EPVent 2- A Phase II Study of Mechanical Ventilation Directed by Transpulmonary Pressures

Completed · Not applicable

Conditions studied: Acute Respiratory Distress Syndrome

In brief

This phase II multi-centered, randomized controlled trial of mechanical ventilation directed by esophageal pressure measurement will test the primary hypothesis that using a strategy of maintaining a minimal but positive transpulmonary pressure (Ptp = airway pressure minus pleural pressure) throughout the ventilatory cycle will lead to an improvement in patient survival.

Key facts

Study ID

NCT01681225

Run by

Beth Israel Deaconess Medical Center

People needed

202

Starts

2012-10-31

Expected to finish

2018-10-19

Last updated by the study team

2019-12-03

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Acute onset of ARDS as defined by the Berlin Consensus Conference definitions:
• Hypoxemic respiratory failure with PaO2 / FIO2 ratio < 200 mmHg
• b) Bilateral alveolar/interstitial infiltrates on chest x-ray, with opacities not present for more than 7 days
• Respiratory failure not fully explained by cardiac failure or fluid overload
• Intubation on controlled ventilation and receiving PEEP ≥ 5 cm H2O
• Age 16 years or older
• Duration of ARDS 36 hours or less from meeting final Berlin criterion.

You may not qualify if…

• Received mechanical ventilation more than 96 hours
• Recently treated or bleeding varices, esophageal stricture, hematemesis, esophageal trauma, recent esophageal surgery or other contraindication for nasogastric tube placement
• Severe coagulopathy (platelet count < 5000/microliter or INR > 4)
• History of lung transplantation
• Elevated intracranial pressure or conditions where hypercapnia-induced elevations in intracranial pressure should be avoided
• Evidence of active air leak from the lung
• not committed to full support
• Participation in other intervention trials for ARDS or for sepsis within the past 30 days.
• Neuromuscular disease that impairs ability to ventilate spontaneously
• Severe chronic liver disease, defined as Child-Pugh Score of ≥12
• Treating clinician refusal, or unwillingness to commit to controlled ventilation for at least 24 hours
• Inability to get informed consent from the patient or surrogate.
• Use of rescue therapies for prior to enrollment (e.g. nitric oxide, ECMO, prone positioning, high frequency oscillation). This does not exclude cases where these therapies were used as the initial mode of ventilation

Where it is running

• University of California at San Diego — La Jolla, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Orlando Health — Orlando, Florida, United States
• Shock-Trauma University of Maryland Medical Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Massachusets Medical Center — Worcester, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Vancouver General Hospital — Vancouver, British Columbia, Canada
• St Joseph's Healthcare — Hamilton, Ontario, Canada
• University Health Network — Toronto, Ontario, Canada
• Laval University — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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