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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Brescia
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Lumezzane, Brescia, Itália, 25065
- Fondazione Salvatore Maugeri
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
- 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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 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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Experimental: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Critical Patients Autonomy Planning (CPAP)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Piero Ceriana, MD, Fondazione Salvatore Maugeri
- Diretor de estudo: Michele Vitacca, MD, Fondazione Salvatore Maugeri
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UTIR
- Dlg. 5685 on 28 May 2010 (Número de outro subsídio/financiamento: Lombardy Region)
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