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Trial - CTRI/2021/04/032501


Column Value
Trial registration number CTRI/2021/04/032501
Full text link
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Gunasri K

Contact
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

dranand@outlook.com

Registration date
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2021-04-01

Recruitment status
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not recruiting

Study design
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Center
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

All COVID -19 positive patients ( by RT-PCR) with paO2/Fio2 (P/F) รข?? 150 to 250, with good sensorium, stable hemodynamics and pH > 7.2 <br/ >Absence of nasal pathology <br/ >

Exclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Hemodynamically unstable patients <br/ >Patients in shock/ severe acidosis <br/ >Epistaxis, basal skull fracture <br/ >

Number of arms
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

SRM Medical College and Research Centre

Inclusion age min
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

75

Countries
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

India

Type of patients
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Severe/critical disease at enrollment

Severity scale
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

7: Severe/critical disease at enrollment

Total sample size
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

60

primary outcome
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

To compare the efficacy of High Flow Nasal Cannula and Non Invasive Ventilation -Continuous Positive Airway Pressure in reducing need for invasive mechanical ventilation in patients with ARDS in COVID-19.Timepoint: 24 hours

Notes
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

| Declared number of arm (2.0) differs from found arms (3.0)

Phase
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Arms
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "", "treatment_id": 575, "treatment_name": "High flow nasal cannula", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 564, "treatment_name": "Helmet continuous positive airway pressure (cpap)", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}]