ARDS study: Respiratory Mechanics
Official title Careful Ventilation in Acute Respiratory Distress Syndrome (COVID-19 and Non-COVID-19)
ClinicalTrials.gov ID: NCT03963622
What this study is testing
- What it's testing
- The study compares two ventilator protocols to see if setting the machine based on lung measurements can reduce death at 60 days.
- Who it's for
- Adults with acute respiratory distress syndrome (ARDS) who need mechanical ventilation, whether from COVID‑19 or other causes.
- What's involved
- Participants will be randomly assigned to one of two ventilator settings. They will have regular lung function checks and routine care during their hospital stay.
- Time commitment
- The trial lasts until the patient is discharged or 60 days after starting ventilation, with follow‑up visits as needed for outcome assessment.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
- Buenos Aires, Argentina
- San Martin, Argentina
- Toronto, Canada
- Santiago, Chile
- Amiens, France
- Angers, France
- Argenteuil, France
- Beauvais, France
- Bordeaux, France
- Brest, France
- Cholet, France
- Créteil, France
- Grenoble, France
- Lille, France
- Mulhouse, France
- Nice, France
- Paris, France
- Poitiers, France
- Vannes, France
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States; Buenos Aires, Argentina; San Martin, Argentina; Toronto, Canada; Santiago, Chile; Amiens, France and 20 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.