NCT06270485

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2024

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

February 2, 2024

Last Update Submit

April 16, 2026

Conditions

Ventilation Therapy; ComplicationsCongenital Heart DiseaseChildren, OnlyHemodynamic Instability

Outcome Measures

Primary Outcomes (1)

  • Cardiac Output

    change in CO during intervention

    1 year

Secondary Outcomes (7)

  • TAPSE (cm)

    1 year

  • respiratory mechanics

    1 year

  • TAPSV (cm/s)

    1year

  • Global Strain RV (%/sec)

    1year

  • Lung Compliance (ml/Min/kg)

    1year

  • +2 more secondary outcomes

Study Arms (1)

ventilated children

OTHER

Application of different PEEP-levels during invasive mechanical ventilation

Procedure: PEEP

Interventions

PEEPPROCEDURE

Application of different PEEP-Levels during invasive mechanical ventilation

ventilated children

Eligibility Criteria

Age1 Day - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • univentricular hearts
  • ECMO/VAD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Deutsches Herzzentrum der Charité

Berlin, State of Berlin, 13353, Germany

Location

UMCG

Groningen, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 41416857RESULT

  • "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

    RESULT

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jan Clausen, MD

    Charité

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. / MD

Study Record Dates

First Submitted

February 2, 2024

First Posted

February 21, 2024

Study Start

November 27, 2023

Primary Completion

July 15, 2024

Study Completion

November 22, 2024

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

NL(1)DE(1)