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临床试验/NCT02980770
NCT02980770Unknown不适用

Postoperative Complications in Patients With Obesity Hypoventilation Syndrome Based on Base Excess- OHBE Study: A National, Multicenter, Observational Cohort Study

Marmara University1 个研究点 分布在 1 个国家目标入组 999 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
999
试验地点
1
主要终点
Postoperative complications

研究概览

简要总结

Obstructive sleep apnea (OSA) and Obesity-Hypoventilation Syndrome (OHS) are common conditions in obesity, which may influence the prognosis in patients undergoing surgery. There is a need for simple screening tools to identify such patients at high risk. The current multicenter observational study aims to investigate occurrence of OSA and OHS in obese individuals undergoing elective abdominal surgery and further address its impact on perioperative and postoperative complications.

详细描述

Obstructive sleep apnea (OSA) and Obesity-Hypoventilation Syndrome (OHS) are common conditions in obesity, which may influence the prognosis in patients undergoing surgery. There is a need for simple screening tools to identify such patients at high risk. The current multicenter observational study aims to investigate occurrence of OSA and OHS in obese individuals undergoing elective abdominal surgery by using questionnaires (STOPBANG questionnaire, Berlin Questionnaire, and Epworth Sleepiness Scale) and arterial blood gases. Perioperative and 72-h postoperative complications will be documented.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing elective abdominal surgery
  • Body-Mass-Index >=30 kg/m2
  • Ability to read and speak
  • Signed informed consent.

排除标准

  • Use of diuretics
  • Use of theophylline
  • Use of respiratory depressing drugs
  • Severe lung disease (FEV1/FVC<%50)
  • Severe hearth failure (EF<%35)
  • Central nervous system or muscle disease
  • Untreated hypothyroidism
  • Renal failure (GFR<50)
  • Total parenteral nutrition more than 72 hours
  • Hypokalemia
  • Hyponatremia
  • Hypomagnesemia
  • Hypoalbuminemia
  • Known sleep apnea or obesity hypoventilation syndrome
  • Blood transfusion from blood bank within 72 hours prior to surgery

结局指标

主要结局

Postoperative complications

时间窗: 72 hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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