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NCT06270485 Clinical Trial

Influence of Positive-End-Expiratory-Pressure (PEEP) on Cardiac Output in Mechanically Ventilated Children

Congenital Heart Disease Clinical Trial

— IPCOM  

Official title:
Influence of Positive-End-Expiratory-Pressure (PEEP) on Cardiac Output in Mechanically Ventilated Children

Clinical Trial Details — Status: Recruiting

Administrative data
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

Study information
Verified date May 2024
Source Charite University, Berlin, Germany
Contact Jan Clausen, MD
Phone 004917620808764
Email jan-christoph.clausen@dhzc-charite.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• PEEP
Application of different PEEP-Levels during invasive mechanical ventilation

Locations
Country Name City State
Germany Deutsches Herzzentrum der Charité Berlin
Netherlands UMCG Groningen

Sponsors (2)
Lead Sponsor Collaborator
Charite University, Berlin, Germany University Medical Center Groningen

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome
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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