Early Occupational Therapy in Mechanical Ventilated Patients With Covid-19

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04904497
• Other study ID #: Reh-Covid-19
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2021
• Source: University of Chile
• Contact: Eduardo Tobar, MD
• Phone: +56229786009
• Email: etobar[@]hcuch.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ataxia
• Cognitive Dysfunction
• Covid19
• Critical Illness
• Impairment, Cognitive
• Impairment, Coordination

Intervention

Behavioral:
• Early 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 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

Locations

Country	Name	City	State
Chile	University of Chile	Santiago	Metropolitana

Sponsors (3)

Lead Sponsor	Collaborator
University of Chile	Hospital Base Valdivia, Hospital Santiago Oriente - Dr. Luis Tisné Brousse

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Characterization of occupational therapy interventions	Number of sessions implemented, number of sessions suspended	Days of patient hospitalization