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| Name | Class |
|---|---|
| University Medical Center Groningen | OTHER |
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Interventional Trial to determine the Effect of different PEEP levels on Cardiac output and right-ventricular function in mechanically ventilated children < 5 years of age with congenital heart disease.
Different PEEP-levels will be applied during invasive mechanical ventilation to describe Cardio-pulmonary interactions in children with congenital heart disease (CHD). An additional trial with the same study protocol is planned in a cohort of children with primarily pulmonary disease without CHD after completion of this trial. Esophageal pressure-monitoring, Ultrasound, respiratory mechanics and electrical impedance tomography will be used
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ventilated children | Other | Application of different PEEP-levels during invasive mechanical ventilation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEEP | Procedure | Application of different PEEP-Levels during invasive mechanical ventilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Output | change in CO during intervention | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| TAPSE (cm) | Excursion of the TV annulus | 1 year |
| respiratory mechanics | Tidal Volume (ml/kg) | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Clausen, MD | Charité | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum der Charité | Berlin | State of Berlin | 13353 | Germany | ||
| UMCG |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41416857 | Result | Clausen JC, Emeis M, Hollander R, Miera O, Kleine-Brueggeney M, Blokpoel RGT, Garfias-Veitl T, Asendorf T, Vadiunec VV, Photiadis J, Berger F, Kneyber MCJ. Effect of Positive End-Expiratory Pressure on Cardiac Index and Right Ventricular Performance in Ventilated Children Post-Cardiac Surgery. Pediatr Crit Care Med. 2026 Feb 1;27(2):176-186. doi: 10.1097/PCC.0000000000003880. Epub 2025 Dec 19. | |
| Result | "Electrical impedance tomography during open heart surgery and on the cardiac icu is feasible to monitor ventilation in children with congenital heart disease" J.-C. Clausen, M. Emeis, M. Kleine-Brueggeney, M.-Y. Cho, M. Kneyber and O. Miera Intensive Care Medicine - Paediatric and Neonatal 2024 Vol. 2 Issue 1 Pages 19 DOI: 10.1007/s44253-024-00043-4 |
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| TAPSV (cm/s) | systolic excursion of the TV annulus with tissue doppler | 1year |
| Global Strain RV (%/sec) | shortening of the RV myocardium during systole | 1year |
| Lung Compliance (ml/Min/kg) | compliance of lung tissue | 1year |
| Esophageal Pressure (mbar) | monitoring with balloon | 1year |
| EIT | Tidal Volume distribution | 1year |
| Groningen |
| Netherlands |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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