Comparison of a helmet interface for non invasive ventilation versus high flow nasal oxygen therapy in management of Corona virus patients.
Not Applicable
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/12/029711
- Lead Sponsor
- AIIMS Patna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients diagnosed with corona virus infection presenting with all of the following.
a.A ratio of partial pressure of oxygen (PaO2) to (FiO2) below 300.
b.PaCO2 less than 45 mmHg as well as
c.Respiratory rate greater than 25/ minute
Exclusion Criteria
1. cardiogenic pulmonary edema,
2. severe neutropenia,
3. hemodynamic instability,
4. Use of vasopressors,
5. Glasgow Coma Scale score of 12 points or less
6. loss of protective gag reflex
7. urgent need for intubation
8. presence of metabolic acidosis with arterial blood pH < 7.3
9. History of any underlying chronic lung disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare rate of intubations in patients getting high flow nasal oxygen (HFNO) versus helmet interface NIV for management of Covid patients.Timepoint: Intubation at any time during hospital stay up to a maximum of 28 days shall be assessed.
- Secondary Outcome Measures
Name Time Method To assess intubation-free daysTimepoint: From the time of randomization to a maximum of 28 days after randomization.;To compare PaO2/FiO2 ratio, PaCO2 and PH changes after 24 hrs, and 48 hrs of therapyTimepoint: 24 hours and 48 hours after initiation of either therapy.;To compare rates of mortality or discharge from hospital.Timepoint: At time of mortality or discharge from hospital, upto a maximum of 28 days after randomization.;To compare time to intubation ie hours from time of initiation of intervention until intubation.Timepoint: From time of initiation of intervention to time of intubation.