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临床试验/NCT01852305
NCT01852305终止不适用

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

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 316 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
316
试验地点
2
主要终点
The average cost for obstructive sleep apnea management

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The average cost for obstructive sleep apnea management

时间窗: 30 days after surgery

The 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 events

时间窗: 30 days after surfery

The composite incidence of postoperative adverse events

次要结局

  • Number of visits to the health care professionals(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Frances Chung

Staff Anesthesiologist

University Health Network, Toronto

研究点 (2)

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