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Trial - CTRI/2020/12/029803


Column Value
Trial registration number CTRI/2020/12/029803
Full text link
Last imported at : Jan. 15, 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)

Aloka Samantaray

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

aloksvims@gmail.com

Registration date
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2020-12-15

Recruitment status
Last imported at : Jan. 15, 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 : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : Jan. 15, 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 adult patients aged 18 years and above diagnosed as acute hypoxemic respiratory failure with covid positive status

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

facial abnormalities <br/ >non cardiogenic pulmonary oedema <br/ >patients who do not give consent

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 : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Sri venkateswara institute of medical sciences

Inclusion age min
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : Jan. 15, 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 : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Severe/critical disease at enrollment

Severity scale
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

7: Severe/critical disease at enrollment

Total sample size
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

122

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

patients with treatment failure (those who need NIV support)Timepoint: Any point of time during course of treatment in ICU stay.

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 : Jan. 15, 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": "60 L/min", "treatment_id": 577, "treatment_name": "High flow nasal oxygen", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "15 L/min", "treatment_id": 906, "treatment_name": "Non rebreathing oxygen face mask", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}]