Early Occupational Therapy in Mechanical Ventilated Patients With Covid-19

NCT ID: NCT04904497

Last Updated: 2021-05-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2021-12-31

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Early 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

Group Type: EXPERIMENTAL

Early Occupational Therapy

Intervention Type: 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

Standard

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Base Valdivia

UNKNOWN

Sponsor Role: collaborator

Hospital Santiago Oriente - Dr. Luis Tisné Brousse

UNKNOWN

Sponsor Role: collaborator

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

Eduardo Tobar

Associated professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Chile

Santiago, Santiago Metropolitan, Chile

Site Status: RECRUITING

Countries

Chile

Central Contacts

Eduardo Tobar, MD

Role: CONTACT

etobar@hcuch.cl

+56229786009

Evelyn Alvarez, Master

Role: CONTACT

evalvarez@uchile.cl

+56229786009

Facility Contacts

Eduardo Tobar, MD

Role: primary

etobar@hcuch.cl

+56229786009

Other Identifiers

Reh-Covid-19

Identifier Type: -

Identifier Source: org_study_id