Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Novel Non-Invasive Ventilation
Device [InVictoâ?¢]: We will connect the patients in the intervention group to InVictoâ?¢ device. The pressure, flow and FiO2 will be set by the intensivi
Sponsors
JFD Limited
Prof Michael Polkey
Eligibility
Inclusion criteria
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 3. Clinician deems failure of therapy with conventional low flow oxygen
Exclusion criteria
Exclusion criteria: 1.Need for direct admission to the intensive care unit for invasive ventilation 2.Unconscious or patient with drowsiness. 3. Pneumothorax.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The co-primary efficacy outcome for this trial is a composite of invasive ventilation or death at 30 days after randomization. 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
| Measure | Time frame |
|---|---|
| 1. Oxygen consumed during stay in ICU on NIV. 2. all cause mortality in 30 days, 3) Patient comfort Visual scale (1-10) 4) Frequency of carbon dioxide rebreathing assessed during treatment with a Capnograph during 30 days or up to discharge. At 180 days all subjects successfully discharged will be contacted on phone for collecting vital status at that timeTimepoint: 30 days and 180 days | — |
Countries
India
Contacts
Public ContactDr Alben Sigamani
Mazumdar Shaw Medical Center
Outcome results
None listed