Obstructive Sleep Apnea in Bariatric Surgical Patients

Would A New Pathway Managing Obstructive Sleep Apnea in Bariatric Surgical Patients Be Safe and Cost-effective?

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).

Study Overview

• Status: Terminated
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Other: Lab Sleep Study Group; Device: Oximetry

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: Interventional
• Enrollment (Actual): 316
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T2S8
      • 399 Bathurst St.,Toronto Western Hopsital, Preadmission Clinic, Dept. of Anesthesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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 Names: Lab polysomnography study
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.	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 Names: oximeter/group 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Unity Health Toronto; Michael Garron Hospital
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: April 29, 2013
• First Submitted That Met QC Criteria: May 8, 2013
• First Posted (Estimate): May 13, 2013

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Obstructive sleep apnea; Anesthesia; Bariatric Surgery; Continuous positive airway pressure (CPAP); Oximetry; Oxygen desaturation index (ODI)
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 27/2/2013