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

Not Applicable

Active, not recruiting

• Conditions: Children, Only; Congenital Heart Disease; Hemodynamic Instability; Ventilation Therapy; Complications
• Interventions: Procedure: PEEP

• Registration Number: NCT06270485
• Lead Sponsor: Charite University, Berlin, Germany

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

Study Timeline

• Study Start: 2023-11-27
• Study First Submitted: 2024-02-02
• Study First Submitted QC: 2024-02-18
• Study First Posted: 2024-02-21
• Status Verified: 2024-06
• Primary Completion: 2024-06-13
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• invasive mechanical ventilation
• congenital heart disease (biventricular anatomy)

Exclusion Criteria

• univentricular hearts
• ECMO/VAD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ventilated children	PEEP	Application of different PEEP-levels during invasive mechanical ventilation

Primary Outcome Measures

Name	Time	Method
Cardiac Output	1 year	change in CO during intervention

Secondary Outcome Measures

Name	Time	Method
TAPSV (cm/s)	1year	systolic excursion of the TV annulus with tissue doppler
respiratory mechanics	1 year	Tidal Volume (ml/kg)
Global Strain RV (%/sec)	1year	shortening of the RV myocardium during systole
TAPSE (cm)	1 year	Excursion of the TV annulus
Lung Compliance (ml/Min/kg)	1year	compliance of lung tissue
EIT	1year	Tidal Volume distribution
Esophageal Pressure (mbar)	1year	monitoring with balloon

Trial Locations

Locations (2)

Deutsches Herzzentrum der Charité; 🇩🇪 Berlin, Germany

UMCG; 🇳🇱 Groningen, Netherlands