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Trial - NCT04904497


Column Value
Trial registration number NCT04904497
Full text link
Last imported at : May 29, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04904497

First author
Last imported at : May 29, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Eduardo Tobar, MD

Contact
Last imported at : May 29, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

etobar@hcuch.cl

Registration date
Last imported at : May 29, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

2021-05-27

Recruitment status
Last imported at : May 6, 2023, 8 p.m.
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : May 29, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : May 29, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : May 29, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : May 29, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : May 29, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : May 29, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

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
Last imported at : May 29, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

- 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

Number of arms
Last imported at : May 29, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : May 29, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

University of Chile

Inclusion age min
Last imported at : May 29, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : May 29, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : May 29, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Chile

Type of patients
Last imported at : May 29, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Critical disease at enrollment

Severity scale
Last imported at : May 29, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

8: Critical disease at enrollment

Total sample size
Last imported at : May 29, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

60

primary outcome
Last imported at : May 29, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Functional independence at hospital discharge

Notes
Last imported at : May 29, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : May 29, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 432, "treatment_name": "Early occupational therapy", "treatment_type": "Life support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]