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Early and Intensive Occupational Therapy in Mechanical Ventilated Patients

Primary Purpose

Critical Illness, Ventilator Lung, Impairment, Cognitive

Status
Unknown status
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Early and Intensive Occupational Therapy
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

Sites / Locations

  • University of ChileRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group - Early and intensive Occupational Therapy

Control group - Standard Analgesia,Sedation, Delirium and Mobilization (ASDM) Protocol

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Delirium-free days
CAM-ICU (Confusion Assessment Method Intensive Care Unit) instrument will be applied once a day by evaluator
Coma-free days
SAS (Sedation-Agitation Scale) instrument will be applied once a day by evaluator. If SAS 1-2: coma day
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
Hazard ratio for delirium in the interventional versus control group
A composite analysis who involves delirium-coma free days to day 14. Hazard Ratio <1 interpreted as a lower daily hazard of delirium - implying a shorter mean duration of delirium among days at risk for delirium
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
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
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
Mental health
Hospital Anxiety and Depression Scale (HADS) will be applied by evaluator. This scale shows that lower score is better, which will be compared between control and experimental group
Functional independence
The FIM (Functional independence measure) instrument will be applied by evaluator. This scale shows that higher score is better, which will be compared between control and experimental group

Full Information

First Posted
March 3, 2021
Last Updated
May 4, 2021
Sponsor
University of Chile
Collaborators
Hospital Base Valdivia, Hospital Santiago Oriente - Dr. Luis Tisné Brousse
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1. Study Identification

Unique Protocol Identification Number
NCT04819529
Brief Title
Early and Intensive Occupational Therapy in Mechanical Ventilated Patients
Official Title
Early and Intensive Occupational Therapy Improves the Functional Status of Critical Patients Undergoing Mechanical Ventilation at Discharge: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
July 20, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
Collaborators
Hospital Base Valdivia, Hospital Santiago Oriente - Dr. Luis Tisné Brousse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates the efficacy of an early and intensive occupational therapy (OT) protocol in critical adult patients requiring mechanical ventilation. Evaluating the functional independence at hospital discharge.
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 and intensive OT plus ASDM. The intervention group will receive 20 OT sessions, mainly twice a day, which considers a predefined protocol of actions according to the patient's condition

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Ventilator Lung, Impairment, Cognitive, Impairment, Coordination

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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) Education
Masking
Care ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
226 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group - Early and intensive Occupational Therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Control group - Standard Analgesia,Sedation, Delirium and Mobilization (ASDM) Protocol
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Early and Intensive Occupational Therapy
Intervention Description
Occupational therapists will implement the following activities: Polysensory stimulation: external stimulation for increasing the level of alertness. It will be implemented with SAS 1 one session each 48 h and 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: daily visits by trained family members and health staff about the intervention process
Primary Outcome Measure Information:
Title
Functional independence at hospital discharge
Description
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
Time Frame
Day 28 (+/- 3 days) from beginning of mechanical ventilation
Secondary Outcome Measure Information:
Title
Delirium-free days
Description
CAM-ICU (Confusion Assessment Method Intensive Care Unit) instrument will be applied once a day by evaluator
Time Frame
Defined as the number of days in the first 14 days with the CAM-ICU instrument negative and non-coma day.
Title
Coma-free days
Description
SAS (Sedation-Agitation Scale) instrument will be applied once a day by evaluator. If SAS 1-2: coma day
Time Frame
Defined as the number of days in the first 14 days with the SAS.
Title
Delirium-coma free days
Description
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
Time Frame
Defined as the number of days in the first 14 days with the SAS and CAM-ICU
Title
Hazard ratio for delirium in the interventional versus control group
Description
A composite analysis who involves delirium-coma free days to day 14. Hazard Ratio <1 interpreted as a lower daily hazard of delirium - implying a shorter mean duration of delirium among days at risk for delirium
Time Frame
Collecting from the first 14 days with the CAM-ICU instrument and coma.
Title
Cognitive status of patients
Description
MoCA (Montreal Cognitive Assessment) instrument (cognitive status).This scale shows that higher score is better, which will be compared between control and experimental group
Time Frame
Day 28 (+/- 3 days) from beginning of mechanical ventilation and day 90 (+/- 7 days)after hospital discharge
Title
Motor status of patients
Description
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
Time Frame
Day 28 (+/- 3 days) from beginning of mechanical ventilation
Title
Quality of life of patients
Description
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
Time Frame
Day 90 (+/- 7 days) from beginning of mechanical ventilation
Title
Mental health
Description
Hospital Anxiety and Depression Scale (HADS) will be applied by evaluator. This scale shows that lower score is better, which will be compared between control and experimental group
Time Frame
Day 90 (+/- 7 days) from beginning of mechanical ventilation
Title
Functional independence
Description
The FIM (Functional independence measure) instrument will be applied by evaluator. This scale shows that higher score is better, which will be compared between control and experimental group
Time Frame
Day 90 (+/- 7 days) from beginning of mechanical ventilation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo Tobar, MD
Phone
+56229786009
Email
etobar@hcuch.cl
First Name & Middle Initial & Last Name or Official Title & Degree
Evelyn Alvarez, Master
Phone
+56229786009
Email
evalvarez@uchile.cl
Facility Information:
Facility Name
University of Chile
City
Santiago
State/Province
Metropolitana
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Tobar, MD
Phone
+56229786009
Email
etobar@hcuch.cl
First Name & Middle Initial & Last Name & Degree
Eduardo Tobar, MD
First Name & Middle Initial & Last Name & Degree
Evelyn Alvarez, Master
First Name & Middle Initial & Last Name & Degree
Verónica Rojas, Master
First Name & Middle Initial & Last Name & Degree
Maricel Garrido, Master
First Name & Middle Initial & Last Name & Degree
José Ignacio Farias, PC
First Name & Middle Initial & Last Name & Degree
Nicole Jara, OT
First Name & Middle Initial & Last Name & Degree
Francia Acosta, OT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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Results Reference
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Results Reference
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PubMed Identifier
19363570
Citation
van der Schaaf M, Beelen A, Dongelmans DA, Vroom MB, Nollet F. Functional status after intensive care: a challenge for rehabilitation professionals to improve outcome. J Rehabil Med. 2009 Apr;41(5):360-6. doi: 10.2340/16501977-0333.
Results Reference
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PubMed Identifier
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Results Reference
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Citation
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Early and Intensive Occupational Therapy in Mechanical Ventilated Patients

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