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

NCT ID: NCT01326208

Last Updated: 2011-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Lung Injury Acute Respiratory Distress Syndrome Respiratory Failure

Keywords

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electrical impedance tomography positive end-expiratory pressure regional ventilation delay index

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Acute Lung Injury / ARDS

Patient under mechanical suffering from ALI or ARDS

Group Type EXPERIMENTAL

PEEP titration

Intervention Type PROCEDURE

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

Interventions

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PEEP titration

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

Intervention Type PROCEDURE

Other Intervention Names

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electrical impedance tomography guided setting of PEEP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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University of Bonn, Dep. of Anesthesiology and Intensive Care Medicine

Principal Investigators

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Christian Putensen, MD, Prof

Role: STUDY_CHAIR

University of Bonn

Thomas Muders, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bonn

Locations

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University Hospital

Bonn, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Christian Putensen, Prof., MD

Role: CONTACT

Phone: +49-228-28714119

Email: [email protected]

Thomas Muders, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Christian Putensen, Prof., MD

Role: primary

Other Identifiers

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EIT-PEEP-2010

Identifier Type: -

Identifier Source: org_study_id