Mechanical Ventilation, Directed by Esophageal Pressure Measurements, in Patients With Acute Lung Injury
February 24, 2017 updated by: Daniel Talmor, Beth Israel Deaconess Medical Center
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).
Study Overview
Status
Completed
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.
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
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.
|
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.
Low tidal volume ventilation strategy (ARDSnet)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Oxygenation as measured by the PO2/FiO2 (P/F) ratio
Time Frame: 72 hours from enrollment
|
72 hours from enrollment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Ventilator free days
Time Frame: At 28 days
|
At 28 days
|
|
Markers of inflammation
Time Frame: In first 72 hours
|
In first 72 hours
|
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Mortality
Time Frame: At 28, 90 and 180 days
|
At 28, 90 and 180 days
|
|
Length of stay
Time Frame: Hospital and ICU
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Hospital and ICU
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Daniel S Talmor, MD, MPH, Beth Israel Deaconess Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Sarge T, Talmor D. Targeting transpulmonary pressure to prevent ventilator induced lung injury. Minerva Anestesiol. 2009 May;75(5):293-9.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2004
Primary Completion (Actual)
August 1, 2007
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
August 4, 2005
First Submitted That Met QC Criteria
August 4, 2005
First Posted (Estimate)
August 8, 2005
Study Record Updates
Last Update Posted (Actual)
February 27, 2017
Last Update Submitted That Met QC Criteria
February 24, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004P000011
- R01HL052586 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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