Trial registration number
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CTRI/2021/06/034434 |
Full text link
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56931
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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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NISHA JHA
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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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nishajha1811@gmail.com
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Registration date
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-06-29
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Recruitment status
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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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 : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Center
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Sept. 8, 2021, 1:30 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.Confirmed cases of COVID 19 disease (RT รข?? PCR positive) <br/ >2.Cases of Severe COVID 19 disease with high Oxygen requirement i.e. not maintaining saturation above 92% with 12 l Oxygen flow via NRB masks <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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1.patient not willing to be a part of the study <br/ >2.patients having severe cough <br/ >3.pregnant patients and children below 12 years of age <br/ >4.patients not maintaining saturation >90% with maximum FGF (15 l) with either Bains or NRBM at 15 minutes of starting of Oxygen therapy for whom mechanical ventilation could be arranged <br/ > <br/ >
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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 : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Mahatma Gandhi Institute of Medical Sciences
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Inclusion age min
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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12
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Inclusion age max
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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90
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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 : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Severe disease at enrollment
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Severity scale
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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6: Severe disease at enrollment
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Total sample size
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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72
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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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1.Improved Oxygenation in terms of spO2 levels; and pA O2 levels <br/ >2.Decreased Total Oxygen requirement <br/ >Timepoint: till the patient is oxygenated using any of the study devices
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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 : Sept. 8, 2021, 1:30 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": 1885, "treatment_name": "Bains circuit", "treatment_type": "Respiratory support", "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"}]
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