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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00127491
• Other study ID #: 2004P000011
• Secondary ID: R01HL052586
• Status: Completed
• Phase: N/A
• First received: August 4, 2005
• Last updated: February 24, 2017
• Start date: May 2004
• Est. completion date: May 2010

Study information

• Verified date: February 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: May 2010
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Wounds and Injuries

Intervention

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)
• Transpulmonary pressure-directed ventilation (EPVent)
Transpulmonary pressure-directed ventilation using measurements from the esophageal balloon.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Loring SH, O'Donnell CR, Behazin N, Malhotra A, Sarge T, Ritz R, Novack V, Talmor D. Esophageal pressures in acute lung injury: do they represent artifact or useful information about transpulmonary pressure, chest wall mechanics, and lung stress? J Appl Physiol (1985). 2010 Mar;108(3):515-22. doi: 10.1152/japplphysiol.00835.2009. — View Citation

Sarge T, Talmor D. Targeting transpulmonary pressure to prevent ventilator induced lung injury. Minerva Anestesiol. 2009 May;75(5):293-9. Review. — View Citation

Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygenation as measured by the PO2/FiO2 (P/F) ratio		72 hours from enrollment
Secondary	Ventilator free days		At 28 days
Secondary	Markers of inflammation		In first 72 hours
Secondary	Mortality		At 28, 90 and 180 days
Secondary	Length of stay		Hospital and ICU