patients with obstructive sleep apnea.

Hypotheses:

Compared to the current perioperative pathway, the proposed novel pathway incorporating overnight oximetry and perioperative sleep apnea precautions is safe and more cost effective for evaluating and managing obstructive sleep apnea in the bariatric surgical patients.

To decrease the cost and waiting time, we proposed a novel perioperative pathway to manage obstructive sleep apnea in the bariatric patients. In this pathway, the patient will be screened by the STOP-Bang questionnaire. The recruited patients will be randomized into two groups:

The STOP-Bang questionnaire score is ≥4 then you will be assigned to any one of these groups

  • sleep study group (group 1) or
  • oximetry group (group 2).

Condition Intervention
Obstructive Sleep Apnea
Other: Lab Sleep Study Group
Device: Oximetry

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Would A New Pathway Managing Obstructive Sleep Apnea in Bariatric Surgical Patients Be Safe and Cost-effective?

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The average cost for obstructive sleep apnea management [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]
    The average cost for obstructive sleep apnea management during the period from the initial assessment visit to 30 days after surgery.

  • The incidence of postoperative adverse events [ Time Frame: 30 days after surfery ] [ Designated as safety issue: No ]
    The composite incidence of postoperative adverse events


Secondary Outcome Measures:
  • Number of visits to the health care professionals [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The secondary outcomes will be the number of visits to MDs, emergency and the length of hospital stay within the same period.


Estimated Enrollment: 316
Study Start Date: April 2013
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lab Sleep Study (group 1)
The patients in the Sleep Study group will be referred to a sleep medicine specialist who is part of the Bariatric Surgery Psychosocial Program. In the Sleep Study group, patients will undergo sleep studies overnight in a sleep laboratory. At the same time, they will also wear the oximeter wristwatch to measure overnight oximetry.
Other: Lab Sleep Study Group
Patients in this group will under go lab sleep study overnight at the sleep clinic.If the patient has severe sleep apnea (AHI>30) or moderate sleep apnea (AHI>15 to <30) with significant co-morbidities (e.g. cardiovascular disease, diabetes), CPAP treatment will be recommended. For mild sleep apnea (AHI>5 to <15) or moderate sleep apnea without significant co-morbidities, CPAP will not be required. If patient is not able to tolerate or refuses CPAP, dental device and positional therapy will be recommended.
Other Name: Lab polysomnography study
Active Comparator: Oximetry group (group 2)
The patients in the Oximetry group will undergo overnight pulse oximetry. The patients with ODI>10 events/hour will be referred to the sleep medicine specialist.A split- night polysomnography(PSG) will be employed to confirm obstructive sleep apnea OSA) diagnosis. The 1st part of the night will be a sleep study and depending on AHI, CPAP titration will be done for the 2nd part of the night.
Device: Oximetry
The patients in the Oximetry group will undergo overnight pulse oximetry. The patients with ODI>10 events/hour will be referred to the sleep medicine specialist.A split- night PSG will be employed to confirm OSA diagnosis. The 1st part of the night will be a sleep study and depending on AHI, CPAP titration will be done for the 2nd part of the night
Other Name: oximeter/group 2

Detailed Description:

The potential patients will be screened by the STOP-Bang questionnaire. Those with a score ≥4 will be randomized into Sleep Study group or Oximetry group. The patients in the Sleep Study group will be referred to a sleep medicine specialist who is part of the Bariatric Surgery Psychosocial Program. In the Sleep Study group, patients will undergo sleep studies overnight in a sleep laboratory. At the same time, they will also wear the oximeter wristwatch to measure overnight oximetry. Depending on the sleep study results and medical history, a decision will be made regarding therapeutic options. If the patient has severe sleep apnea (AHI>30) or moderate sleep apnea (AHI>15 to <30) with significant co-morbidities (e.g. cardiovascular disease, diabetes), CPAP treatment will be recommended. For mild sleep apnea (AHI>5 to <15) or moderate sleep apnea without significant co-morbidities, CPAP will not be required. If patient is not able to tolerate or refuses CPAP, dental device and positional therapy will be recommended.

The patients in the Oximetry group will undergo overnight pulse oximetry. The patients with ODI>10 events/hour will be referred to the sleep medicine specialist. Since the patients with ODI>10 had a high probability 69%) to have moderate and severe OSA. A split- night PSG will be employed to confirm OSA diagnosis and to titrate CPAP with in patients with ODI>10. The 1st part of the night will be a sleep study and depending on AHI, CPAP titration will be done for the 2nd part of the night. Compared to Sleep Study group, only one night instead of two nights of sleep studies is needed in patients with ODI>10 events/hour. The patients with ODI ≤ 10 events/h will undergo surgery with routine care plus sleep apnea perioperative precautions.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion/Exclusion criteria: The patients who meet the following criteria will be recruited.

  • Patients undergoing bariatric surgery with American Society of Anaesthesiologists (ASA) score 1-4 will be approached.
  • The patients with any of the following conditions will be excluded:

    1. Unable or not willing to give an informed consent;
    2. Potential problems with EEG;
    3. Patients with diagnosed OSA.
    4. Patients having sleep study before.
    5. Age: < 18 years having sleep study before. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01852305

Contacts
Contact: Sazzadul Islam, M.Sc 4166035800 ext 2246 sazzadul.islam@uhn.ca
Contact: Peter Liao, MBBS 4166035800 ext 2508 peter.liao@uhn.ca

Locations
Canada, Ontario
399 Bathurst St.,Toronto Western Hopsital, Preadmission Clinic, Dept. of Anesthesia Recruiting
Toronto, Ontario, Canada, M5T2S8
Contact: Sazzadul Islam, M.Sc.    4166035800 ext 2246    sazzadul.islam@uhn.ca   
Contact: Peter Liao, MBBS    4166035800 ext 2508    peter.liao@uhn.ca   
Principal Investigator: Frances Chung, MBBS FRCPC         
Sponsors and Collaborators
University Health Network, Toronto
St. Michael's Hospital, Toronto
Toronto East General Hospital
Investigators
Principal Investigator: Frances Chung, MBBS FRCPC University Health Network,University of Toronto
Principal Investigator: David Mazer, MD St. Michael's Hospital, University of Toronto
Principal Investigator: James Kulchyk, MD Toronto East General Hospital, University of Toronto
  More Information

No publications provided

Responsible Party: Dr. Frances Chung, Staff Anesthesiologist, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01852305     History of Changes
Other Study ID Numbers: 27/2/2013
Study First Received: April 29, 2013
Last Updated: December 17, 2013
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Obstructive sleep apnea
Continuous positive airway pressure (CPAP)
Oximetry
Bariatric Surgery
Anesthesia
Oxygen desaturation index (ODI)

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 July 23, 2014