Acute Lung InjuryPhase 2EIT-PEEPNCT01326208
Strategies to Optimize Positive End-expiratory Pressure (PEEP) in Patients With Acute Lung Injury
A Phase 2 study testing PEEP titration in people with Acute Lung Injury and Acute Respiratory Distress Syndrome, run by University Hospital, Bonn at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Lung Injury, Acute Respiratory Distress Syndrome, Respiratory Failure
- What is being tested?
- PEEP titration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute lung injury, need for optimization of ventilatory settings
Who cannot join
- preexisting chronical lung disease, pneumothorax, pace maker, hemodynamical instability, increased intracranial pressure
Trial locations and contacts
1 site in 1 country.
Thomas Muders, MD contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital
Bonn, 53105
Christian Putensen, Prof., MD, +49-228-28714119, christian.putensen@ukb.uni-bonn.de
Thomas Muders, MD
About this study
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
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.
- Being tested
- PEEP titration
- Keywords
- electrical impedance tomography, positive end-expiratory pressure, regional ventilation delay index
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP titrationProcedure or surgery
Also called electrical impedance tomography guided setting of PEEP
PEEP is set according to the following protocols, respectively, in a randomized order: ARDSnet table, Open Lung strategy, guided by EIT
| Study group | Role | What they receive |
|---|---|---|
| Acute Lung Injury / ARDS | Experimental | Patient under mechanical suffering from ALI or ARDS Receives: Procedure: PEEP titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
homogeneity of regional ventilation delay
influence of different PEEP titration strategies on homogeneity of regional ventilation delay measured by electrical impedance tomography
Measured: up to eight hours
Secondary outcomes (1)
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
Measured: up to eight hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Investigators
- Christian Putensen, MD, Prof, Study chair, University of BonnThomas Muders, MD, Principal investigator, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326208
- Sponsor's protocol ID
- EIT-PEEP-2010
- Acronym
- EIT-PEEP
- Status last verified
- Mar 2011
- First submitted
- 15 Jul 2010
- Last updated
- 30 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01326208
- Acronym / sponsor ID
- EIT-PEEP / EIT-PEEP-2010
- Keywords
- electrical impedance tomography, positive end-expiratory pressure, regional ventilation delay index
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 30 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Lung Injury / ARDS | Experimental | Procedure: PEEP titrationPatient under mechanical suffering from ALI or ARDS |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- acute lung injury, need for optimization of ventilatory settings
Key exclusion criteria (1 listed)
- preexisting chronical lung disease, pneumothorax, pace maker, hemodynamical instability, increased intracranial pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEEP titrationAlso: electrical impedance tomography guided setting of PEEPPEEP is set according to the following protocols, respectively, in a randomized order: ARDSnet table, Open Lung strategy, guided by EIT | Procedure or surgery | Acute Lung Injury / ARDS |
Primary outcome
homogeneity of regional ventilation delay
Time frame: up to eight hours
influence of different PEEP titration strategies on homogeneity of regional ventilation delay measured by electrical impedance tomography
1 secondary outcome
pulmonary gas exchange, lung mechanics and ventilation/perfusion matching
Time frame: up to eight hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Muders, MD contact
Christian Putensen, MD, Prof study chair
University of Bonn
Thomas Muders, MD principal investigator
University of Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEEP titration in people with Acute Lung Injury and Acute Respiratory Distress Syndrome, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Putensen, Prof., MD (+49-228-28714119, christian.putensen@ukb.uni-bonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
homogeneity of regional ventilation delay (time frame: up to eight hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2011; AzTrials last refreshed its copy on 7 Nov 2026.