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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
Usual home care consists in supporting drug and oxygen therapy, mechanical ventilation, GP's assistance,and periodical in-hospital visit.
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.
Fondazione Salvatore Maugeri
Lumezzane, Brescia, Italy
Critical Patients Autonomy Planning (CPAP)
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.
Time frame: Changes from baseline and 4 weeks, and 6 months after home activity
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
Respiratory Functionality
Time frame: Changes from baseline and 4 weeks (average time), and 6 months after home activity
MRF 26
Quality of life evaluation.
Time frame: Changes between discharge at 4 weeks (average time) and 6 months after home activity
Likert Scale
Satisfaction for patient/caregiver
Time frame: Changes between discharge at 4 weeks (average time) and 6 months after home activity
Mortality
Clinical measure
Time frame: Changes between 3, 6 and 12 months post-discharge
MRC Scale and/or dynamometer
Rehabilitative measure referring to muscles force
Time frame: Changes between baseline, discharge at 4 weeks, and 6 months after home activity
6-min walking test
Rehabilitative measure evaluating the effort tolerance.
Time frame: Changes from baseline and discharge at 4 weeks, and 6 months after home activity
EuroQol
Quality of life evaluation
Time frame: Changes between discharge at 4 weeks (average time) and 6 months after home activity
Gussago Nursing Scale
Measure of dependency.
Time frame: Changes from baseline and 4 weeks, and 6 months after home activity
Barthel Index
Measure of dependency.
Time frame: Changes from baseline and 4 weeks, and 6 months after home activity
Pre-morbidity life-style (PLS)
Measure of dependency.
Time frame: Changes from baseline and 4 weeks, and 6 months after home activity
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