Early Occupational Therapy in Mechanical Ventilated Patients With Covid-19

NCT04904497 | Unknown DMC

• 1 other identifier: Reh-Covid-19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Covid19; Critical Illness; Impairment, Cognitive; Impairment, Coordination

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Delirium-free days

  Defined as the number of days in the first 14 days with the CAM-ICU instrument negative and non-coma day.

• Coma-free days

  Defined as the number of days in the first 14 days with the SAS.

• Delirium-coma free days

  Defined as the number of days in the first 14 days with the SAS and CAM-ICU

• Functional independence at hospital discharge

  Day 90 (+/- 7 days) from beginning of mechanical ventilation

• Cognitive status of patients

  Day 28 (+/- 3 days) from beginning of mechanical ventilation and day 90 (+/- 7 days)after hospital discharge

Study Arms (2)

Early Occupational Therapy

EXPERIMENTAL

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

Standard

NO INTERVENTION

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

Interventions

Early Occupational Therapy BEHAVIORAL

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

Early Occupational Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chile: lead
• Hospital Base Valdivia: collaborator
• Hospital Santiago Oriente - Dr. Luis Tisné Brousse: collaborator

Study Sites (1)

University of Chile

Santiago, Santiago Metropolitan, Chile

RECRUITING

MeSH Terms

Conditions

COVID-19; Critical Illness; Cognitive Dysfunction; Ataxia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Central Study Contacts

Eduardo Tobar, MD

CONTACT

+56229786009; etobar@hcuch.cl

Evelyn Alvarez, Master

CONTACT

+56229786009; evalvarez@uchile.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Model Details: 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

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 27, 2021
• Study Start: April 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2021
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)