Status:
RECRUITING
Careful Ventilation in Acute Respiratory Distress Syndrome (COVID-19 and Non-COVID-19)
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
University of Toronto
Conditions:
ARDS
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a multicenter randomized controlled clinical trial with an adaptive design assessing the efficacy of setting the ventilator based on measurements of respiratory mechanics (recruitability and e...
Detailed Description
Acute respiratory distress syndrome (ARDS) is a major public health problem affecting approximately 10% of patients in the intensive care unit (ICU) and 23% of all patients on a breathing machine (mec...
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 y
- Moderate or severe ARDS (PaO2/FiO2 ≤ 200 mmHg) within 48 h of meeting Berlin ARDS criteria (Patients who were eligible at the time of screening and whose PaO2/FiO2 became > 200 mm Hg under prone positioning when starting the protocol remained eligible)
Exclusion Criteria:
- Received continuous mechanical ventilation > 7 days
- Known or clinically suspected elevated intracranial pressure (>18mmHg) necessitating strict control of PaCO2
- Known pregnancy
- Broncho-pleural fistula
- Severe liver disease (Child-Pugh Score ≥ 10)
- BMI >40kg/m2
- Anticipating withdrawal of life support and/or shift to palliation as the goal of care
- Patient is receiving ECMO at time of randomization
Key Trial Info
Start Date :
November 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
740 Patients enrolled
Trial Details
Trial ID
NCT03963622
Start Date
November 23 2020
End Date
September 1 2026
Last Update
January 16 2026
Active Locations (33)
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1
New York University Grossman School of Medicine
New York, New York, United States, 10016
2
Centro de Educación Médica e Investigaciones Clínicas Dr Norberto Quirno (CEMIC)
Buenos Aires, Argentina
3
Complejo Médico Policía Federal Argentina Churruca Visca
Buenos Aires, Argentina
4
Hospital Británico de Buenos Aires
Buenos Aires, Argentina