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| Name | Class |
|---|---|
| Hospital Base Valdivia | UNKNOWN |
| Hospital Santiago Oriente - Dr. Luis Tisné Brousse | UNKNOWN |
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This study evaluates the feasibility of an early occupational therapy (OT) protocol in critical adult patients requiring mechanical ventilation with Covid-19.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Occupational Therapy | Experimental | 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 |
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| Standard | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Occupational Therapy | Behavioral | Occupational therapists will implement the following activities:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 28 (+/- 3 days) from beginning of mechanical ventilation |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium-free days | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eduardo Tobar, MD | Contact | +56229786009 | etobar@hcuch.cl | |
| Evelyn Alvarez, Master | Contact | +56229786009 | evalvarez@uchile.cl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chile | Recruiting | Santiago | Santiago Metropolitan | Chile |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D016638 | Critical Illness |
| D060825 | Cognitive Dysfunction |
| D001259 | Ataxia |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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
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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.
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| Coma-free days |
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 | 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 |
| 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 | Day 90 (+/- 7 days) from beginning of mechanical ventilation |
| 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 | Day 28 (+/- 3 days) from beginning of mechanical ventilation and day 90 (+/- 7 days)after hospital discharge |
| 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 | Day 28 (+/- 3 days) from beginning of mechanical ventilation |
| 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 | Day 90 (+/- 7 days) from beginning of mechanical ventilation |
| Characterization of occupational therapy interventions | Number of sessions implemented, number of sessions suspended | Days of patient hospitalization |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |