Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Oxygen delivery via Materialise Passive Non-Invasive PEEP device mask
: Oxygen will be delivered via the Materialise Passive Non-Invasive PEEP device mask continuously through out the d
Sponsors
George Institute for Global Health India
Eligibility
Inclusion criteria
Inclusion criteria: 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%
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Need for escalation of respiratory support, defined as, need for CPAP, BIPAP, or invasive mechanical ventilationTimepoint: Upto 14 days following randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Costs of hospitalisationTimepoint: Continuous for the length of stay in hospital;Daily blood pressures Timepoint: Upto 14 days following randomization;Daily lowest and highest oxygen flow rates Timepoint: Upto 14 days;Daily lowest and highest oxygen saturations Timepoint: Upto 14 days;Days alive and free of ICU Timepoint: Upto 14 days;Days off workTimepoint: Continuous;Duration of InterventionTimepoint: Continuous for the length of stay in hospital;Duration of mechanical ventilation Timepoint: Upto 14 days;Dyspnoea scaleTimepoint: Upto 14 days following randomization;Episodes of aspiration pneumonia Timepoint: Continuous for the length of stay in hospital;Evidence of barotrauma defined as: clinical or radiological evidence of pneumothorax or subcutaneous emphysema Timepoint: Continuous for the length of stay in hospital;Length of stay in ICU and hospitalTimepoint: Continuous;MortalityTimepoint: At Day 28;Mortality Timepoint: At Day 7;Need for vasopressor or inotropic support Timepoint: Upto 14 days;Oxygen saturation profiles Timepoint: Immediately after commencement of interventions;Process Outcome: Duration of InterventionTimepoint: Continuous for the length of stay in hospital;Process Outcome: Ease of use score as determined by the Health Care Professional Timepoint: Continuous for the length of stay in hospital;Process Outcome: Measurement of PEEP in the NIP mask in a cohort of 50 patients Timepoint: Continuous for the length of stay in hospital | — |
Countries
India
Contacts
Public ContactProfessor Vivekanand Jha
George Institute for Global Health
Outcome results
None listed