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临床试验/NCT03253380
NCT03253380Unknown不适用

Targets Of Early Rehabilitation Program In Critically Ill Chronic Obstructed Airway Disease Patients

Hend mohammed sayed mohammed0 个研究点目标入组 60 人开始时间: 2017年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
主要终点
Measure thirty day mortality rate among COPD patients who was subjected to early rehabilitation program during mechanical ventilation in RICU and those using current standard care

研究概览

简要总结

this study aim to compare the effect of early rehabilitation program on mechanical ventilated COPD patient in Respiratory ICU to those using current standard care as regarding :

  • morbidity and thirty day mortality
  • diaphragm function and weaning outcomes.
  • disease exacerbation
  • Duration spent on ventilator.
  • Length of ICU stay

详细描述

Mechanical ventilation (MV) in intensive care units (ICUs) essential in the management of respiratory failure, can result in respiratory dysfunction and inspiratory muscle weakness. Like any other striated muscle, respiratory muscle mass is affected by contractile inactivity. In fact, the respiratory muscles appear more sensitive to the effects of disuse compared with other striated muscles .

In humans, relatively brief periods of diaphragm disuse (<3 days) due to controlled mechanical ventilation are associated with diaphragm muscle fiber atrophy , force-generating capacity of the diaphragm was reduced by ±32 % after 5-6 days of controlled mechanical ventilation in intensive care unit (ICU) patients.

the degree of weakness is correlated with the duration of ventilation. One case-control study demonstrated that MV results in increased proteolysis and atrophy in the diaphragm muscle, while other skeletal muscles are spared .Respiratory muscle weakness is associated with adverse clinical outcomes, including difficult weaning from mechanical ventilation, increased mortality, and increased risk of ICU/hospital readmission .

Inspiratory muscle training (IMT) has been used in patients with chronic lung disease for many years, resulting in not just increased inspiratory muscle strength but also increased inspiratory muscle endurance, reduced dyspnoea and increased exercise tolerance and quality of life.

Early rehabilitation of MV patients in the ICU has been claimed not only to be safe but to reduce ICU length of stay, decrease time spent on MV, and improve outcomes after discharge

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • All COPD patients admitted to ICU are aged more than 18 years are haemodynamically stable and requiring minimal ventilatory support (ie positive end expiratory pressure (PEEP) less than or equal100.

排除标准

  • medically unstable (eg, new cardiac arrhythmia , heamodynamic unstable)
  • experiencing significant pain that interferes with breathing capacities, fractured ribs
  • have major disorders which affect the central nervous system resulting in permanent weakness that is not responsive to exercise training
  • COPD patient with neuromuscular disease or overlap with OSA (obstructive sleep apnea).

研究组 & 干预措施

early rehabilitation program on mechanical ventilated COPD pat

Experimental

compare the effect of early rehabilitation program on mechanical ventilated COPD patient in RICU to those using current standard care as regarding (morbidity and thirty day mortality ,diaphragm function and weaning outcomes, disease exacerbation , Duration spent on machin , Length of ICU stay.

干预措施: Early Rehabilitation Program In Critically Ill Chronic Obstructed Airway Disease patients (Other)

结局指标

主要结局

Measure thirty day mortality rate among COPD patients who was subjected to early rehabilitation program during mechanical ventilation in RICU and those using current standard care

时间窗: 2 years

measure the percentage of patients who die within 30 days after mechanical ventilation

Measure disease exacerbation among COPD patients who was subjected to early rehabilitation program during mechanical ventilation in RICU and those using current standard care

时间窗: 2 years

measure number of exacerbations in COPD patients during six months after weaning from mechanical ventilation

Measure duration spent on ventilator among COPD patients who was subjected to early rehabilitation program during mechanical ventilation in RICU and those using current standard care

时间窗: 2 years

measure duration of mechanical ventilation

Measure duration of ICU stay among COPD patients who was subjected to early rehabilitation program during mechanical ventilation in RICU and those using current standard care

时间窗: 2 years

measure duration of ICU stay

次要结局

未报告次要终点

研究者

发起方
Hend mohammed sayed mohammed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hend mohammed sayed mohammed

Assistant Lecturer

Assiut University

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