Regional Lung Opening and Closing Pressures in Patients With Acute Lung Injury

April 20, 2010 updated by: University Hospital Schleswig-Holstein

Measurement of Regional Lung Opening and Closing Pressures in Patients With Acute Lung Injury Using Electrical Impedance Tomography

The purpose of this study is the measurement of regional opening and closing pressures of lung tissue by electrical impedance tomography in lung healthy and patients with acute lung injury. These values might help the setting of positive endexpiratory pressure during artificial ventilation to avoid the cyclic opening and closing of alveoli.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

During artificial ventilation the cyclic opening and closing of alveoli during artificial ventilation results in patients with acute lung injury (ALI) in a higher mortality. A positive endexpiratory pressure (PEEP) is applied with the intention to avoid these cyclic opening and closing of alveoli. The distribution of ventilation in patients with ALI is extremely inhomogeneous, consequently there are different regional opening pressures needed to open up the alveoli and avoid closing. Finding the best level of PEEP in patients with injured lungs to avoid atelectasis and alveolar strain induced by inadequately high or low PEEP levels is a challenge.

The purpose of this study is to develop a protocol for measuring regional opening and closing pressures using the method of electrical impedance tomography in lung healthy and ALI patients. A ventilator setting guided by regional opening and closing pressures might help reducing the impairment of the lung by artificial ventilation.

Study Type

Interventional

Enrollment (Anticipated)

25

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 Contact

Study Locations

  • Germany
      • Kiel, Germany, 24105
        • Recruiting
        • Department of Anesthesiology and Intensive Care Medicine, University Medical Center of Schleswig-Holstein, Campus Kiel
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sven Pulletz, M.D.
        • Sub-Investigator:
          • Matthias Kott, M.D.
        • Sub-Investigator:
          • Gunnar Elke, M.D.
        • Sub-Investigator:
          • Dirk Schaedler, M.D.
        • Sub-Investigator:
          • Guenther Zick, M.D.
        • Sub-Investigator:
          • Barbara Gawelczyk, M.D.
        • Principal Investigator:
          • Norbert Weiler, M.D.

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:

  • artificial ventilation
  • acute lung injury / healthy lung (control group)

Exclusion Criteria:

  • pregnancy
  • Cerebral trauma / surgery
  • Age < 18 years
  • instable cardiovascular disease
  • instable chest wall

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: Diagnostic
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of regional lung opening pressures
Time Frame: one year
For the measurement of regional opening pressures in lung healthy and acute lung injury an inspiratory low flow manoeuvre with synchronous measurement of regional ventilation and airway pressure is performed. The regional opening pressures are defined as the airway pressure to the point were the regional lung areas open up.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of regional closing pressures
Time Frame: one year
For the measurement of regional closing pressures in lung healthy and acute lung injury an expiratory low flow manoeuvre with synchronous measurement of regional ventilation and airway pressure is performed. The regional closing pressures are defined as the airway pressure to the point were the regional lung areas start closing.
one year

Collaborators and Investigators

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

Sponsor

University Hospital Schleswig-Holstein

Investigators

  • Study Chair: Jens Scholz, M.D., University Medical Center of Schleswig-Holstein, Campus Kiel, Department of Anesthesiology and Intensive Care Medicine

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

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 Registration Dates

First Submitted

April 19, 2010

First Submitted That Met QC Criteria

April 20, 2010

First Posted (Estimate)

April 21, 2010

Study Record Updates

Last Update Posted (Estimate)

April 21, 2010

Last Update Submitted That Met QC Criteria

April 20, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKSH ROP/RCP

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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