Clinical trial NCT01852305: 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
Overall status: TERMINATED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea
Continuous positive airway pressure (CPAP)
Oximetry
Bariatric Surgery
Anesthesia
Oxygen desaturation index (ODI)
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
name: Michael Garron Hospital
First posted: 2013-05-13
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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:

  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. -

Primary outcomes:
measure: The average cost for obstructive sleep apnea management
timeFrame: 30 days after surgery
measure: The incidence of postoperative adverse events
timeFrame: 30 days after surfery
Secondary outcomes:
measure: Number of visits to the health care professionals
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: 399 Bathurst St.,Toronto Western Hopsital, Preadmission Clinic, Dept. of Anesthesia
state: Ontario
Study officials:
affiliation: University Health Network,University of Toronto
name: Frances Chung, MBBS FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Michael's Hospital, University of Toronto
name: David Mazer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toronto East General Hospital, University of Toronto
name: James Kulchyk, MD
role: PRINCIPAL_INVESTIGATOR
References: