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Obstructive Sleep Apnea in Bariatric Surgical Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01852305
Recruitment Status : Active, not recruiting
First Posted : May 13, 2013
Last Update Posted : November 19, 2019
Sponsor:
Collaborators:
St. Michael's Hospital, Toronto
Toronto East General Hospital
Information provided by (Responsible Party):
Dr. Frances Chung, University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE April 29, 2013
First Posted Date  ICMJE May 13, 2013
Last Update Posted Date November 19, 2019
Study Start Date  ICMJE April 2013
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2013)
  • The average cost for obstructive sleep apnea management [ Time Frame: 30 days after surgery ]
    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 ]
    The composite incidence of postoperative adverse events
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2013)
Cost estimation [ Time Frame: 30 days after surgery ]
The primary outcomes will be the average cost for obstructive sleep apnea management during the period from the initial assessment visit to 30 days after surgery and the incidence of postoperative adverse events within 30 days.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2013)
Number of visits to the health care professionals [ Time Frame: 1 year ]
The secondary outcomes will be the number of visits to MDs, emergency and the length of hospital stay within the same period.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Obstructive Sleep Apnea in Bariatric Surgical Patients
Official Title  ICMJE Would A New Pathway Managing Obstructive Sleep Apnea in Bariatric Surgical Patients Be Safe and Cost-effective?
Brief Summary

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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Obstructive Sleep Apnea
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Other: Lab Sleep Study Group
  • 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.
    Intervention: Device: Oximetry
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 8, 2013)
316
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01852305
Other Study ID Numbers  ICMJE 27/2/2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Frances Chung, University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE
  • St. Michael's Hospital, Toronto
  • Toronto East General Hospital
Investigators  ICMJE
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
PRS Account University Health Network, Toronto
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP