This study evaluates the efficacy of an early and intensive occupational therapy (OT) protocol in critical adult patients requiring mechanical ventilation. Evaluating the functional independence at hospital discharge.
A randomized clinical trial with an experimental-control will be implemented, considering the prospective multicenter group, with parallel groups, in a 1:1 ratio, in 3 Chilean hospitals. A control group will has a standard analgesia, sedation, delirium and mobilization (ASDM) measures or an intervention group will have early and intensive OT plus ASDM. The intervention group will receive 20 OT sessions, mainly twice a day, which considers a predefined protocol of actions according to the patient's condition
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
226
Occupational therapists will implement the following activities: * Polysensory stimulation: external stimulation for increasing the level of alertness. It will be implemented with SAS 1 one session each 48 h and SAS 2 one session each 24 h. * Cognitive stimulation: bundle of exercises for activating mental functions, i.e: alertness, visual perception, memory, calculus, problem solving, praxis, language. Patients with SAS 3, 4 and 5. In SAS \<2, 6\> environmental orientation will be considered * Basic activities of daily living (BADLs): promotion of independence that initially practice hygiene, personal grooming. Patients with SAS 3, 4 and 5 * Motor function Stimulation: exercises to keep the patient's upper extremities active and functional. Patients with SAS with 3,4 and 5. Patients with SAS 1 and 2 will use adaptations to prevent edema and bedsores on vulnerable body areas * Education: daily visits by trained family members and health staff about the intervention process
University of Chile
Santiago, Santiago Metropolitan, Chile
RECRUITINGFunctional independence at hospital discharge
The FIM (Functional independence measure) instrument will be applied by evaluator team. This scale shows that higher score is better, which will be compared between control and experimental group
Time frame: Day 28 (+/- 3 days) from beginning of mechanical ventilation
Delirium-free days
CAM-ICU (Confusion Assessment Method Intensive Care Unit) instrument will be applied once a day by evaluator
Time frame: Defined as the number of days in the first 14 days with the CAM-ICU instrument negative and non-coma day.
Coma-free days
SAS (Sedation-Agitation Scale) instrument will be applied once a day by evaluator. If SAS 1-2: coma day
Time frame: Defined as the number of days in the first 14 days with the SAS.
Delirium-coma free days
SAS and CAM-ICU instruments will be applied once a day by evaluator. Every day without coma or delirium its an delirium-coma free day
Time frame: Defined as the number of days in the first 14 days with the SAS and CAM-ICU
Hazard ratio for delirium in the interventional versus control group
A composite analysis who involves delirium-coma free days to day 14. Hazard Ratio \<1 interpreted as a lower daily hazard of delirium - implying a shorter mean duration of delirium among days at risk for delirium
Time frame: Collecting from the first 14 days with the CAM-ICU instrument and coma.
Cognitive status of patients
MoCA (Montreal Cognitive Assessment) instrument (cognitive status).This scale shows that higher score is better, which will be compared between control and experimental group
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Time frame: Day 28 (+/- 3 days) from beginning of mechanical ventilation and day 90 (+/- 7 days)after hospital discharge
Motor status of patients
Grip strength (motor status) with dynamometer will be applied by evaluator. This scale shows that higher score is better, which will be compared between control and experimental group
Time frame: Day 28 (+/- 3 days) from beginning of mechanical ventilation
Quality of life of patients
EQ-5D-5L (Euro Qol 5 dimensions 5 level) will be applied by evaluator. It will be considered a cut-off point in the Chilean population
Time frame: Day 90 (+/- 7 days) from beginning of mechanical ventilation
Mental health
Hospital Anxiety and Depression Scale (HADS) will be applied by evaluator. This scale shows that lower score is better, which will be compared between control and experimental group
Time frame: Day 90 (+/- 7 days) from beginning of mechanical ventilation
Functional independence
The FIM (Functional independence measure) instrument will be applied by evaluator. This scale shows that higher score is better, which will be compared between control and experimental group
Time frame: Day 90 (+/- 7 days) from beginning of mechanical ventilation