Feasibility Study of a Home Rehabilitative Network to Treat Prolonged Weaned Patients (UTIR)
Feasibility and Efficacy of a Home Rehabilitative Network for Prolonged Weaned Patients Discharged From a Weaning Unit
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.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Brescia
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Lumezzane、Brescia、意大利、25065
- Fondazione Salvatore Maugeri
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
- General Inclusion criteria: 1. Signature of the informed 2. Good expectation of life
- Specific Inclusion Criteria : Score of general dependences < 19 according to the Critical Patients Autonomy Planning (CPAP) Scale
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Usual home care
No assistance or care by PT.
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Usual home care consists in supporting drug and oxygen therapy, mechanical ventilation, GP's assistance,and periodical in-hospital visit.
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实验性的:PT-assisted home rehabilitation
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.
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Patient performs 50 min physical activity/working day autonomously by the help of a DVD. The physical activity consists in cyclette, calisthenic exercises, and training of the respiratory muscles. Every two weeks, PT phones the patient for an educational reinforcement. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Critical Patients Autonomy Planning (CPAP)
大体时间:Changes from baseline and 4 weeks, and 6 months after home activity
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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.
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Changes from baseline and 4 weeks, and 6 months after home activity
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
大体时间:Changes from baseline and 4 weeks (average time), and 6 months after home activity
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Respiratory Functionality
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Changes from baseline and 4 weeks (average time), and 6 months after home activity
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MRF 26
大体时间:Changes between discharge at 4 weeks (average time) and 6 months after home activity
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Quality of life evaluation.
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Changes between discharge at 4 weeks (average time) and 6 months after home activity
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Likert Scale
大体时间:Changes between discharge at 4 weeks (average time) and 6 months after home activity
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Satisfaction for patient/caregiver
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Changes between discharge at 4 weeks (average time) and 6 months after home activity
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Mortality
大体时间:Changes between 3, 6 and 12 months post-discharge
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Clinical measure
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Changes between 3, 6 and 12 months post-discharge
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MRC Scale and/or dynamometer
大体时间:Changes between baseline, discharge at 4 weeks, and 6 months after home activity
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Rehabilitative measure referring to muscles force
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Changes between baseline, discharge at 4 weeks, and 6 months after home activity
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6-min walking test
大体时间:Changes from baseline and discharge at 4 weeks, and 6 months after home activity
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Rehabilitative measure evaluating the effort tolerance.
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Changes from baseline and discharge at 4 weeks, and 6 months after home activity
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EuroQol
大体时间:Changes between discharge at 4 weeks (average time) and 6 months after home activity
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Quality of life evaluation
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Changes between discharge at 4 weeks (average time) and 6 months after home activity
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Gussago Nursing Scale
大体时间:Changes from baseline and 4 weeks, and 6 months after home activity
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Measure of dependency.
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Changes from baseline and 4 weeks, and 6 months after home activity
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Barthel Index
大体时间:Changes from baseline and 4 weeks, and 6 months after home activity
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Measure of dependency.
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Changes from baseline and 4 weeks, and 6 months after home activity
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Pre-morbidity life-style (PLS)
大体时间:Changes from baseline and 4 weeks, and 6 months after home activity
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Measure of dependency.
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Changes from baseline and 4 weeks, and 6 months after home activity
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合作者和调查者
调查人员
- 首席研究员:Piero Ceriana, MD、Fondazione Salvatore Maugeri
- 研究主任:Michele Vitacca, MD、Fondazione Salvatore Maugeri
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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