Trial registration number
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IRCT20180129038549N15 |
Full text link
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/60714
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First author
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Mansour Siavash
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Contact
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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research@mui.ac.ir
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Registration date
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-12-20
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Recruitment status
Last imported at : April 21, 2022, 1:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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single-center
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Study aim
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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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
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Exclusion criteria
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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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
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Number of arms
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Esfahan University of Medical Sciences
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Inclusion age min
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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18
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Inclusion age max
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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100
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Countries
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Severe disease at enrollment
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Severity scale
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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6: Severe disease at enrollment
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Total sample size
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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66
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primary outcome
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Increased blood oxygen saturation
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Notes
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 3
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Arms
Last imported at : Dec. 21, 2021, 5 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"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"}]
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