Feasibility and Efficacy of a Home Rehabilitative Network for Prolonged Weaned Patients Discharged From a Weaning Unit
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Fondazione Salvatore Maugeri
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Critical Patients Autonomy Planning (CPAP)
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
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.
Outcomes
Primary Outcomes
Critical Patients Autonomy Planning (CPAP)
Time Frame: 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.
Secondary Outcomes
- Barthel Index(Changes from baseline and 4 weeks, and 6 months after home activity)
- Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)(Changes from baseline and 4 weeks (average time), and 6 months after home activity)
- Likert Scale(Changes between discharge at 4 weeks (average time) and 6 months after home activity)
- Mortality(Changes between 3, 6 and 12 months post-discharge)
- Gussago Nursing Scale(Changes from baseline and 4 weeks, and 6 months after home activity)
- Pre-morbidity life-style (PLS)(Changes from baseline and 4 weeks, and 6 months after home activity)
- MRF 26(Changes between discharge at 4 weeks (average time) and 6 months after home activity)
- MRC Scale and/or dynamometer(Changes between baseline, discharge at 4 weeks, and 6 months after home activity)
- 6-min walking test(Changes from baseline and discharge at 4 weeks, and 6 months after home activity)
- EuroQol(Changes between discharge at 4 weeks (average time) and 6 months after home activity)
Investigators
Michele Vitacca
Principal investigator
Fondazione Salvatore Maugeri