Strategies to Optimize Positive End-expiratory Pressure (PEEP) in Patients With Acute Lung Injury
EIT-PEEP
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
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2010
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedFirst Posted
Study publicly available on registry
March 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedMarch 30, 2011
March 1, 2011
1.8 years
July 15, 2010
March 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
pulmonary gas exchange, lung mechanics and ventilation/perfusion matching
up to eight hours
Study Arms (1)
Acute Lung Injury / ARDS
EXPERIMENTALPatient under mechanical suffering from ALI or ARDS
Interventions
PEEP is set according to the following protocols, respectively, in a randomized order: ARDSnet table, Open Lung strategy, guided by EIT
Eligibility Criteria
You may qualify if:
- acute lung injury, need for optimization of ventilatory settings
You may not qualify if:
- preexisting chronical lung disease, pneumothorax, pace maker, hemodynamical instability, increased intracranial pressure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Bonn, 53105, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Christian Putensen, MD, Prof
University of Bonn
- PRINCIPAL INVESTIGATOR
Thomas Muders, MD
University of Bonn
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 15, 2010
First Posted
March 30, 2011
Study Start
March 1, 2011
Primary Completion
December 1, 2012
Study Completion
June 1, 2013
Last Updated
March 30, 2011
Record last verified: 2011-03