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

This study is currently recruiting participants.
Verified March 2011 by University Hospital, Bonn
Sponsor:
Information provided by:
University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT01326208
First received: July 15, 2010
Last updated: March 29, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Lung Injury
Acute Respiratory Distress Syndrome
Respiratory Failure
 Procedure: PEEP titration
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • homogeneity of regional ventilation delay [ Time Frame: up to eight hours ] [ Designated as safety issue: No ]
    influence of different PEEP titration strategies on homogeneity of regional ventilation delay measured by electrical impedance tomography


Secondary Outcome Measures:
  • pulmonary gas exchange, lung mechanics and ventilation/perfusion matching [ Time Frame: up to eight hours ] [ Designated as safety issue: No ]
    influence of different PEEP titration strategies on pulmonary gas exchange, lung mechanics and ventilation/perfusion matching


Estimated Enrollment: 40
Study Start Date: March 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: electrical impedance tomography guided setting of PEEP

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01326208

Contacts
Contact: Christian Putensen, Prof., MD +49-228-28714119 christian.putensen@ukb.uni-bonn.de
Contact: Thomas Muders, MD t.muders@uni-bonn.de

Locations
Germany
University Hospital Recruiting
Bonn, Germany, 53105
Contact: Christian Putensen, Prof., MD     +49-228-28714119     christian.putensen@ukb.uni-bonn.de    
Principal Investigator: Thomas Muders, MD            
Principal Investigator: Christian Putensen, Prof., MD            
Sponsors and Collaborators
University Hospital, Bonn
Investigators
Study Chair: Christian Putensen, MD, Prof University of Bonn, Germany
Principal Investigator: Thomas Muders, MD University of Bonn, Germany
  More Information

No publications provided

Responsible Party: Prof. Dr. Christian Putensen, University of Bonn, Dep. of Anesthesiology and Intensive Care Medicine
ClinicalTrials.gov Identifier: NCT01326208     History of Changes
Other Study ID Numbers: EIT-PEEP-2010
Study First Received: July 15, 2010
Last Updated: March 29, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital, Bonn:
electrical impedance tomography
positive end-expiratory pressure
regional ventilation delay index

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

ClinicalTrials.gov processed this record on May 21, 2013