Clinical trial NCT04904497: Early Occupational Therapy in Mechanical Ventilated Patients With Covid-19
Official title: Early Occupational Therapy in Mechanical Ventilated Patients With Covid-19: Multicentre Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Critical Illness
Impairment, Cognitive
Impairment, Coordination
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: Hospital Base Valdivia
name: Hospital Santiago Oriente - Dr. Luis Tisné Brousse
First posted: 2021-05-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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) Education
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Functional independence at hospital discharge
timeFrame: Day 28 (+/- 3 days) from beginning of mechanical ventilation
Secondary outcomes:
measure: Delirium-free days
timeFrame: Defined as the number of days in the first 14 days with the CAM-ICU instrument negative and non-coma day.
measure: Coma-free days
timeFrame: Defined as the number of days in the first 14 days with the SAS.
measure: Delirium-coma free days
timeFrame: Defined as the number of days in the first 14 days with the SAS and CAM-ICU
measure: Functional independence at hospital discharge
timeFrame: Day 90 (+/- 7 days) from beginning of mechanical ventilation
measure: Cognitive status of patients
timeFrame: Day 28 (+/- 3 days) from beginning of mechanical ventilation and day 90 (+/- 7 days)after hospital discharge
measure: Motor status of patients
timeFrame: Day 28 (+/- 3 days) from beginning of mechanical ventilation
measure: Quality of life of patients
timeFrame: Day 90 (+/- 7 days) from beginning of mechanical ventilation
measure: Characterization of occupational therapy interventions
timeFrame: Days of patient hospitalization
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: University of Chile
state: Metropolitana
Study officials:
References: