Children, Only, Congenital Heart Disease, Hemodynamic Instability, Ventilation Therapy; Complications
Conditions
Brief 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.
Detailed 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
Interventions
PROCEDUREPEEP
Application of different PEEP-Levels during invasive mechanical ventilation
Sponsors
Charite University, Berlin, Germany
University Medical Center Groningen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 5 Years
Healthy volunteers
No
Inclusion criteria
* invasive mechanical ventilation * congenital heart disease (biventricular anatomy)
Exclusion criteria
* univentricular hearts * ECMO/VAD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Output | 1 year | change in CO during intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TAPSE (cm) | 1 year | Excursion of the TV annulus |
| respiratory mechanics | 1 year | Tidal Volume (ml/kg) |
| TAPSV (cm/s) | 1year | systolic excursion of the TV annulus with tissue doppler |
| Global Strain RV (%/sec) | 1year | shortening of the RV myocardium during systole |
| Lung Compliance (ml/Min/kg) | 1year | compliance of lung tissue |
| Esophageal Pressure (mbar) | 1year | monitoring with balloon |
| EIT | 1year | Tidal Volume distribution |
Countries
Germany, Netherlands
Contacts
PRINCIPAL_INVESTIGATORJan Clausen, MD
Charité
Outcome results
None listed