Obstructive Sleep Apnea in Bariatric Surgical Patients

NCT01852305 | Terminated

• 1 other identifier: 27/2/2013
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

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).

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea; Continuous positive airway pressure (CPAP); Oximetry; Bariatric Surgery; Anesthesia; Oxygen desaturation index (ODI)

Outcome Measures

Primary Outcomes (2)

• 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.

  30 days after surgery

• The incidence of postoperative adverse events

  The composite incidence of postoperative adverse events

  30 days after surfery

Secondary Outcomes (1)

• Number of visits to the health care professionals

  1 year

Study Arms (2)

Lab Sleep Study (group 1)

EXPERIMENTAL

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

Oximetry group (group 2)

ACTIVE COMPARATOR

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

Interventions

Lab Sleep Study Group 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.

Also known as: Lab polysomnography study

Lab Sleep Study (group 1)

Oximetry 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

Also known as: oximeter/group 2

Oximetry group (group 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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. -

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Unity Health Toronto: collaborator
• Michael Garron Hospital: collaborator

Study Sites (1)

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

Toronto, Ontario, M5T2S8, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Oximetry

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 13, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

CA (1)