A Prospective Randomized Trial to compare NIV to HFNC in COVID-19 patients not responding to Conventional Oxygen Therapy.

Not Applicable

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: U071- COVID 19 virus identified

• Registration Number: CTRI/2022/06/043525
• Lead Sponsor: Indian Council of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 August 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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) < 90 mm Hg or mean arterial pressure (MAP) < 65 mmHg. Use of vasopressors will be allowed up to noradrenaline requirement of 0.1mcg//kg/min or dopamine requirement of 10mcg/kg/min.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified