Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. >18 years of age 2. Diagnosed as COVID-19 positive by RT- PCR 3. Oxygen saturation 4. Can communicate and self-prone
Exclusion criteria
Exclusion criteria: 1. Any patient requiring immediate intubation and ventilatory care 2. Hemodynamic instability BP 3. Elevated intracranial pressure 4. Altered sensorium or history of seizures 5. Any psychiatric comorbidity 6. Massive hemoptysis in the last 48 hours ( >500 ml or requiring transfusion) 7. Morbid obesity where self-proning is not feasible 8. Pregnancy 9. Patients at high risk of requiring CPR or defibrillation (Known arrhythmias)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes (Phase 1 study): 1. Oxygen saturation measured using by pulse oximeter at 0, 10, 20, 30, 40 minutes Primary Outcomes (Phase 2 study): 1. Need for endotracheal intubation and mechanical ventilation measured at discharge or death 2. Mortality up to 30 days after enrolmentTimepoint: Primary outcomes (Phase 1 study): 1. Oxygen saturation measured using by pulse oximeter at 0, 10, 20, 30, 40 minutes Primary Outcomes (Phase 2 study): 1. Need for endotracheal intubation and mechanical ventilation measured at discharge or death 2. Mortality up to 30 days after enrolment | — |
Secondary
| Measure | Time frame |
|---|---|
| For phase 2 study: Phase 2 study: 1. Time to endotracheal intubation/ventilation measured using hospital record at discharge. 2. Duration of requirement of oxygen support measured using clinical proforma at patient discharge 3. Duration of hospital stay measured using using hospital record at dischargeTimepoint: Secondary outcome will be measured at patients at patients discharge or death. | — |
Countries
India
Contacts
All India Institute of Medical Sciences- Jodhpur