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

Primary Purpose

Acute Lung Injury, Acute Respiratory Distress Syndrome, Respiratory Failure

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
PEEP titration
Sponsored by
University Hospital, Bonn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lung Injury focused on measuring electrical impedance tomography, positive end-expiratory pressure, regional ventilation delay index

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acute Lung Injury / ARDS

Arm Description

Patient under mechanical suffering from ALI or ARDS

Outcomes

Primary Outcome Measures

homogeneity of regional ventilation delay
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
influence of different PEEP titration strategies on pulmonary gas exchange, lung mechanics and ventilation/perfusion matching

Full Information

First Posted
July 15, 2010
Last Updated
March 29, 2011
Sponsor
University Hospital, Bonn
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1. Study Identification

Unique Protocol Identification Number
NCT01326208
Brief Title
Strategies to Optimize Positive End-expiratory Pressure (PEEP) in Patients With Acute Lung Injury
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Bonn

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury, Acute Respiratory Distress Syndrome, Respiratory Failure
Keywords
electrical impedance tomography, positive end-expiratory pressure, regional ventilation delay index

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acute Lung Injury / ARDS
Arm Type
Experimental
Arm Description
Patient under mechanical suffering from ALI or ARDS
Intervention Type
Procedure
Intervention Name(s)
PEEP titration
Other Intervention Name(s)
electrical impedance tomography guided setting of PEEP
Intervention Description
PEEP is set according to the following protocols, respectively, in a randomized order: ARDSnet table, Open Lung strategy, guided by EIT
Primary Outcome Measure Information:
Title
homogeneity of regional ventilation delay
Description
influence of different PEEP titration strategies on homogeneity of regional ventilation delay measured by electrical impedance tomography
Time Frame
up to eight hours
Secondary Outcome Measure Information:
Title
pulmonary gas exchange, lung mechanics and ventilation/perfusion matching
Description
influence of different PEEP titration strategies on pulmonary gas exchange, lung mechanics and ventilation/perfusion matching
Time Frame
up to eight hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Putensen, Prof., MD
Phone
+49-228-28714119
Email
christian.putensen@ukb.uni-bonn.de
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Muders, MD
Email
t.muders@uni-bonn.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Putensen, MD, Prof
Organizational Affiliation
University of Bonn
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thomas Muders, MD
Organizational Affiliation
University of Bonn
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Putensen, Prof., MD
Phone
+49-228-28714119
Email
christian.putensen@ukb.uni-bonn.de
First Name & Middle Initial & Last Name & Degree
Thomas Muders, MD
First Name & Middle Initial & Last Name & Degree
Christian Putensen, Prof., MD

12. IPD Sharing Statement

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

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