Status:
UNKNOWN
Mechanical Ventilation Strategy for Coronavirus Disease 2019 (COVID-19)
Lead Sponsor:
University of Sao Paulo General Hospital
Collaborating Sponsors:
InCor Heart Institute
Conditions:
Respiratory Distress Syndrome
Mechanical Ventilation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective, randomized, single-center, open-label controlled trial, designed to compare the efficacy of two ventilation strategies (Low Tidal Volume and positive end-expiratory pressure (PE...
Detailed Description
Mechanical ventilatory strategy of the ARDS Network low PEEP-FiO2 table will be followed in the control arm. This strategy consists of at least 12 hours of controlled mechanical ventilation following ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
May 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT04497454
Start Date
May 8 2020
End Date
December 1 2022
Last Update
May 11 2022
Active Locations (1)
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1
USP Instituto do Coração
São Paulo, Brazil, 05.403-010