Critical Illness, Impairment, Cognitive, Impairment, Coordination, Ventilator Lung
Conditions
Brief summary
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.
Detailed description
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
Interventions
BEHAVIORALEarly and Intensive Occupational Therapy
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
Sponsors
Hospital Base Valdivia
Hospital Santiago Oriente - Dr. Luis Tisné Brousse
University of Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
In this study, researchers, recruiters, evaluators, control group team and data analyst will be masked. These teams will not have contact with the interventionists of the experimental group. Evaluators who have contact with the patients of both groups, they will be professionals from other medical units, who do not know the ICU team, and will only be able to maintain their dialog, according to the guideline of each evaluation. It is not possible to mask the treating occupational therapist and patient receiving OT.
Intervention model description
A control group (standard ASDM measures) or an intervention group (early and intensive occupational therapy + ASDM) will be randomized. The intervention group will receive 20 occupational therapy sessions. The interventions will be organized on the basis of i) level of sedation, ii) presence or absence of delirium (according to CAM ICU +/- (Confusion Assessment Method Intensive Care Unit)), iii) movement with or without gravity (cut-off point 3 points in elbow flexion movement in Medical Research Council(MRC)). The areas of intervention implemented by occupational therapist will be: i) Polysensory stimulation, ii) Cognitive stimulation, iii) Basic activities of daily living, iv) Motor function stimulation, v) Education
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age equal to or greater than 18 years. * Need for hospitalization in ICU. * At least 12 h of invasive mechanical ventilation * Informed consent signed by legal representative and / or patient.
Exclusion criteria
* Known cognitive impairment before admission with short IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly) Scores\> 3.3 were excluded. * Previous functional impairment, FAQ (Functional Activities Questionnaire) defined as \> 6 points. * Severe communication disorder and cultural limitation of language (language different from Spanish) * Patient with limited therapeutic proportionality. * Neurocritical patients (moderate-severe Traumatic Brain Injury / stroke of some kind / among others) * Spinal injury or unstable fractures that limit mobilization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional independence at hospital discharge | Day 28 (+/- 3 days) from beginning of mechanical ventilation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coma-free days | Defined as the number of days in the first 14 days with the SAS. | SAS (Sedation-Agitation Scale) instrument will be applied once a day by evaluator. If SAS 1-2: coma day |
| Delirium-coma free days | Defined as the number of days in the first 14 days with the SAS and CAM-ICU | 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 |
| Hazard ratio for delirium in the interventional versus control group | Collecting from the first 14 days with the CAM-ICU instrument and coma. | 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 |
| Cognitive status of patients | Day 28 (+/- 3 days) from beginning of mechanical ventilation and day 90 (+/- 7 days)after hospital discharge | MoCA (Montreal Cognitive Assessment) instrument (cognitive status).This scale shows that higher score is better, which will be compared between control and experimental group |
| Delirium-free days | Defined as the number of days in the first 14 days with the CAM-ICU instrument negative and non-coma day. | CAM-ICU (Confusion Assessment Method Intensive Care Unit) instrument will be applied once a day by evaluator |
| Quality of life of patients | Day 90 (+/- 7 days) from beginning of mechanical ventilation | 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 |
| Mental health | Day 90 (+/- 7 days) from beginning of mechanical ventilation | 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 |
| Functional independence | Day 90 (+/- 7 days) from beginning of mechanical ventilation | 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 |
| Motor status of patients | Day 28 (+/- 3 days) from beginning of mechanical ventilation | 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 |
Countries
Chile
Contacts
Primary ContactEduardo Tobar, MD
Backup ContactEvelyn Alvarez, Master
Outcome results
None listed