NCT07193719 Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children
| NCT ID | NCT07193719 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Charite University, Berlin, Germany |
| Condition | Congenital Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-12-05 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2025-12-05 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07193719 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 18 Years, studying Congenital Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07193719 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07193719 currently recruiting?
Yes, NCT07193719 is actively recruiting participants. Contact the research team at jan.clausen@posteo.de for enrollment information.
Where is the NCT07193719 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT07193719 clinical trial?
NCT07193719 is sponsored by Charite University, Berlin, Germany. The trial plans to enroll 80 participants.