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临床试验/NCT01577927
NCT01577927已完成不适用

Feasibility and Efficacy of a Home Rehabilitative Network for Prolonged Weaned Patients Discharged From a Weaning Unit

Fondazione Salvatore Maugeri1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Critical Patients Autonomy Planning (CPAP)

研究概览

简要总结

Patients at high complexity with severe chronic diseases can require several admission in intensive care units (ICU) to overcome acute exacerbations by the use of assisted ventilation. In the last 10 years, new technologies and beds in ICU evidenced a new group of patients often needing weaning procedures due to a long-lasting period of mechanical ventilation. These patients are often under chronic conditions with recurrent symptoms, reduced effort tolerance and depression.

Weaning process is a frail step in the medical history of a patient who has survived an acute episode of respiratory failure and has spent a period of time under mechanical ventilation. Patients are followed for the duration of in-hospital stay, an expected average period of 4 weeks.

When discharged fron an Intensive Care Unit (ICU) or a weaning center, the patient is usually managed by GPs and by the hospital where he has been admitted to following re-exacerbations. The conventional approach is for sure inadequate for this type of patient whose clinical complexity, disability and frailty need for a continuity of care through a higher complex approach of management.

A structured program of Home Rehabilitation could be a possible solution to this problem. Thus, the hypothesis of the study is to evaluate feasibility and sustainability and efficacy of a home rehabilitative network for prolonged weaned patients discharged from a weaning unit.

详细描述

Patients referred to the Fondazione Salvatore Maugeri for prolonged weaning are enrolled and trained in an individualised program of home care in order to recover their own autonomies. Home care compares 2 arms: usual care vs physiotherapist (PT)-assisted care. Usual care consists in supporting drug and oxygen therapy, mechanical ventilation, GP's assistance, periodical in-hospital visit. The PT-assisted home care is supported by PT at least 2 times/month, autonomous 50 min physical activity/working day by the help of a DVD. The physical activity consists in cyclette, calisthenic exercises, and training of the respiratory muscles. Few brief educational lessons by PT preceded the training activity. Every two weeks, PT calls the patient by phone for an educational reinforcement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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
否

入选标准

  • •General Inclusion criteria:
  • •Signature of the informed
  • •Good expectation of life
  • •Specific Inclusion Criteria : Score of general dependences < 19 according to the Critical Patients Autonomy Planning (CPAP) Scale

排除标准

  • •Patient with neuromuscular, highly progressive neurological diseases (i.e. amyotrophic lateral sclerosis), patient requiring surgical interventions, sedation, and hemodialysis.
  • •Unstable patient conditions as daily variability of the blood arterial pressure >20%, arrhythmias, PaO2/FiO2 < 300, unsatisfactory respiratory pattern, haemoglobin < 7 g /dL, temperature > 38°C, presence of neurological or orthopaedic side effects, and recent embolisms from TVP. Refusal.

研究组 & 干预措施

Usual home care

Active Comparator

No assistance or care by PT.

干预措施: Usual home care (Other)

PT-assisted home rehabilitation

Experimental

Assisted home care is supported by a PT at least 2 times/month. Few brief educational lessons preceeded the training activity that the patient performs by himself at home.

干预措施: PT-assisted home rehabilitation (Behavioral)

结局指标

主要结局

Critical Patients Autonomy Planning (CPAP)

时间窗: Changes from baseline and 4 weeks, and 6 months after home activity

CPAP is a measure of dependency. CPAP was evaluated at three different time-points: at in-hospital admission (baseline), at discharge (patients are followed for the duration of their in-hospital stay, an expected average time of 4 weeks), and after 6 months of physical activity at home.

次要结局

  • MRF 26(Changes between discharge at 4 weeks (average time) and 6 months after home activity)
  • Mortality(Changes between 3, 6 and 12 months post-discharge)
  • Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)(Changes from baseline and 4 weeks (average time), and 6 months after home activity)
  • Likert Scale(Changes between discharge at 4 weeks (average time) and 6 months after home activity)
  • MRC Scale and/or dynamometer(Changes between baseline, discharge at 4 weeks, and 6 months after home activity)
  • 6-min walking test(Changes from baseline and discharge at 4 weeks, and 6 months after home activity)
  • Gussago Nursing Scale(Changes from baseline and 4 weeks, and 6 months after home activity)
  • Pre-morbidity life-style (PLS)(Changes from baseline and 4 weeks, and 6 months after home activity)
  • Barthel Index(Changes from baseline and 4 weeks, and 6 months after home activity)
  • EuroQol(Changes between discharge at 4 weeks (average time) and 6 months after home activity)

研究者

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

Michele Vitacca

Principal investigator

Fondazione Salvatore Maugeri

研究点 (1)

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