Congenital Heart Disease Clinical Trial
— IPCOMOfficial title:
Influence of Positive-End-Expiratory-Pressure (PEEP) on Cardiac Output in Mechanically Ventilated Children
NCT number | NCT06270485 |
Other study ID # | EA2/224/23 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 27, 2023 |
Est. completion date | June 2025 |
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.
Status | Recruiting |
Enrollment | 56 |
Est. completion date | June 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 5 Years |
Eligibility | Inclusion Criteria: - invasive mechanical ventilation - congenital heart disease (biventricular anatomy) Exclusion Criteria: - univentricular hearts - ECMO/VAD |
Country | Name | City | State |
---|---|---|---|
Germany | Deutsches Herzzentrum der Charité | Berlin | |
Netherlands | UMCG | Groningen |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany | University Medical Center Groningen |
Germany, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiac Output | change in CO during intervention | 1 year | |
Secondary | TAPSE (cm) | Excursion of the TV annulus | 1 year | |
Secondary | respiratory mechanics | Tidal Volume (ml/kg) | 1 year | |
Secondary | TAPSV (cm/s) | systolic excursion of the TV annulus with tissue doppler | 1year | |
Secondary | Global Strain RV (%/sec) | shortening of the RV myocardium during systole | 1year | |
Secondary | Lung Compliance (ml/Min/kg) | compliance of lung tissue | 1year | |
Secondary | Esophageal Pressure (mbar) | monitoring with balloon | 1year | |
Secondary | EIT | Tidal Volume distribution | 1year |
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