COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04497454

Eduardo LV Costa, PhD

eduardoleitecosta@gmail.com

2020-08-04

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: patients under mechanical ventilation with ards (berlin definition) caused by sars-cov2 infection: - ards diagnosis in less than 24 hours - respiratory system compliance of 0.6 ml/cmh2o/kg of pbw

- age < 18 years - active bronchopleural fistula - history of chronic and disabling respirator disease, requiring home oxygen treatment - chronic pulmonary arterial hypertension (pulmonary artery systolic pressure > 40 mmhg) - huge intrathoracic tumoral mass - electrical impedance tomography monitoring contraindications (as thoracic wounds or burns, electronic implantable devices) - hemodynamic instability (systolic pressure < 80 mmhg or mean arterial pressure < 60 mmhg, despite vasopressor drugs; and/or heart rate < 55bpm) - this patient may be included after recovered from hemodynamic instability - not drained pneumothorax or subcutaneous emphysema or bronchopleural fistula - patients at risk of intracranial hypertension development or post cardiopulmonary resuscitation (first 72 hours) - pregnancy - impossibility of monitoring with eit - not committed to full support or life expectation < 24 hours - legal responsible or clinical team refusal to participate in the study.

2

University of Sao Paulo General Hospital

18

100

Brazil

Critical disease at enrollment

8: Critical disease at enrollment

128

Average daily Modified Lung injury score until day 28

None

Not reported

[{"arm_notes": "Low PEEP-FiO2 table ARDS Network ventilation protocol", "treatment_id": 775, "treatment_name": "Mechanical ventilation", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "A mechanical ventilation strategy with the main goal to maintain DP < 16 cmH2O", "treatment_id": 775, "treatment_name": "Mechanical ventilation", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}]