Obstructive Sleep Apnea in Bariatric Surgical Patients

NCT01852305 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2021-04-28

No results posted yet for this study

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).

Conditions

Interventions

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.

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

Sponsors & Collaborators

  • Unity Health Toronto

    collaborator OTHER
  • Michael Garron Hospital

    collaborator OTHER
  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Frances Chung, MBBS FRCPC · University Health Network,University of Toronto

  • David Mazer, MD · St. Michael's Hospital, University of Toronto

  • James Kulchyk, MD · Toronto East General Hospital, University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01852305 on ClinicalTrials.gov