| Trial registration number
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CTRI/2020/12/029585 |
Full text link
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49854
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First author
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Kunal Singh
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Contact
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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drkunals@aiimspatna.org
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Registration date
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2020-12-04
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Recruitment status
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Treatment
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Inclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1 Adult (Age >18years) <br/ >2 Confirmed COVID 19 patients tested positive for SARS-CoV-2 via nasopharyngeal swab by RT-PCR test and admitted to intensive care unit. <br/ >3 Acute hypoxemic respiratory failure defined by respiratory rate â?¥25 breaths/min, and PaO2/FiO2 â?¤300 mm Hg while spontaneously breathing under standard oxygen therapy. <br/ >
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Exclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Patients will be excluded if PaCO2 above 50 mm Hg, underlying chronic lung disease, cardiogenic pulmonary edema, severe shock, impending cardiopulmonary arrest, Glasgow coma scale score lower than 8 & absence of airway protective gag reflex.
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Number of arms
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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All India Institute Of Medical Sciences Patna
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Inclusion age min
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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19
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Inclusion age max
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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India
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Type of patients
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Critical disease at enrollment
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Severity scale
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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8: Critical disease at enrollment
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Total sample size
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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primary outcome
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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To compare the rates of endotracheal intubation between the two strategies.Timepoint: 28 days
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Notes
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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| Declared number of arm (2.0)
differs from found arms (3.0)
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Phase
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Arms
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 1950, "treatment_name": "High flow nasal oxygen+non invasive ventilation", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 577, "treatment_name": "High flow nasal oxygen", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}]
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