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

ConditionsCongenital Heart DiseaseCardiopulmonary BypassMechanical VentilationPeep Titration in Lung Protective VentilationPositive End-expiratory Pressure (PEEP)Lung VolumeLung MechanicsChildrenHemodynamic ChangesCardiac Surgery
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age0-18
SponsorCharite University, Berlin, Germany

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Inclusion Criteria

congenital heart disease

surgery with cardiopulmonary bypass

Disqualifiers

single ventricle physiology

ECMO/VAD

<36weeks of gestational age

chronic lung disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • End-expiratory lung volume optimization maneuver with PEEP titration

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cardiac Index (L/min/BSA)

assessed by using POCUS

Time frame
perioperatively

Secondary outcomes

1

lung mechanics

lung compliance (ml/cmH2O/kg)

Time frame
perioperatively
2

right ventricular performance

TAPSE PAAT Strain

Time frame
perioperatively
3

ventilation distribution

EIT

Time frame
perioperatively
4

lung perfurision

EIT

Time frame
perioperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Charite University, Berlin, Germany

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: