Early Occupational Therapy in Mechanical Ventilated Patients With Covid-19: Multicentre Pilot Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- University of Chile
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Functional independence at hospital discharge
- Last Updated
- 4 years ago
Overview
Brief Summary
This study evaluates the feasibility of an early occupational therapy (OT) protocol in critical adult patients requiring mechanical ventilation with Covid-19.
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 OT plus ASDM. The intervention group will receive 20 OT sessions, which considers a predefined protocol of actions according to the patient's condition
Investigators
Eduardo Tobar
Associated professor
University of Chile
Eligibility Criteria
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
Outcomes
Primary Outcomes
Functional independence at hospital discharge
Time Frame: 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 Outcomes
- Coma-free days(Defined as the number of days in the first 14 days with the SAS.)
- Cognitive status of patients(Day 28 (+/- 3 days) from beginning of mechanical ventilation and day 90 (+/- 7 days)after hospital discharge)
- Characterization of occupational therapy interventions(Days of patient hospitalization)
- Delirium-free days(Defined as the number of days in the first 14 days with the CAM-ICU instrument negative and non-coma day.)
- Functional independence at hospital discharge(Day 90 (+/- 7 days) from beginning of mechanical ventilation)
- Motor status of patients(Day 28 (+/- 3 days) from beginning of mechanical ventilation)
- Delirium-coma free days(Defined as the number of days in the first 14 days with the SAS and CAM-ICU)
- Quality of life of patients(Day 90 (+/- 7 days) from beginning of mechanical ventilation)