PROVE Trial - Positive pRessure therapy in COVid-19 infEction
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/04/033175
- Lead Sponsor
- George Institute for Global Health India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Age >= 18 years
2. Laboratory confirmed COVID-19 positive infection
3. Requiring more than 40% oxygen (FiO2 > 0.4) â?? (requiring 6L or more of oxygen by Hudson mask
or nasal cannula) to maintain SpO2 >93%
1. Obtunded
2. The attending clinician is not committed to patient receiving mechanical ventilatory support
3. In the opinion of the treating clinician the patient is in respiratory distress and is eminently
requiring escalation of treatment including intubation and mechanical ventilation
4. Currently receiving either CPAP, BiPAP, high flow nasal prongs or mechanical ventilation
5. Participants usually on home ventilation (either CPAP or BiPAP)
6. Previous participation in PROVE trial
7. Known or suspected pregnancy
8. Enrolment in the study is not in the best interest of the patient as deemed by the treating clinician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method