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Completed

NCT Number: NCT06270485

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

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.

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Key information

Conditions

Ventilation Therapy; Complications Cardiovascular Abnormalities Cardiovascular Diseases Children, Only Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Hemodynamic Instability

Age range

1 day–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Deutsches Herzzentrum der Charité, Berlin, State of Berlin, Germany

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • univentricular hearts
  • ECMO/VAD

Treatment and study plan

PEEP

Procedure

Application of different PEEP-Levels during invasive mechanical ventilation

Primary outcomes

  1. Cardiac Output

    Time frame: 1 year

    change in CO during intervention

Secondary outcomes

  1. TAPSE (cm)

    Time frame: 1 year

    Excursion of the TV annulus

  2. respiratory mechanics

    Time frame: 1 year

    Tidal Volume (ml/kg)

  3. TAPSV (cm/s)

    Time frame: 1year

    systolic excursion of the TV annulus with tissue doppler

  4. Global Strain RV (%/sec)

    Time frame: 1year

    shortening of the RV myocardium during systole

  5. Lung Compliance (ml/Min/kg)

    Time frame: 1year

    compliance of lung tissue

  6. Esophageal Pressure (mbar)

    Time frame: 1year

    monitoring with balloon

  7. EIT

    Time frame: 1year

    Tidal Volume distribution

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • University Medical Center Groningen

Registry information

Acronym: IPCOM

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2024
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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