NCT00127491

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

3.3 years

First QC Date

August 4, 2005

Last Update Submit

February 24, 2017

Conditions

Acute Lung InjuryAcute Respiratory Distress Syndrome

Keywords

Acute Lung InjuryAcute Respiratory Distress SyndromeMechanical VentilationEsophageal PressuresRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Oxygenation as measured by the PO2/FiO2 (P/F) ratio

    72 hours from enrollment

Secondary Outcomes (4)

  • Ventilator free days

    At 28 days

  • Markers of inflammation

    In first 72 hours

  • Mortality

    At 28, 90 and 180 days

  • Length of stay

    Hospital and ICU

Study Arms (2)

EPVent

EXPERIMENTAL

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 measurementsOther: Transpulmonary pressure-directed ventilation (EPVent)

Control

ACTIVE COMPARATOR

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 measurementsOther: Low tidal volume ventilation

Interventions

Placement of an esophageal balloon measurementsPROCEDURE

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.

ControlEPVent
Low tidal volume ventilationOTHER

Low tidal volume ventilation strategy (ARDSnet)

Control
Transpulmonary pressure-directed ventilation (EPVent)OTHER

Transpulmonary pressure-directed ventilation using measurements from the esophageal balloon.

EPVent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (5)

  • 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.

    PMID: 20019160BACKGROUND

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

    PMID: 19412147BACKGROUND

  • 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.

    PMID: 19001507RESULT

  • 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.

    PMID: 33078240DERIVED

  • 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.

    PMID: 17925413DERIVED

MeSH Terms

Conditions

Acute Lung InjuryRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Daniel S Talmor, MD, MPH

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Edward Lowenstein Professor of Anaesthesia

Study Record Dates

First Submitted

August 4, 2005

First Posted

August 8, 2005

Study Start

May 1, 2004

Primary Completion

August 1, 2007

Study Completion

May 1, 2010

Last Updated

February 27, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)