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Completed

NCT Number: NCT00127491

Mechanical Ventilation, Directed by Esophageal Pressure Measurements, in Patients With Acute Lung Injury

The purpose of this study is to see whether esophageal pressure (PES) measurements will allow the investigators to choose the best method of mechanical ventilation in patients with acute lung injury (ALI).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

The current standard of practice for ventilating patients with acute respiratory distress syndrome (ARDS) is the ARDSnet protocol (N Engl J Med 2000; 342:1301-1308) which has been shown to improve survival by limiting tidal volumes and thus preventing over distention of the lungs. However, the lungs can also be damaged by under-inflation during mechanical ventilation, and current practice ignores the effects of chest wall compression of the lungs, which can cause under-inflation. The investigators have observed that a fraction of critically ill patients with apparent ARDS have lung function abnormalities caused by extrinsic compression which can be estimated by PES measurements. Changing ventilator settings to apply normal physiological pressure to the lung has been beneficial in many such patients. This protocol will formally test the clinical utility of PES measurements in patients with ARDS.

This is a randomized controlled trial of therapy directed by esophageal balloon measurements (PES) versus therapy directed by ARDSnet protocol, the current standard of care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with ALI/ARDS according to the International Consensus Conference criteria:

  • PaO2/FiO2 ratio < 300
  • Acute onset
  • Bilateral infiltrates on chest radiography
  • PAOP < 18 or, in patients without a pulmonary artery catheter, no other evidence of abnormal cardiac function

Exclusion criteria

  • Patients with esophageal varices
  • Patients with esophageal trauma
  • Patients with recent esophageal surgery
  • Patients with coagulopathy (platelets < 80k or International Normalized Ratio [INR]> 2 )
  • Post transplant patients
  • Patients with significant broncho-pleural fistula

Treatment and study plan

Placement of an esophageal balloon measurements

Procedure

In both groups an esophageal balloon will be placed and baseline measurements recorded. In the EP group the mechanical ventilation settings will be determined based on these measurements. In the control group measurements will be recorded but ventilation will be based in the existing standard of care wich is the ARDSnet low tidal volume ventilation study. measurements will be repeated at 24, 48 and 72 hours or as needed.

Low tidal volume ventilation

Other

Low tidal volume ventilation strategy (ARDSnet)

Transpulmonary pressure-directed ventilation (EPVent)

Other

Transpulmonary pressure-directed ventilation using measurements from the esophageal balloon.

Primary outcomes

  1. Oxygenation as measured by the PO2/FiO2 (P/F) ratio

    Time frame: 72 hours from enrollment

Secondary outcomes

  1. Ventilator free days

    Time frame: At 28 days

  2. Markers of inflammation

    Time frame: In first 72 hours

  3. Mortality

    Time frame: At 28, 90 and 180 days

  4. Length of stay

    Time frame: Hospital and ICU

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

A RCT of Mechanical Ventilation, Directed by Esophageal Pressure Measurements, in Patients With Acute Lung Injury

Important dates

Study start
2004
Primary completion
2007
Study completion
2010
First posted
Aug 8, 2005
Registry last updated
Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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