COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43447

Dr Ajisha Aravindan

ajishaa@gmail.com

2020-05-08

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

All adult patients > 16 years of age of either sex fulfilling WHO case definition of COVID-19 positive with ARDS (Berlin Criteria) needing invasive mechanical ventilation

Relatives who refuse to give consent or have unproven/suspected COVID-19 infection <br/ >age <16 years of age <br/ >BMI <18 kg/m2 or >40kg/m2 <br/ >pregnant <br/ >increased intracranial pressure <br/ >severe neuromuscular disease <br/ >severe chronic respiratory disease <br/ >severe chronic liver disease <br/ >active malignancy

2

All India Institute of Medical Sciences

16

99

India

Critical disease at enrollment

8: Critical disease at enrollment

40

Difference in the area under the curve (adjusted to survival time) for Murrayâ??s lung injury score between the two groups in the first 4 days.Timepoint: The first 4 days during ICU stay and mechanical ventilation

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "Conventional lung protective ventilation strategy( ARDSnet protocol) \nDetails: Ventilator settings used would be as per the PEEP/FiO2 combinations used in ARDSnet protocol. ", "treatment_id": 989, "treatment_name": "Physician guided peep (ardsnet protocol)", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "Lowest driving pressure guided PEEP\u00a0\nDetails: Initial PEEP would be kept at 5 cmH2O and driving pressure would be noted. PEEP would be stepped up in increments of 1 and the corresponding \u0394P would be checked after 1 minute. The PEEP levels at which \u0394P is the least would be chosen. In case the driving pressure achieved is same for more than one consecutive value of PEEP, then the lowest level of PEEP would be chosen. After 12 hours, driving pressures would be checked again and the same protocol would be followed to find the lowest \u0394P. If it is noted at any point that \u0394P increases with increase in PEEP, then PEEP would be reduced in decrements of 1 until the lowest \u0394P is achieved. The rest of the ventilator settings would be as per ARDSnet protocol. ", "treatment_id": 420, "treatment_name": "Driving pressure guided positive end expiratory pressure (peep) strategy", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}]