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临床试验/NCT01476254
NCT01476254已完成不适用

Respiratory Complications After Laparoscopic Surgery

Herlev Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Arterial oxygen tension 2 hours after surgery

研究概览

简要总结

The purpose of this study is to describe the magnitude of respiratory complications after laparoscopic hysterectomy and cholecystectomy.

详细描述

The purpose of this study is to describe change in pulmonary function and incidence of respiratory complications after laparoscopic surgery.

The investigators will include 60 women scheduled for laparoscopic hysterectomy or cholecystectomy. The investigators will measure the pulmonary function by different methods during and for 2 hours after surgery. Moreover, the incidence of respiratory complications including pneumonia, respiratory failure and radiologically verified atelectasis will be registered.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • > 45 years old
  • Scheduled for laparoscopic cholecystectomy or laparoscopic hysterectomy

排除标准

  • Weight < 50 kg
  • Pregnant or nursing
  • Cardiac failure
  • Renal failure
  • Inability to breath through a facial mask
  • Inability to give informed consent
  • Inability to keep arterial oxygen saturation above 90% without supplemental oxygen

结局指标

主要结局

Arterial oxygen tension 2 hours after surgery

时间窗: 2 hours after end of surgery

Change in arterial oxygen tension 2 hours after surgery

次要结局

  • Arterial oxygen saturation 2 hours after surgery(2 hours after surgery)
  • Pneumonia(Participants will be followed for the duration of hospital stay, an expected average of 3 days)
  • Respiratory frequency 2 hours after surgery(2 hours after surgery)
  • Oxygenation index 2 hours after surgery(2 hours after end of surgery)
  • FEV1 and FVC 2 hours after surgery(2 hours after end of surgery)
  • Pulmonary shunt 2 hours after surgery(2 hours after end of surgery)
  • Ventilation-perfusion ratio 2 hours after surgery(2 hours after end of surgery)
  • Oxygen supplement at discharge from the postanesthesia care unit(At discharge from the postanesthesia care unit, which will be approximately 2 hours after surgery)
  • Connection between pulmonary shunt and need for oxygen supplement(2 hours postoperatively and at discharge from the postanesthesia care unit)
  • FEV1 and FVC 24 hours after surgery(24 hours after surgery)
  • Pulmonary shunt 24 hours after surgery(24 hours after surgery)
  • Ventilation-perfusion ratio 24 hours after surgery(24 hours after surgery)
  • Arterial oxygen saturation 24 hours after surgery(24 hours after surgery)
  • Respiratory frequency 24 hours after surgery(24 hours after surgery)
  • Length of stay(Participants will be followed for the duration of hospital stay, an expected average of 3 days)
  • Respiratory failure after surgery(Participants will be followed for the duration of hospital stay, an expected average of 3 days)
  • Atelectasis(Participants will be followed for the duration of hospital stay, an expected average of 3 days)
  • High temperature(Participants will be followed for the duration of hospital stay, an expected average of 3 days)

研究者

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

Anne Kathrine Staehr

Research Assistant

Herlev Hospital

研究点 (2)

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