Trial record 14 of 524 for:    "Acute respiratory distress syndrome"

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00127491
First received: August 4, 2005
Last updated: December 9, 2013
Last verified: December 2013
  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 Phase
Acute Lung Injury
Acute Respiratory Distress Syndrome
Procedure: Placement of an esophageal balloon measurements
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ventilator free days [ Time Frame: At 28 days ] [ Designated as safety issue: No ]
  • Markers of inflammation [ Time Frame: In first 72 hours ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: At 28, 90 and 180 days ] [ Designated as safety issue: No ]
  • Length of stay [ Time Frame: Hospital and ICU ] [ Designated as safety issue: No ]

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: EP
Ventilation directed by esophageal balloon measurements to maintain a positive trans-pulmonary pressure at end expiration
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.
Active Comparator: Control
Ventilation based on the ARDSnet low tidal volume study
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.

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
Genders Eligible for Study:   Both
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
Investigators
Principal Investigator: Daniel S Talmor, MD, MPH Beth Israel Deaconess Medical Center
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00127491     History of Changes
Other Study ID Numbers: 2004-P-000011/1; BIDMC, RO1 HL 52586
Study First Received: August 4, 2005
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

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, Adult
Acute Lung Injury
Respiratory Distress Syndrome, Newborn
Lung Injury
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries

ClinicalTrials.gov processed this record on July 29, 2014