Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: U071- COVID 19 virus identified
Conditions
Interventions
Intervention1: NIV Arm: In the NIV group, noninvasive ventilation will be delivered to the patient through an appropriate size full face non-vented mask interface that is connected to a standard ICU v
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: i. Patients with AHRF who failed COT as defined above will be included in study. ii. Patients with age >=18 years.
Exclusion criteria
Exclusion criteria: 1. PaCO2 of more than 45 mm Hg 2. Exacerbation of asthma or chronic respiratory failure 3. Hemodynamic instability defined as systolic blood pressure (SBP) 4. Urgent need for endotracheal intubation 5. Cardiac arrest 6. A do-not-intubate order 7. A decision not to participate 8. Contraindications to non-invasive ventilation including but not limited to uncooperative patients, inability to protect airway (impaired swallowing and cough), trauma or burns involving the face, facial, esophageal, or gastric surgery and apnea (poor respiratory drive). 9. A Glasgow Coma Scale (GCS) score of 12 points or less (on a scale from 3 to 15, with lower scores indicating reduced levels of conscious- ness) 10. Severe neutropenia 11. A Richmond agitation-sedation score (RASS) of more than +1 or less than -1. 12. Pregnant women. 13. Patient with any concurrent chronic medical condition or uncontrolled organ system failure, that in the opinion of the investigator precludes the subjectâ??s participation in the study or interferes with the interpretation of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a. To determine whether NIV is superior to HFNC in avoiding the need for intubation and invasive ventilation in patients with moderate to severe COVID-19 failing conventional oxygen therapyTimepoint: Day 1 of intubation | — |
Secondary
| Measure | Time frame |
|---|---|
| a. To evaluate the causes for failure of HFNC or NIV b. To determine and calculate the relative value of HACOR score & ROX Index in predicting HFNC or NIV failure c. To compare the length of ICU stay, length of hospital Stay, NIRT free days, invasive ventilator free days, and 28 day mortality in patients on HFNC or NIV d. To assess the level of patient comfort for HFNC or NIV using a standard VAS scale Timepoint: a Day 1 of intubation b Day 1 of intubation c Day of discharge from ICU Day of discharge from Hospital Day of removal of NIRT noninvasive respiratory therapy Day of removal of an invasive ventilator and Day 28 d Day 1 to Day of removal of NIV or HFNC | — |
Countries
India
Contacts
Public ContactDr Shivakumar Iyer
Bharati Vidyapeeth (Deemed to be) University Medical College
Outcome results
None listed