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

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Daniel Talmor, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00127491
First received: August 4, 2005
Last updated: February 24, 2017
Last verified: February 2017
August 4, 2005
February 24, 2017
May 2004
August 2007   (Final data collection date for primary outcome measure)
Oxygenation as measured by the PO2/FiO2 (P/F) ratio [ Time Frame: 72 hours from enrollment ]
Oxygenation as measured by the PO2/FiO2 (P/F) ratio
Complete list of historical versions of study NCT00127491 on ClinicalTrials.gov Archive Site
  • Ventilator free days [ Time Frame: At 28 days ]
  • Markers of inflammation [ Time Frame: In first 72 hours ]
  • Mortality [ Time Frame: At 28, 90 and 180 days ]
  • Length of stay [ Time Frame: Hospital and ICU ]
  • Ventilator free days
  • Length of stay
  • Markers of inflammation
  • Mortality
Not Provided
Not Provided
 
Mechanical Ventilation, Directed by Esophageal Pressure Measurements, in Patients With Acute Lung Injury
A RCT of 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).

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome
  • Procedure: Placement of an esophageal balloon measurements
    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.
  • Other: Low tidal volume ventilation
    Low tidal volume ventilation strategy (ARDSnet)
  • Other: Transpulmonary pressure-directed ventilation (EPVent)
    Transpulmonary pressure-directed ventilation using measurements from the esophageal balloon.
  • Experimental: EPVent
    All patients will have an esophageal balloon placed for the purpose of obtaining transpulmonary pressure measurements. The intervention group will undergo transpulmonary pressure-directed controlled mechanical ventilation using parameters directed by the initial balloon measurements. Driving pressures will be adjusted to maintain a transpulmonary plateau pressure of less then 30. The PEEP setting will be set to achieve a transpulmonary end expiratory pressure of 0. Repeat PES measurements will be done at 24, 48 and 72 hours following the initial measurements. Additional measurements will be taken as clinically indicated. Ventilator management by PES measurements will continue for a period of 72 hours.
    Interventions:
    • Procedure: Placement of an esophageal balloon measurements
    • Other: Transpulmonary pressure-directed ventilation (EPVent)
  • Active Comparator: Control
    All patients will have an esophageal balloon placed for the purpose of obtaining transpulmonary pressure measurements. The control group will be managed using the low tidal volume strategy laid out by the NIHBLI ARDSnet study. These recommendations include a set tidal volume of 6 ml/ kg. Respiratory rate and PEEP are set to maintain adequate ventilation and oxygenation. These settings will be continued for a period of 72 hours.
    Interventions:
    • Procedure: Placement of an esophageal balloon measurements
    • Other: Low tidal volume ventilation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
May 2010
August 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00127491
2004P000011
R01HL052586 ( US NIH Grant/Contract Award Number )
Yes
Not Provided
No
Not Provided
Daniel Talmor, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Daniel S Talmor, MD, MPH Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP