Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children
Recruiting
Phase 1
Phase 2
Interventional Study
Congenital Heart Disease
Cardiopulmonary Bypass
Cardiac Surgery
Mechanical Ventilation
Positive End-expiratory Pressure (PEEP)
Lung Volume
Lung Mechanics
Hemodynamic Changes
Children
ARDS
ECMO
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 0 – 18
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 80 (estimated)
- Sponsor
- Charite University, Berlin, Germany · Other
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About This Trial
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:
Ma…
Trial Locations
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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 I…
Contacts