Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Airway Pressure Release Ventilation: Patients will be transitioned from their previous volume assist-controlled ventilation to APRV with the following initial settings: high airway pres
low airway pressure (Plow) will be set at 5 cm H2O (minimal pressure level was used to prevent atelectasis per standard practice)
duration of release (Tlow) will be set as 1.5 times of expiratory time constant and further adjusted to achieve 75% of peak expiratory flow rate. Thigh will be around 5s to achieve a release frequency
PEEP levels will be adjusted by the ARDSnet PEEP-FiO2 table, and then tidal volume and the respiratory rate will be regulated to achieve the above target pH. When PFR is 150, PEEP will be tittered on
Sponsors
Dr Souvik Maitra
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients (aged between 18 & 75y) of either sex with laboratory confirmed SARS- CoV-2 infection, fulfilling Berlin definition of ARDS requiring invasive mechanical ventilation will be included in this study.
Exclusion criteria
Exclusion criteria: 1. Refusal to participate 2. Moribund patients with life expectancy less than 48h 3. Pregnancy 4. Patients requiring more than 20mcg/min of noradrenalin support or equivalent dose of another inotropes/ vasopressor 5. Co-existing chronic obstructive pulmonary disease 6. Co- existing Neuro-muscular diseases 7. Recruitment in another randomized trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| whether APRV reduces intensive care unit (ICU) mortality over LTV in mechanically ventilated SARS- CoV-2 infected patients with ARDSTimepoint: 28- day post randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the ventilator free days (VFD) in both the groupsTimepoint: At day 28- post randomization;2. To compare hospital mortality in both the groupsTimepoint: Till hospital discharge;3. To compare length of hospital stay in both the groups.Timepoint: Till hospital discharge;4. To compare oxygenation status 5. To compare hemodynamic status 6. To compare respiratory mechanicsTimepoint: At day 1,3, 5 and 7 post- randomization;7. To compare vasopressor free days (VFD) 8. To compare sedation free days (SFD)Timepoint: 28- day post- randomization;9. To compare the incidence of barotrauma 10. To compare the proportion of patients extubated 11. To compare number of spontaneous breathing trial sessionsTimepoint: At 28- day post- randomization | — |
Countries
India
Contacts
Public ContactDr Souvik Maitra
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed