Influence of Positive-End-Expiratory-Pressure (PEEP) on Cardiac Output in Mechanically Ventilated Children (IPCOM)

April 16, 2026 updated by: Jan Clausen, Charite University, Berlin, Germany
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • State of Berlin
      • Berlin, State of Berlin, Germany, 13353
        • Deutsches Herzzentrum der Charite
  • Netherlands
      • Groningen, Netherlands
        • UMCG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • invasive mechanical ventilation
  • congenital heart disease (biventricular anatomy)

Exclusion Criteria:

  • univentricular hearts
  • ECMO/VAD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ventilated children
Application of different PEEP-levels during invasive mechanical ventilation
Procedure: PEEP
Application of different PEEP-Levels during invasive mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac Output
Time Frame: 1 year
change in CO during intervention
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TAPSE (cm)
Time Frame: 1 year
Excursion of the TV annulus
1 year
respiratory mechanics
Time Frame: 1 year
Tidal Volume (ml/kg)
1 year
TAPSV (cm/s)
Time Frame: 1year
systolic excursion of the TV annulus with tissue doppler
1year
Global Strain RV (%/sec)
Time Frame: 1year
shortening of the RV myocardium during systole
1year
Lung Compliance (ml/Min/kg)
Time Frame: 1year
compliance of lung tissue
1year
Esophageal Pressure (mbar)
Time Frame: 1year
monitoring with balloon
1year
EIT
Time Frame: 1year
Tidal Volume distribution
1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

University Medical Center Groningen

Investigators

  • Principal Investigator: Jan Clausen, MD, Charité

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2023

Primary Completion (Actual)

July 15, 2024

Study Completion (Actual)

November 22, 2024

Study Registration Dates

First Submitted

February 2, 2024

First Submitted That Met QC Criteria

February 18, 2024

First Posted (Actual)

February 21, 2024

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA2/224/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Congenital Heart Disease

Clinical Trials on PEEP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe