Personalized lung volume optimization with PEEP titration for children after heart surgery or with severe respiratory failure
Official title: Influence of a Personalized Lung Volume Optimization Maneuver on Lung Aeration and Cardiac Performance in Mechanically Ventilated Children
Run by Charite University, Berlin, Germany · NCT07193719 · Data updated 2026-11-12
This trial tests whether a personalized lung volume optimization maneuver using PEEP titration can improve heart and lung function in children after cardiopulmonary bypass surgery or in those with severe respiratory failure at risk for ECMO.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 0 Years to 18 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Tübingen) |
| Status | Recruiting |
| Started | December 5, 2025 |
| Main results expected | May 31, 2027 |
| Study ends | December 20, 2027 |
| Registry record updated | October 15, 2026 |
| Trial ID | NCT07193719 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children undergoing biventricular congenital heart surgery with cardiopulmonary bypass or invasively ventilated pediatric patients with severe respiratory failure who are at risk for or receiving ECMO.
✕Probably not a fit
Children with single-ventricle physiology, chronic lung disease, severe lung hypoplasia or interstitial lung disease, significant endotracheal tube leaks, or those on ECMO/VAD at baseline are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized interventional Phase 1/2 study enrolls two pediatric groups: children undergoing biventricular congenital heart surgery with cardiopulmonary bypass and children with severe respiratory failure who are on or at risk for ECMO. Participants are randomized to a standardized lung volume optimization maneuver with individualized PEEP titration versus standard care, with post-cardiac surgery measurements performed under closed-chest conditions. Investigators will record hemodynamics, lung mechanics, gas exchange, lung compliance, duration of mechanical ventilation, vasopressor use, and regional aeration/ventilation-perfusion matching using electrical impedance tomography (EIT) before and after the maneuver. The ECMO cohort will also be assessed for facilitation of lung-protective ventilation according to PALICC-2 guidelines.
Why it matters
Potential benefit: If successful, the maneuver could improve lung aeration and gas exchange, enhance cardiac performance, and shorten the duration of mechanical ventilation in these children.
How similar studies have gone: Prior adult and pediatric studies of recruitment maneuvers and PEEP titration have produced mixed results, and evidence is limited specifically for post-cardiac surgery and pediatric ECMO-risk populations.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Unviersity of Tuebingen, PICU
Tübingen, Germany Recruiting
Study contacts
- Study coordinator: Jan C Clausen, MD
- Email: jan.clausen@posteo.de
- Phone: 004970712984751
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.