Strategies to Optimize Positive End-expiratory Pressure (PEEP) in Patients With Acute Lung Injury (EIT-PEEP)

March 29, 2011 updated by: University Hospital, Bonn

Influence of Different Strategies to Optimize Positive End-expiratory Pressure on Pulmonary Gas Exchange, Perfusion/Ventilation Matching and Homogeneity of Ventilation in Patients With Acute Lung Injury

The purpose of this study in patients suffering from acute lung injury is to determine whether positive end-expiratory pressure (PEEP) setting guided by electrical impedance tomography (EIT) influences pulmonary gas exchange, lung mechanics, ventilation/perfusion matching and homogeneity of regional ventilation when compared to other PEEP setting strategies such as the open lung concept or the ARDSnet protocol.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

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

  • Germany
      • Bonn, Germany, 53105
        • Recruiting
        • University Hospital
        • Contact:
        • Principal Investigator:
          • Thomas Muders, MD
        • Principal Investigator:
          • Christian Putensen, Prof., MD

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • acute lung injury, need for optimization of ventilatory settings

Exclusion Criteria:

  • preexisting chronical lung disease, pneumothorax, pace maker, hemodynamical instability, increased intracranial pressure

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acute Lung Injury / ARDS
Patient under mechanical suffering from ALI or ARDS
Procedure: PEEP titration
PEEP is set according to the following protocols, respectively, in a randomized order: ARDSnet table, Open Lung strategy, guided by EIT
Other Names:
  • electrical impedance tomography guided setting of PEEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
homogeneity of regional ventilation delay
Time Frame: up to eight hours
influence of different PEEP titration strategies on homogeneity of regional ventilation delay measured by electrical impedance tomography
up to eight hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pulmonary gas exchange, lung mechanics and ventilation/perfusion matching
Time Frame: up to eight hours
influence of different PEEP titration strategies on pulmonary gas exchange, lung mechanics and ventilation/perfusion matching
up to eight hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Investigators

  • Study Chair: Christian Putensen, MD, Prof, University of Bonn
  • Principal Investigator: Thomas Muders, MD, University of Bonn

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

March 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

July 15, 2010

First Submitted That Met QC Criteria

March 29, 2011

First Posted (Estimate)

March 30, 2011

Study Record Updates

Last Update Posted (Estimate)

March 30, 2011

Last Update Submitted That Met QC Criteria

March 29, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EIT-PEEP-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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