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Trial - IRCT20170617034592N2


Column Value
Trial registration number IRCT20170617034592N2
Full text link
Last imported at : March 2, 2022, 9 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : March 2, 2022, 9 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Shahid Beheshti University of Medical Sciences Vice-Chancellor of Research Affair

Contact
Last imported at : March 2, 2022, 9 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

info@sbmu.ac.ir

Registration date
Last imported at : March 2, 2022, 9 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2022-03-02

Recruitment status
Last imported at : July 23, 2022, 1:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : March 2, 2022, 9 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : March 2, 2022, 9 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : March 2, 2022, 9 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : March 2, 2022, 9 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Open label

Center
Last imported at : March 2, 2022, 9 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : March 2, 2022, 9 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : March 2, 2022, 9 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Patients with consciousness 15 according to Glasgow coma scale Patients aged 18 to 70 years old Patients admitted to the corona intensive care unit for at least 3 days Patients undergoing oxygen therapy through non-invasive mechanical ventilation for at least 3 days

Exclusion criteria
Last imported at : March 2, 2022, 9 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Patients with a history of non-invasive mechanical ventilation prior to hospitalization Patients with visual and auditory problems Patients with movement disorders and paralysis Psychiatric patient and taking sedatives before hospitalization

Number of arms
Last imported at : March 2, 2022, 9 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : March 2, 2022, 9 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Shahid Beheshti University of Medical Sciences

Inclusion age min
Last imported at : March 2, 2022, 9 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : March 2, 2022, 9 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

70

Countries
Last imported at : March 2, 2022, 9 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : March 2, 2022, 9 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Critical disease at enrollment

Severity scale
Last imported at : March 2, 2022, 9 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

8: Critical disease at enrollment

Total sample size
Last imported at : March 2, 2022, 9 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

80

primary outcome
Last imported at : March 2, 2022, 9 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

sedation

Notes
Last imported at : March 2, 2022, 9 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : March 2, 2022, 9 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Not reported

Arms
Last imported at : March 2, 2022, 9 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 837, "treatment_name": "Muscle relaxation", "treatment_type": "Rehabilitation", "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"}]