Open Lung Strategy, Gas Distribution and Right Heart Function in ARDS Patients
Stopped early · Not applicable
Conditions studied: ARDS, Human, Lung Injury, Acute, Respiratory Distress Syndrome, Mechanical Ventilation Complication, Alveolar Edema, Right Heart Failure, Right Ventricular Dysfunction
In brief
The goal of this interventional crossover study, in intubated and mechanically ventilated Acute Respiratory Distress Syndrome (ARDS) patients, is to compare two positive end-expiratory pressure (PEEP) titration techniques regarding: respiratory mechanics, gas exchange, changes in aeration, ventilation/perfusion matching its impact on cardiac function, especially the right heart (RH). The PEEP titration techniques are: PEEP selection based on low PEEP/high FiO2 table ("PEEPARDSnet") and lung recruitment maneuver (LRM) plus PEEPdec titration based on the best compliance of the respiratory system("PEEPLRM").
Key facts
- Study ID
- NCT03202641
- Run by
- Massachusetts General Hospital
- People needed
- 2
- Starts
- 2019-06-19
- Expected to finish
- 2020-05-12
- Last updated by the study team
- 2025-12-19
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ARDS diagnosis within 72h after intubation
- Severe to moderate ARDS (PaO2 / FiO2 < 200 mmHg) with PEEP>5 cmH2O
- Presence of an arterial line
- Between 18 and 85 years old
You may not qualify if…
- Persistent systolic blood pressure < 90 mmHg and/or >180 mmHg despite the use of vasopressor or vasodilators
- Increment in vasopressors over the past two hour just before enrollment of: more than 15 mcg/min for norepinephrine and dopamine, more than 10 mcg/min in epinephrine; and more than 50 mcg/ min for phenylephrine.
- Advanced lung disease confirmed by computed tomography findings
- Presence or history of pneumothorax
- Severe coagulopathy (INR ≥ 4)
- Severe thrombocytopenia (Platelets count ≤ 5,000/mm3)
- Usage of any devices with electric current generation such as pacemaker or internal cardiac defibrillator
- Recent esophageal trauma or surgery
- Known presence of esophageal varices
- Pregnancy
Where it is running
- Massachussets General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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