Obstructive Sleep Apnea in Bariatric Surgical Patients

NCT ID: NCT01852305

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 316 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2021-04-30

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lab Sleep Study Group

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Oximetry

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: OTHER

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

Intervention Type: DEVICE

Other Intervention Names

Lab polysomnography study; oximeter/group 2

Eligibility Criteria

Exclusion Criteria

• 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. -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: collaborator

Michael Garron Hospital

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Dr. Frances Chung

Staff Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frances Chung, MBBS FRCPC

Role: PRINCIPAL_INVESTIGATOR

University Health Network,University of Toronto

David Mazer, MD

Role: PRINCIPAL_INVESTIGATOR

St. Michael's Hospital, University of Toronto

James Kulchyk, MD

Role: PRINCIPAL_INVESTIGATOR

Toronto East General Hospital, University of Toronto

Locations

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

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

27/2/2013

Identifier Type: -

Identifier Source: org_study_id