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Trial - IRCT20180129038549N15


Column Value
Trial registration number IRCT20180129038549N15
Full text link
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Mansour Siavash

Contact
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

research@mui.ac.ir

Registration date
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2021-12-20

Recruitment status
Last imported at : April 21, 2022, 1:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Oxygen saturation less than 90% despite receiving nasal oxygen ≥ 3 L/min or respiratory rate more than 24 breaths per minute The diagnosis of Covid-19 is confirmed based on PCR or lung HRCT Alert patients

Exclusion criteria
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Unstable hemodynamics Obesity Hypoventilation Syndrome Respiratory failure due to pulmonary edema Patients who do not tolerate the use of high pressure oxygen Cases in which emergency intubation is required Pregnant women

Number of arms
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Esfahan University of Medical Sciences

Inclusion age min
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Severe disease at enrollment

Severity scale
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

6: Severe disease at enrollment

Total sample size
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

66

primary outcome
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Increased blood oxygen saturation

Notes
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 3

Arms
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 577, "treatment_name": "High flow nasal oxygen", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2094, "treatment_name": "Non-rebreather oxygen mask", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}]