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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of Schleswig-Holstein.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01107847
First received: April 19, 2010
Last updated: April 20, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention
Acute Lung Injury
 Procedure: low flow pressure volume manoeuvre

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Measurement of Regional Lung Opening and Closing Pressures in Patients With Acute Lung Injury Using Electrical Impedance Tomography

Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • Measurement of regional lung opening pressures [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Measurement of regional closing pressures [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 25
Intervention Details:
    Procedure: low flow pressure volume manoeuvre
    In all patients a standard low flow pressure volume manoeuvre is applied by a respirator with a constant gas flow of 4 l/min starting at a zero end-expiratory pressure up to a tidal volume of 2 l or until a maximum airway pressure of 35 cm H2O was reached.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107847

Contacts
Contact: Sven Pulletz, M.D. +49 431 597 2991 pulletz@anaesthesie.uni-kiel.de

Locations
Germany
Department of Anesthesiology and Intensive Care Medicine, University Medical Center of Schleswig-Holstein, Campus Kiel Recruiting
Kiel, Germany, 24105
Contact: Sven Pulletz, M.D.     + 49 431 597 2991     pulletz@anaesthesie.uni-kiel.de    
Contact: Inéz Frerichs, M.D.     + 49 431 597 2991     frerichs@anaesthesie.uni-kiel.de    
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.            
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Study Chair: Jens Scholz, M.D. University Medical Center of Schleswig-Holstein, Campus Kiel, Department of Anesthesiology and Intensive Care Medicine
  More Information

Publications:

Responsible Party: Prof. Dr. Jens Scholz, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT01107847     History of Changes
Other Study ID Numbers: UKSH ROP/RCP
Study First Received: April 19, 2010
Last Updated: April 20, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University of Schleswig-Holstein:
electrical impedance tomography
EIT
acute lung injury
regional lung opening pressure
regional lung closing pressure

Additional relevant MeSH terms:
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Injury
Lung Diseases
 Respiratory Tract Diseases
Respiration Disorders
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 19, 2013