Actively Recruiting

Phase 1
Phase 2
Age: 0Years - 18Years
All Genders
ID07193719

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

Age: 0Years - 18Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Post-operative Follow-up

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

Loading map...

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

Similar Trials

A 10-Minute Cardiovascular Magnetic Resonance Protocol for C...

Coronary Artery Disease

Actively Recruiting

1 location

Evaluation of Surgical Techniques and Outcomes Across the Li...

Congenital Heart Disease

Actively Recruiting

1 location

A Comprehensive Registry Study of the Whole Life Cycle of Pa...

Congenital Heart Disease

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here