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临床试验/NCT00628992
NCT00628992终止不适用

Effects of Early Rehabilitation in Chronic Obstructive Pulmonary Disease Patients Under Mechanical Ventilation for Acute Respiratory Failure in Intensive Care Unit.

University Hospital, Strasbourg, France8 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2008年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
5
试验地点
8
主要终点
Number day breathing without assistance during the 28-day study period

研究概览

简要总结

Twenty per cent of the intensive care patients mechanically ventilated suffer from chronic obstructive pulmonary disease (COPD). These patients stay longer in Intensive Care which is more costly and they are more prone to nosocomial infection.In addition, they are longer bedridden and they develop muscular weakness.Prolonged inactivity results in respiratory and skeletal muscle weakness which curtails simple daily activity.The principal purpose of this study is to compare two types of muscular rehabilitation (electrical stimulation of the thigh and/or cycloergometer training) to classic passive mobilization of the leg.The second purpose is to analyse the effects of each type of rehabilitation on muscular fiber (structural and functional analysis) by muscular biopsies.Two hundred forty COPD patients admitted in the intensive care unit for acute respiratory failure will be randomized in 4: 1 fashion to receive passive mobilization of the legs(group 1, n=60), electrical stimulation of the thigh (group 2, n=60), cycloergometer training (group 3, n=60) or electrical stimulation of the thigh and cycloergometer training(group 4, n=60).The rehabilitation program will last 4 weeks with 5 sessions per week.In each group of patients, muscular biopsies will be done under local anaesthesia at the beginning and end of the rehabilitation programme and when they are discharged from the service.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

  • Patient older than 18 years of age
  • Chronic obstructive pulmonary disease
  • Intubated with mechanical ventilation
  • Patients without sedation or catecholamine
  • 2 previous spontaneous breathing trial at 24 hour intervals with T-piece having been unsuccessful
  • Conscious and cooperative state
  • Ability for the patient to sit in a armchair

排除标准

  • Non chronic obstructive pulmonary disease
  • Lack of patient involvement
  • Minor Patients
  • Patients under guardianship
  • Unconscious and non cooperative state
  • Patients unable to ride in a wheelchair
  • Patients not affiliated with a Social Security System
  • Patients under justice safeguard
  • Patients under curator ship

结局指标

主要结局

Number day breathing without assistance during the 28-day study period

时间窗: during the 28-day study period

次要结局

  • Length of stay in intensive care unit and hospital(Measured within the ICU stay of the patient)
  • Mortality at day 28 and day 90(Measured within the ICU stay of the patient)
  • Clinical measurement of muscular strength in lower limbs(day 0-2 and day 28-30)(Measured within the ICU stay of the patient)

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (8)

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