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NCT01326208 Clinical Trial

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

Acute Respiratory Distress Syndrome Clinical Trial

— EIT-PEEP  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01326208
Other study ID # EIT-PEEP-2010
Secondary ID
Status Recruiting
Phase Phase 2
First received July 15, 2010
Last updated March 29, 2011
Start date March 2011
Est. completion date June 2013

Study information
Verified date March 2011
Source University Hospital, Bonn
Contact Christian Putensen, Prof., MD
Phone +49-228-28714119
Email christian.putensen@ukb.uni-bonn.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date June 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• PEEP titration
PEEP is set according to the following protocols, respectively, in a randomized order: ARDSnet table, Open Lung strategy, guided by EIT

Locations
Country Name City State
Germany University Hospital Bonn

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary homogeneity of regional ventilation delay influence of different PEEP titration strategies on homogeneity of regional ventilation delay measured by electrical impedance tomography up to eight hours No
Secondary pulmonary gas exchange, lung mechanics and ventilation/perfusion matching influence of different PEEP titration strategies on pulmonary gas exchange, lung mechanics and ventilation/perfusion matching up to eight hours No
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