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Not yet taking people in GermanyPhase 1/2

Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congenital Heart Disease Undergoing Surgical Repair

Key facts

Where
Tübingen, GermanySee the site
Phase
Phase 1/2

Where in Germany

  • University Hospital Tübingen, PICUTübingen, GermanyContact: Jan C Clausen, MDNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
Charite University, Berlin, Germany
Trial code
NCT07486167
Record updated
15 October 2026
Original description
The aim of this randomized interventional multi-center clinical trial is to determine whether a standardized lung volume optimization maneuver (LVOM), including PEEP titration, improves outcomes in children undergoing biventricular repair for congenital heart disease (CHD) with cardiopulmonary bypass.Read full original descriptionShow less

Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Function in Children With Congenital Heart Disease

The aim of this randomized interventional multi-center clinical trial is to determine whether a standardized lung volume optimization maneuver (LVOM), including PEEP titration, improves outcomes in children undergoing biventricular repair for congenital heart disease (CHD) with cardiopulmonary bypass.

The primary hypothesis is that optimizing end-expiratory lung volume through a standardized PEEP titration maneuver improves cardiac performance and lung function.

Secondary objectives are to evaluate whether this strategy reduces duration of mechanical ventilation, improves hemodynamics and ventilation-perfusion matching, and decreases the need for vasopressor support.

Inclusion: Inclusion Criteria; congenital heart disease; surgery with cardiopulmonary bypass.

Exclusion: chronic lung disease; <36weeks of gestational age; single ventricle physiology; ECMO/VAD; Endotracheal tube leak > 15%; lack of informed consent from parents.

ClinicalTrials.gov NCT07486167