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Feasibility Study of a Home Rehabilitative Network to Treat Prolonged Weaned Patients (UTIR)

2014年6月4日 更新者:Michele Vitacca、Fondazione Salvatore Maugeri

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

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.

研究类型

介入性

注册 (实际的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Brescia
      • Lumezzane、Brescia、意大利、25065
        • Fondazione Salvatore Maugeri

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
有源比较器:Usual home care
No assistance or care by PT.
Usual home care consists in supporting drug and oxygen therapy, mechanical ventilation, GP's assistance,and periodical in-hospital visit.
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.

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
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.
Changes from baseline and 4 weeks, and 6 months after home activity

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
Respiratory Functionality
Changes from baseline and 4 weeks (average time), and 6 months after home activity
MRF 26
大体时间:Changes between discharge at 4 weeks (average time) and 6 months after home activity
Quality of life evaluation.
Changes between discharge at 4 weeks (average time) and 6 months after home activity
Likert Scale
大体时间:Changes between discharge at 4 weeks (average time) and 6 months after home activity
Satisfaction for patient/caregiver
Changes between discharge at 4 weeks (average time) and 6 months after home activity
Mortality
大体时间:Changes between 3, 6 and 12 months post-discharge
Clinical measure
Changes between 3, 6 and 12 months post-discharge
MRC Scale and/or dynamometer
大体时间:Changes between baseline, discharge at 4 weeks, and 6 months after home activity
Rehabilitative measure referring to muscles force
Changes between baseline, discharge at 4 weeks, and 6 months after home activity
6-min walking test
大体时间:Changes from baseline and discharge at 4 weeks, and 6 months after home activity
Rehabilitative measure evaluating the effort tolerance.
Changes from baseline and discharge at 4 weeks, and 6 months after home activity
EuroQol
大体时间:Changes between discharge at 4 weeks (average time) and 6 months after home activity
Quality of life evaluation
Changes between discharge at 4 weeks (average time) and 6 months after home activity
Gussago Nursing Scale
大体时间:Changes from baseline and 4 weeks, and 6 months after home activity
Measure of dependency.
Changes from baseline and 4 weeks, and 6 months after home activity
Barthel Index
大体时间:Changes from baseline and 4 weeks, and 6 months after home activity
Measure of dependency.
Changes from baseline and 4 weeks, and 6 months after home activity
Pre-morbidity life-style (PLS)
大体时间:Changes from baseline and 4 weeks, and 6 months after home activity
Measure of dependency.
Changes from baseline and 4 weeks, and 6 months after home activity

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年7月1日

初级完成 (实际的)

2013年1月1日

研究完成 (实际的)

2013年7月1日

研究注册日期

首次提交

2012年4月10日

首先提交符合 QC 标准的

2012年4月13日

首次发布 (估计)

2012年4月16日

研究记录更新

最后更新发布 (估计)

2014年6月5日

上次提交的符合 QC 标准的更新

2014年6月4日

最后验证

2014年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • UTIR
  • Dlg. 5685 on 28 May 2010 (其他赠款/资助编号:Lombardy Region)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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