se of a new breathing device for covid 19 patients
Not Applicable
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/11/029146
- Lead Sponsor
- JFD Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patient may be diagnosed with COVID-19 pneumonia based on clinical history consistent with COVID 19 without PCR proof
2.Acute lung injury as evidenced by P/F ratio <300
3. Clinician deems failure of therapy with conventional low flow oxygen
Exclusion Criteria
1.Need for direct admission to the intensive care unit for invasive ventilation
2.Unconscious or patient with drowsiness.
3. Pneumothorax.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The co-primary efficacy outcome for this trial is a <br/ ><br>composite of invasive ventilation or death at 30 days after randomization. <br/ ><br>The co-primary safety outcome for this trial is any incident cases of hypopnea that results from a failure of the device at 30 days after randomizationTimepoint: 30 days after randomization
- Secondary Outcome Measures
Name Time Method 1. Oxygen consumed during stay in ICU on NIV. <br/ ><br>2. all cause mortality in 30 days, <br/ ><br>3) Patient comfort Visual scale (1-10) <br/ ><br>4) Frequency of carbon dioxide rebreathing assessed during treatment with a Capnograph during 30 days or up to discharge. <br/ ><br>At 180 days all subjects successfully discharged will be contacted on phone for collecting vital status at that timeTimepoint: 30 days and 180 days