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NCT07193719
Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children
Conditions: Congenital Heart Disease, Cardiopulmonary Bypass, Cardiac Surgery, Mechanical Ventilation, Positive End-expiratory Pressure (PEEP), Lung Volume, Lung Mechanics, Hemodynamic Changes, Children, ARDS, ECMO
Sex: All
Ages: 0 Years – 18 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 80
Sponsor: Charite University, Berlin, Germany
Location: Unviersity of Tuebingen, PICU Tübingen
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
* \ 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
Source: ClinicalTrials.gov (NCT07193719). StuddyBuddy aggregates publicly available trial information.