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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
  Purpose
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).

Condition Intervention
Acute Lung Injury
Acute Respiratory Distress Syndrome
Procedure: Placement of an esophageal balloon measurements
Other: Low tidal volume ventilation
Other: Transpulmonary pressure-directed ventilation (EPVent)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A RCT of Mechanical Ventilation, Directed by Esophageal Pressure Measurements, in Patients With Acute Lung Injury

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Oxygenation as measured by the PO2/FiO2 (P/F) ratio [ Time Frame: 72 hours from enrollment ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 63
Study Start Date: May 2004
Study Completion Date: May 2010
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: Transpulmonary pressure-directed ventilation (EPVent)
Transpulmonary pressure-directed ventilation using measurements from the esophageal balloon.
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.
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)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127491

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Daniel S Talmor, MD, MPH Beth Israel Deaconess Medical Center
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniel Talmor, Edward Lowenstein Professor of Anaesthesia, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00127491     History of Changes
Other Study ID Numbers: 2004P000011
R01HL052586 ( US NIH Grant/Contract Award Number )
Study First Received: August 4, 2005
Last Updated: February 24, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Beth Israel Deaconess Medical Center:
Acute Lung Injury
Acute Respiratory Distress Syndrome
Mechanical Ventilation
Esophageal Pressures
Randomized Controlled Trial

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Wounds and Injuries
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries

ClinicalTrials.gov processed this record on March 24, 2017