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Trial - CTRI/2021/01/030729


Column Value
Trial registration number CTRI/2021/01/030729
Full text link
Last imported at : Jan. 30, 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)

Dr Gayatri Shrinivas Jere

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

drrajvisheth@gmail.com

Registration date
Last imported at : Jan. 30, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2021-01-25

Recruitment status
Last imported at : Jan. 30, 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)

Crossover

Masking
Last imported at : Jan. 30, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Blind label

Center
Last imported at : Jan. 30, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : Jan. 30, 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)

Patients tested positive on Rt-PCR and are admitted. <br/ >- In the age group of 20-60 years. <br/ >- On Nasal Cannula or room air.

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

Those who are unwilling to participate in the study. <br/ >- Pregnant women. <br/ >- Patients who are intubated, on BiPAP or Bag and Mask as lying face down is not comfortable <br/ >with the tubes attached for oxygenation. <br/ >- Recent Surgical intervention <br/ >-Cognitive impairment or Neurological conditions like Stroke, <br/ >-Haemodynamically unstable. <br/ >- Obese patients (BMI > 30 kg/m2) as lying face down is uncomfortable due to abdominal <br/ >bulk.

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. 30, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Inclusion age min
Last imported at : Jan. 30, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

20

Inclusion age max
Last imported at : Jan. 30, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

60

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. 30, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Moderate disease at enrollment

Severity scale
Last imported at : Jan. 30, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

3: Moderate disease at enrollment

Total sample size
Last imported at : Jan. 30, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

30

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

1. To find the effects of Crocodile breathing on physiological parameters <br/ >(PR; RR; SpO2; RPE) and Pulmonary Function test (Single Breath Count test and Chest <br/ >Expansion) in COVID-19 patients. <br/ >2. To find the effects of prone positioning on physiological parameters and Pulmonary Function tests in COVID-19 <br/ >patients. <br/ >3. To compare the effects of Crocodile breathing and prone positioning on physiological <br/ >parameters and Pulmonary Function test in COVID-19 patients.Timepoint: At baseline and immediately post the maneuver.

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. 30, 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": 357, "treatment_name": "Crocodile breathing", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1027, "treatment_name": "Prone position", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}]