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

Description

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.

Study Start Date

September 2012

Estimated Completion Date

September 2017

Interventions

  • Other: Esophageal-pressure guided mechanical ventilation
  • Other: High PEEP mechanical ventilation

Specialties

  • Pulmonology: Critical Care
  • Emergency Medicine: Airway/Respiratory

MeSH Terms

  • Acute Lung Injury
  • High PEEP mechanical ventilation
  • Newborn
  • Respiratory Distress Syndrome

Study ID

Beth Israel Deaconess Medical Center -- 2011P-000242

Status

Unknown

Trial ID

NCT01681225

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

200

Sponsor

Beth Israel Deaconess Medical Center

Inclusion Criteria

  • Acute onset of ARDS as defined by the Berlin Consensus Conference definitions: 1. Hypoxemic respiratory failure with PaO2 / FIO2 ratio < 200 mmHg 2. b) Bilateral alveolar/interstitial infiltrates on chest x-ray, with opacities not present for more than 7 days 3. Respiratory failure not fully explained by cardiac failure or fluid overload 4. 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.

Exclusion Criteria

  • 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 > 3)
  • History of lung or liver 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

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (16)

Study Location Distance Name Phone Email
Montefiore Medical Center - Bronx, New York 40.3 miles None None None
Montefiore Medical Center - Bronx, New York 40.3 miles None None None
University of Massachusets Medical Center - Worcester, Massachusetts 106.5 miles None None None
University of Massachusets Medical Center - Worcester, Massachusetts 106.5 miles None None None
Beth Israel Deaconess Medical Center - Boston, Massachusetts 135.7 miles Todd Sarge MD 617-667-3112 tsarge@bidmc.harvard.edu
Beth Israel Deaconess Medical Center - Boston, Massachusetts 135.7 miles None None None
Brigham and Womens Hospital - Boston, Massachusetts 135.8 miles None None None
Brigham and Women's Hospital - Boston, Massachusetts 135.8 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 137.9 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 137.9 miles None None None
ShockTrauma University of Maryland Medical Center - Baltimore, Maryland 222.5 miles Lewis Rubinson MD None lrubinson@umm.edu
University of Michigan - Ann Arbor, Michigan 545.4 miles Pauline Park MD None parkpk@umich.edu
University of Cincinnati - Cincinnati, Ohio 612.9 miles None None None
Orlando Health - Orlando, Florida 992.3 miles None None None
University of California at San Diego - La Jolla, California 2,471.8 miles Jeremy R Beitler MD MPH None jbeitler@ucsd.edu
Stanford University Medical Center - Stanford, California 2,599.9 miles Joseph Levitt MD None jlevitt@stanford.edu

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