Ventilation Therapy; ComplicationsIPCOMNCT06270485
Influence of Positive-End-Expiratory-Pressure (PEEP) on Cardiac Output in Mechanically Ventilated Children
A study testing PEEP in people with Ventilation Therapy; Complications and Congenital Heart Disease, run by Charite University, Berlin, Germany at 2 sites in 2 countries.
Trial summary
Interventional Trial to determine the Effect of different PEEP levels on Cardiac output and right-ventricular function in mechanically ventilated children < 5 years of age with congenital heart disease. Read more about this study
- Who is it for?
- Ages 1 day to 5 years
- Conditions the study is for
- Ventilation Therapy; Complications, Congenital Heart Disease, Children, Only
- What is being tested?
- PEEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 27 Nov 2023to 22 Nov 2024
- Phase
- Interventional
- 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 1 day to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- invasive mechanical ventilation
- congenital heart disease (biventricular anatomy)
Who cannot join
- univentricular hearts
- ECMO/VAD
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Deutsches Herzzentrum der Charité
Berlin, State of Berlin, 13353
About this study
Interventional Trial to determine the Effect of different PEEP levels on Cardiac output and right-ventricular function in mechanically ventilated children < 5 years of age with congenital heart disease.
Read the detailed description
Different PEEP-levels will be applied during invasive mechanical ventilation to describe Cardio-pulmonary interactions in children with congenital heart disease (CHD). An additional trial with the same study protocol is planned in a cohort of children with primarily pulmonary disease without CHD after completion of this trial. Esophageal pressure-monitoring, Ultrasound, respiratory mechanics and electrical impedance tomography will be used
- Conditions
- Ventilation Therapy; Complications, Congenital Heart Disease, Children, Only, Hemodynamic Instability
- Being tested
- PEEP
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEPProcedure or surgery
Application of different PEEP-Levels during invasive mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| ventilated children | Other | Application of different PEEP-levels during invasive mechanical ventilation Receives: Procedure: PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output
change in CO during intervention
Measured: 1 year
Secondary outcomes (7)
TAPSE (cm)
Excursion of the TV annulus
Measured: 1 year
respiratory mechanics
Tidal Volume (ml/kg)
Measured: 1 year
TAPSV (cm/s)
systolic excursion of the TV annulus with tissue doppler
Measured: 1year
Global Strain RV (%/sec)
shortening of the RV myocardium during systole
Measured: 1year
Lung Compliance (ml/Min/kg)
compliance of lung tissue
Measured: 1year
Esophageal Pressure (mbar)
monitoring with balloon
Measured: 1year
EIT
Tidal Volume distribution
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start27 Nov 2023
- Primary completion15 Jul 2024
- Study completion22 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventilation Therapy; ComplicationsStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen
- Responsible party
- Principal investigator, Jan Clausen, Charite University, Berlin, Germany
- Investigators
- Jan Clausen, MD, Principal investigator, Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270485
- Sponsor's protocol ID
- EA2/224/23
- Acronym
- IPCOM
- Status last verified
- Apr 2026
- First submitted
- 2 Feb 2024
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Clausen JC, Emeis M, Hollander R, Miera O, Kleine-Brueggeney M, Blokpoel RGT, Garfias-Veitl T, Asendorf T, Vadiunec VV, Photiadis J, Berger F, Kneyber MCJ. Effect of Positive End-Expiratory Pressure on Cardiac Index and Right Ventricular Performance in Ventilated Children Post-Cardiac Surgery. Pediatr Crit Care Med. 2026 Feb 1;27(2):176-186. doi: 10.1097/PCC.0000000000003880. Epub 2025 Dec 19.
PubMed 41416857"Electrical impedance tomography during open heart surgery and on the cardiac icu is feasible to monitor ventilation in children with congenital heart disease" J.-C. Clausen, M. Emeis, M. Kleine-Brueggeney, M.-Y. Cho, M. Kneyber and O. Miera Intensive Care Medicine - Paediatric and Neonatal 2024 Vol. 2 Issue 1 Pages 19 DOI: 10.1007/s44253-024-00043-4
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Positive-End-Expiratory-Pressure (PEEP) on Cardiac Output in Mechanically Ventilated Children
- ClinicalTrials.gov ID
- NCT06270485
- Acronym / sponsor ID
- IPCOM / EA2/224/23
- Conditions
- Ventilation Therapy; Complications, Congenital Heart Disease, Children, Only, Hemodynamic Instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- University Medical Center Groningen
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 21 Feb 2024 (actual)
- 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.
Interventional Trial to determine the Effect of different PEEP levels on Cardiac output and right-ventricular function in mechanically ventilated children < 5 years of age with congenital heart disease.
Detailed description
Different PEEP-levels will be applied during invasive mechanical ventilation to describe Cardio-pulmonary interactions in children with congenital heart disease (CHD). An additional trial with the same study protocol is planned in a cohort of children with primarily pulmonary disease without CHD after completion of this trial. Esophageal pressure-monitoring, Ultrasound, respiratory mechanics and electrical impedance tomography will be used
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ventilated children | Other | Procedure: PEEPApplication of different PEEP-levels during invasive mechanical ventilation |
Who may qualify
- Ages
- 1 day to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- invasive mechanical ventilation
- congenital heart disease (biventricular anatomy)
Key exclusion criteria (2 listed)
- univentricular hearts
- ECMO/VAD
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 |
|---|---|---|
| PEEPApplication of different PEEP-Levels during invasive mechanical ventilation | Procedure or surgery | ventilated children |
Primary outcome
Cardiac Output
Time frame: 1 year
change in CO during intervention
7 secondary outcomes
TAPSE (cm)
Time frame: 1 year
respiratory mechanics
Time frame: 1 year
TAPSV (cm/s)
Time frame: 1year
Global Strain RV (%/sec)
Time frame: 1year
Lung Compliance (ml/Min/kg)
Time frame: 1year
Esophageal Pressure (mbar)
Time frame: 1year
EIT
Time frame: 1year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Results publication: PubMed 41416857Clausen JC, Emeis M, Hollander R, Miera O, Kleine-Brueggeney M, Blokpoel RGT, Garfias-Veitl T, Asendorf T, Vadiunec VV, Photiadis J, Berger F, Kneyber MCJ. Effect of Positive End-Expiratory Pressure on Cardiac Index and Right Ventricular Performance in Ventilated Children Post-Cardiac Surgery. Pediatr Crit Care Med. 2026 Feb 1;27(2):176-186. doi: 10.1097/PCC.0000000000003880. Epub 2025 Dec 19.
- Results publication"Electrical impedance tomography during open heart surgery and on the cardiac icu is feasible to monitor ventilation in children with congenital heart disease" J.-C. Clausen, M. Emeis, M. Kleine-Brueggeney, M.-Y. Cho, M. Kneyber and O. Miera Intensive Care Medicine - Paediatric and Neonatal 2024 Vol. 2 Issue 1 Pages 19 DOI: 10.1007/s44253-024-00043-4
- Individual participant dataSharing planned: Undecided
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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.
Jan Clausen, MD principal investigator
Charité
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP in people with Ventilation Therapy; Complications and Congenital Heart Disease, run by Charite University, Berlin, Germany at 2 sites in 2 countries.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Netherlands. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Output (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06270485, which also lists 2 linked publications.
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 21 Apr 2026.