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Recruiting Phase 1, Phase 2 NCT07193719

Influence of Lung Volume Optimization Maneuver in Ventilated Children on Cardiac Output and Lung Compliance in Children With Congenital Heart Disease Undergoing Surgical Repair and on Prevention of Need for ECMO or Shortening of ECMO Duration in Children With Severe Respiratory Failure

Trial Parameters

Condition Congenital Heart Disease
Sponsor Charite University, Berlin, Germany
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 80
Sex ALL
Min Age 0 Years
Max Age 18 Years
Start Date 2025-12-05
Completion 2027-05-31
Interventions
End-expiratory lung volume optimization maneuver with PEEP titrationStandard Care (in control arm)

Brief Summary

The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver (LVOM) is beneficial in 1. study) children undergoing biventricular repair of their congenital heart disease (CHD) with cardiopulmonary bypass and 2. study) in children with severe respiratory failure at risk for or need for ECMO. The main questions it aims to answer are: Main hypotheses of CHD study: Does a standardized PEEP-Titration maneuver, to optimize end-expiratory lung volume improve: * cardiac performance * lung function Does it make a difference in: * length of ventilation * ventilation/perfusion mismatch of the lung * need for vasopressor support? Main hypotheses of ECMO study: Does a LVOM in children/infants with severe respiratory failure /ARDS * improve lung compliance and gas exchange * facilitate lung protective ventilation according to PALICC-2 guidelines * improve lung aeration and V/Q-matching assessed with EIT Does it make a difference in * need for ECMO * duration of ECMO runs * hemodynamics stability

Eligibility Criteria

CHD study: Inclusion Criteria * congenital heart disease * surgery with cardiopulmonary bypass Exclusion Criteria: * single ventricle physiology * ECMO/VAD * \<36weeks of gestational age * chronic lung disease * Endotracheal tube leak \> 15% * lack of informed consent from parents. ECMO study Inclusion Criteria * patients with respiratory failure on ECMO or at risk for ECMO * invasive ventilation Exclusion Criteria: \- severe lung hypoplasia or interstitial lung disease

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