Clinical trial NCT00127491: Mechanical Ventilation, Directed by Esophageal Pressure Measurements, in Patients With Acute Lung Injury
Official title: A RCT of Mechanical Ventilation, Directed by Esophageal Pressure Measurements, in Patients With Acute Lung Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lung Injury
Acute Respiratory Distress Syndrome
Keywords: Acute Lung Injury
Acute Respiratory Distress Syndrome
Mechanical Ventilation
Esophageal Pressures
Randomized Controlled Trial
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-08-08
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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 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

Primary outcomes:
measure: Oxygenation as measured by the PO2/FiO2 (P/F) ratio
timeFrame: 72 hours from enrollment
Secondary outcomes:
measure: Ventilator free days
timeFrame: At 28 days
measure: Markers of inflammation
timeFrame: In first 72 hours
measure: Mortality
timeFrame: At 28, 90 and 180 days
measure: Length of stay
timeFrame: Hospital and ICU
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Daniel S Talmor, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. Epub 2009 Dec 17.
citation: Sarge T, Talmor D. Targeting transpulmonary pressure to prevent ventilator induced lung injury. Minerva Anestesiol. 2009 May;75(5):293-9.
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. Epub 2008 Nov 11.
citation: Schaefer MS, Loring SH, Talmor D, Baedorf-Kassis EN. Comparison of mechanical power estimations in mechanically ventilated patients with ARDS: a secondary data analysis from the EPVent study. Intensive Care Med. 2021 Jan;47(1):130-132. doi: 10.1007/s00134-020-06282-1. Epub 2020 Oct 19. No abstract available.
citation: Talmor D, Sarge T, Legedza A, O'Donnell CR, Ritz R, Loring SH, Malhotra A. Cytokine release following recruitment maneuvers. Chest. 2007 Nov;132(5):1434-9. doi: 10.1378/chest.07-1551. Epub 2007 Oct 9.