Early and Intensive Occupational Therapy in Mechanical Ventilated Patients

Not Applicable

• Conditions: Critical Illness; Impairment, Cognitive; Impairment, Coordination; Ventilator Lung
• Interventions: Behavioral: Early and Intensive Occupational Therapy

• Registration Number: NCT04819529
• Lead Sponsor: University of Chile

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

Study Timeline

• Study Start: 2021-01-20
• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-29
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-07
• Primary Completion: 2022-07-20
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 226

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group - Early and intensive Occupational Therapy	Early and Intensive Occupational Therapy	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

University of Chile; 🇨🇱 Santiago, Metropolitana, Chile