Early Occupational Therapy in Mechanical Ventilated Patients With Covid-19

Study Overview
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Brief Summary
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This study evaluates the feasibility of an early occupational therapy (OT) protocol in critical adult patients requiring mechanical ventilation with Covid-19.

Detailed Description
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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 OT plus ASDM. The intervention group will receive 20 OT sessions, which considers a predefined protocol of actions according to the patient's condition

Official Title
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Early Occupational Therapy in Mechanical Ventilated Patients With Covid-19: Multicentre Pilot Randomized Clinical Trial

Conditions
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Covid19, Critical Illness, Impairment, Cognitive, Impairment, Coordination

Intervention / Treatment
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* Behavioral: Early Occupational Therapy


Participation Criteria
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Eligibility Criteria
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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. Positive covid-19 diagnosis 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Occupational Therapy<br>These sessions will be implemented by occupational therapists trained in ICU, who will conduct 20 sessions of 30 min, distributed depending on the level of sedation, i) SAS (Sedation-Agitation Scale) 1 patients have one session each 48 h, evaluating the change of sedation level each 24 h; ii) SAS 2 patients have one session each 24 h, iii) SAS 3-5 have two sessions every day. The sessions will begin once the patient needs mechanical ventilation for at least 12 h | Behavioral: Early Occupational Therapy<br>* Occupational therapists will implement the following activities: Polysensory stimulation: external stimulation for increasing the level of alertness. It will be implemented with 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: trained family members and health staff about the intervention process<br>|
| No Intervention: Standard<br>The ASDM protocol will be implemented to mechanically ventilated patients in the ICU, following the aspects recommended by experts and the current evidence. For this, the team of medical, nurses, and physiotherapist will be trained to understand and facilitate the ASDM actions that each one must implement. Occupational Therapy interventions for control group will be allowed for this group only before 1 week after the first day on light sedation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional 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 | Day 28 (+/- 3 days) from beginning of mechanical ventilation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium-free days | CAM-ICU (Confusion Assessment Method Intensive Care Unit) instrument will be applied once a day by evaluatorhigher score is better, which will be compared between control and experimental group | 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 | 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 | Defined as the number of days in the first 14 days with the SAS and CAM-ICU | 
| Functional 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 | Day 90 (+/- 7 days) from beginning of mechanical ventilation | 
| 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 | 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 | 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 | Day 90 (+/- 7 days) from beginning of mechanical ventilation | 
| Characterization of occupational therapy interventions | Number of sessions implemented, number of sessions suspended | Days of patient hospitalization |