- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01577927
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Brescia
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Lumezzane, Brescia, Italia, 25065
- Fondazione Salvatore Maugeri
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Critical Patients Autonomy Planning (CPAP)
Periodo de tiempo: 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.
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Changes from baseline and 4 weeks, and 6 months after home activity
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
Periodo de tiempo: Changes from baseline and 4 weeks (average time), and 6 months after home activity
|
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
Periodo de tiempo: Changes between discharge at 4 weeks (average time) and 6 months after home activity
|
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Changes from baseline and discharge at 4 weeks, and 6 months after home activity
|
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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Barthel Index
Periodo de tiempo: Changes from baseline and 4 weeks, and 6 months after home activity
|
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)
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Piero Ceriana, MD, Fondazione Salvatore Maugeri
- Director de estudio: Michele Vitacca, MD, Fondazione Salvatore Maugeri
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UTIR
- Dlg. 5685 on 28 May 2010 (Otro número de subvención/financiamiento: Lombardy Region)
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