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Taking peoplePhase 1/2

Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children

Key facts

Phase
Phase 1/2

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 0 and 18 years old?

Source: NCT07193719, who can take part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
Charite University, Berlin, Germany
Trial code
NCT07193719
Record updated
15 October 2026
Original description
The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver (LVOM) is beneficial inRead full original descriptionShow less

Influence of a Personalized Lung Volume Optimization Maneuver on Lung Aeration and Cardiac Performance in Mechanically Ventilated Children

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

Inclusion: congenital heart disease; surgery with cardiopulmonary bypass.

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

CHD study:.

ClinicalTrials.gov NCT07193719