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

Sponsor
Charite University, Berlin, Germany
Study ID
NCT07486167
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Cardiac Surgery
  • Cardiopulmonary Bypass
  • Children
  • Congenital Heart Disease
  • Hemodynamic Changes
  • Lung Mechanics
  • Lung Volume
  • Mechanical Ventilation
  • Peep Titration in Lung Protective Ventilation
  • Positive End-expiratory Pressure (PEEP)

Eligibility Criteria

Sex
ALL
Age
0 Days - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • End-expiratory lung volume optimization maneuver with PEEP titration — PROCEDURE
    PEEP titration (incremental/decremental) will be performed at the end of surgery to optimize lung volume and find levels of PEEP corresponding to the "best" lung compliance and "best" compromise of overdistension and collapse and "best" homogenization of tidal volume distribution assessed with EIT. PEEP levels will be applied based on individual response of patients' lung mechanics and EIT measures. Tidal volume will be kept constant at 6ml/kg in cases and controls. Driving pressures will be limited to 15cmH2O. Balance of CO2 will be guaranteed by adjusting respiratory rate.
  • Standard Care (in control arm) — PROCEDURE
    Patients will receive pressure controlled ventilation with target tidal volume of 6ml/kg and PEEP of 5cmH2O. Driving pressures are limited to 15cmH2O. No LVOM will be applied.

Study Details

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.

Key Dates

First listed
Mar 20, 2026
Start date
Sep 1, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control
    This group receives so called standard of care. This includes relatively low levels of PEEP (5cmH2O in case of planned surgery) and no standardized PEEP titration.
  • Experimental: Treatment
    This group receives an individual lung volume optimization maneuver with PEEP titration. PEEP titration is performed while monitoring lung mechanics and EIT indices of overdistension and collapse and regional tidal volume distribution to optimize end-expiratory lung volume and find final "best PEEP". If possible lung perfusion will be assessed with EIT to evaluate V/Q-matching.

Primary Outcome Measure

Cardiac Index (L/min/BSA) [ Time Frame: perioperatively ]

Central Contacts

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