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Trial - IRCT20200612047740N4


Column Value
Trial registration number IRCT20200612047740N4
Full text link
Last imported at : June 18, 2022, 7:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : June 18, 2022, 7:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Dr Mojtaba Yousefi

Contact
Last imported at : June 18, 2022, 7:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

research@ajaums.ac.ir

Registration date
Last imported at : June 18, 2022, 7:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2022-06-18

Recruitment status
Last imported at : June 21, 2023, noon
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : June 18, 2022, 7:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : June 18, 2022, 7:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : June 18, 2022, 7:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : June 18, 2022, 7:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : June 18, 2022, 7:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : June 18, 2022, 7:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : June 18, 2022, 7:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Patients with Covid 19 with positive PCR or CT scan Hospitalized in the intensive care unit Patient is receiving non-mechanical ventilation Patient should be fed through the gastric feeding tube (NG tube) Informed consent of the patient or his legal guardian

Exclusion criteria
Last imported at : June 18, 2022, 7:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Coagulation disorders Gastrointestinal bleeding History of fractures and trauma to the base of the skull

Number of arms
Last imported at : June 18, 2022, 7:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : June 18, 2022, 7:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Artesh University of Medical Sciences

Inclusion age min
Last imported at : June 18, 2022, 7:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

0

Inclusion age max
Last imported at : June 18, 2022, 7:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : June 18, 2022, 7:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : June 18, 2022, 7:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Severe disease at enrollment

Severity scale
Last imported at : June 18, 2022, 7:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

6: Severe disease at enrollment

Total sample size
Last imported at : June 18, 2022, 7:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

90

primary outcome
Last imported at : June 18, 2022, 7:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Intra esophageal pressure Number of people with barotrauma

Notes
Last imported at : June 18, 2022, 7:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : June 18, 2022, 7:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 3

Arms
Last imported at : June 18, 2022, 7:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "managed with intraesophageal pressure", "treatment_id": 904, "treatment_name": "Non invasive ventilation", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "managed as usual", "treatment_id": 904, "treatment_name": "Non invasive ventilation", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}]