Early Occupational Therapy in Mechanical Ventilated Patients With Covid-19

Sponsor

University of Chile (Other)

Overall Status

Recruiting

CT.gov ID

NCT04904497

Collaborator

Hospital Base Valdivia (Other), Hospital Santiago Oriente - Dr. Luis Tisné Brousse (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Covid19 Critical Illness Impairment, Cognitive Impairment, Coordination	Behavioral: Early Occupational Therapy	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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) EducationA 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

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	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
No Intervention: 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

Arm

Intervention/Treatment

Experimental: 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

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

No Intervention: 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

Outcome Measures

Primary Outcome Measures

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

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 evaluatorhigher score is better, which will be compared between control and experimental group
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
Functional independence at hospital discharge [Day 90 (+/- 7 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
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
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
Characterization of occupational therapy interventions [Days of patient hospitalization]
Number of sessions implemented, number of sessions suspended

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chile	Santiago	Metropolitana	Chile

Sponsors and Collaborators

University of Chile
Hospital Base Valdivia
Hospital Santiago Oriente - Dr. Luis Tisné Brousse

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eduardo Tobar, Associated professor, University of Chile

ClinicalTrials.gov Identifier:

NCT04904497

Other Study ID Numbers:

Reh-Covid-19

First Posted:

May 27, 2021

Last Update Posted:

May 27, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Ataxia

Critical Illness

Cognitive Dysfunction

Study Results

No Results Posted as of May 27, 2021