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

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

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

Treatments tested in this trial

End-expiratory lung volume optimization maneuver with PEEP titration
Standard Care (in control arm)

Treatment groups

80 Participants

are divided into 2 treatment groups

Locations

German Heart Center of the Charité13353, Berlin Germany

Sponsors and collaborators

Charite University, Berlin, Germany

Lead sponsor

Source ClinicalTrials.gov