Actively Recruiting
Influence of a Personalized Lung Volume Optimization Maneuver on Lung Aeration and Cardiac Performance in Mechanically Ventilated Children
Led by Charite University, Berlin, Germany · Updated on 2026-04-09
80
Participants Needed
1
Research Sites
29 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether a standardized lung volume optimization maneuver (LVOM) can improve lung function and heart performance in children. This study focuses on two groups: children undergoing heart surgery with cardiopulmonary bypass for congenital heart disease, and children with severe respiratory failure who are at risk of or require extracorporeal membrane oxygenation (ECMO). The research aims to see if optimizing lung volume affects breathing support duration, lung function, and heart stability among these patients. The trial compares two approaches: one group receives standard care with set positive end-expiratory pressure (PEEP) levels and no personalized adjustments, while the other undergoes LVOM with PEEP titration to find the best lung volume settings based on lung mechanics. In children after heart surgery, PEEP levels between 10-20 cmH2O are adjusted to improve lung compliance, while in children with respiratory failure, titration is tailored during mechanical ventilation or high-frequency oscillatory ventilation. Both groups are monitored during and after these interventions. Participants will undergo various assessments including heart function, lung mechanics, lung aeration, blood oxygenation, and ventilation-perfusion matching using imaging and physiological measurements. Researchers will track outcomes such as cardiac index and ECMO duration, as well as lung performance and hemodynamic stability. The study involves regular monitoring during the perioperative and periprocedural periods to evaluate the benefits of the lung volume optimization maneuver. The trial is expected to continue until December 2027.
CONDITIONS
Brief Title
Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children with congenital heart disease undergoing surgery with cardiopulmonary bypass
- Patients with respiratory failure on ECMO or at risk for ECMO
- Receiving invasive mechanical ventilation
You will not qualify if you...
- Single ventricle heart physiology
- Use of ECMO or ventricular assist device before study
- Gestational age less than 36 weeks
- Chronic lung disease
- Endotracheal tube leak greater than 15%
- Lack of informed consent from parents
- Severe lung hypoplasia or interstitial lung disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Perioperative period during and immediately after surgery
Participants undergo cardiac surgery with cardiopulmonary bypass and receive either a personalized lung volume optimization maneuver with PEEP titration or standard care ventilation to optimize lung function and cardiac performance while mechanically ventilated.
1 baseline visit and multiple assessments during surgery and immediate postoperative care
Duration - Up to several days after surgery as clinically indicated
Participants are monitored postoperatively for lung mechanics, hemodynamics, and cardiac performance to evaluate the effects of the lung volume optimization maneuver or standard care.
Daily visits until discharge from intensive care or hospital
Trial Site Locations
Total: 1 location
1
German Heart Center of the Charité
Berlin, Germany, 13353
Actively Recruiting
Research Team
J
Jan C Clausen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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