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Obstructive Sleep Apnea in Bariatric Surgical Patients

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01852305
Enrollment
316
Registered
2013-05-13
Start date
2013-04-30
Completion date
2021-04-30
Last updated
2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

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

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.

Interventions

OTHERLab 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.

DEVICEOximetry

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

Unity Health Toronto
CollaboratorOTHER
Michael Garron Hospital
CollaboratorOTHER
University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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. -

Design outcomes

Primary

MeasureTime frameDescription
The average cost for obstructive sleep apnea management30 days after surgeryThe average cost for obstructive sleep apnea management during the period from the initial assessment visit to 30 days after surgery.
The incidence of postoperative adverse events30 days after surferyThe composite incidence of postoperative adverse events

Secondary

MeasureTime frameDescription
Number of visits to the health care professionals1 yearThe secondary outcomes will be the number of visits to MDs, emergency and the length of hospital stay within the same period.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026