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Obstructive Sleep Apnea in Bariatric Surgical Patients

Primary Purpose

Obstructive Sleep Apnea

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lab Sleep Study Group
Oximetry
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, Continuous positive airway pressure (CPAP), Oximetry, Bariatric Surgery, Anesthesia, Oxygen desaturation index (ODI)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

  • 399 Bathurst St.,Toronto Western Hopsital, Preadmission Clinic, Dept. of Anesthesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lab Sleep Study (group 1)

Oximetry group (group 2)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The average cost for obstructive sleep apnea management
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
The composite incidence of postoperative adverse events

Secondary Outcome Measures

Number of visits to the health care professionals
The secondary outcomes will be the number of visits to MDs, emergency and the length of hospital stay within the same period.

Full Information

First Posted
April 29, 2013
Last Updated
April 26, 2021
Sponsor
University Health Network, Toronto
Collaborators
Unity Health Toronto, Michael Garron Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01852305
Brief Title
Obstructive Sleep Apnea in Bariatric Surgical Patients
Official Title
Would A New Pathway Managing Obstructive Sleep Apnea in Bariatric Surgical Patients Be Safe and Cost-effective?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
due to lack resources
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2021 (Actual)
Study Completion Date
April 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
Collaborators
Unity Health Toronto, Michael Garron Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive sleep apnea, Continuous positive airway pressure (CPAP), Oximetry, Bariatric Surgery, Anesthesia, Oxygen desaturation index (ODI)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
316 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lab Sleep Study (group 1)
Arm Type
Experimental
Arm Description
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.
Arm Title
Oximetry group (group 2)
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Lab Sleep Study Group
Other Intervention Name(s)
Lab polysomnography study
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Oximetry
Other Intervention Name(s)
oximeter/group 2
Intervention Description
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
Primary Outcome Measure Information:
Title
The average cost for obstructive sleep apnea management
Description
The average cost for obstructive sleep apnea management during the period from the initial assessment visit to 30 days after surgery.
Time Frame
30 days after surgery
Title
The incidence of postoperative adverse events
Description
The composite incidence of postoperative adverse events
Time Frame
30 days after surfery
Secondary Outcome Measure Information:
Title
Number of visits to the health care professionals
Description
The secondary outcomes will be the number of visits to MDs, emergency and the length of hospital stay within the same period.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: Unable or not willing to give an informed consent; Potential problems with EEG; Patients with diagnosed OSA. Patients having sleep study before. Age: < 18 years having sleep study before. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frances Chung, MBBS FRCPC
Organizational Affiliation
University Health Network,University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Mazer, MD
Organizational Affiliation
St. Michael's Hospital, University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Kulchyk, MD
Organizational Affiliation
Toronto East General Hospital, University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
399 Bathurst St.,Toronto Western Hopsital, Preadmission Clinic, Dept. of Anesthesia
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada

12. IPD Sharing Statement

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Obstructive Sleep Apnea in Bariatric Surgical Patients

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