Trial registration number
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CTRI/2021/01/030729 |
Full text link
Last imported at : Jan. 30, 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=51654
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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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Dr Gayatri Shrinivas Jere
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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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drrajvisheth@gmail.com
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Registration date
Last imported at : Jan. 30, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-01-25
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Recruitment status
Last imported at : Jan. 30, 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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Crossover
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Masking
Last imported at : Jan. 30, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Blind label
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Center
Last imported at : Jan. 30, 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. 30, 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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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.
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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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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.
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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. 30, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Inclusion age min
Last imported at : Jan. 30, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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20
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Inclusion age max
Last imported at : Jan. 30, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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60
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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. 30, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Moderate disease at enrollment
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Severity scale
Last imported at : Jan. 30, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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3: Moderate disease at enrollment
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Total sample size
Last imported at : Jan. 30, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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30
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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. 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.
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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. 30, 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": 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"}]
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