Early Occupational Therapy in Mechanical Ventilated Patients With Covid-19

May 26, 2021 updated by: Eduardo Tobar, University of Chile

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Chile
    • Metropolitana
      • Santiago, Metropolitana, Chile
        • Recruiting
        • University of Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Day 28 (+/- 3 days) from beginning of mechanical ventilation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Coma-free days
Time Frame: 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
Defined as the number of days in the first 14 days with the SAS.
Delirium-coma free days
Time Frame: 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
Defined as the number of days in the first 14 days with the SAS and CAM-ICU
Cognitive status of patients
Time Frame: 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
Day 28 (+/- 3 days) from beginning of mechanical ventilation and day 90 (+/- 7 days)after hospital discharge
Motor status of patients
Time Frame: 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
Day 28 (+/- 3 days) from beginning of mechanical ventilation
Quality of life of patients
Time Frame: 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
Day 90 (+/- 7 days) from beginning of mechanical ventilation
Delirium-free days
Time Frame: 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
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
Time Frame: 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
Day 90 (+/- 7 days) from beginning of mechanical ventilation
Characterization of occupational therapy interventions
Time Frame: Days of patient hospitalization
Number of sessions implemented, number of sessions suspended
Days of patient hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Chile

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Base Valdivia
Hospital Santiago Oriente - Dr. Luis Tisné Brousse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Reh-Covid-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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