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

NCT ID: NCT06270485

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-27

Study Completion Date

2024-11-22

Brief Summary

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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

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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

Conditions

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Ventilation Therapy; Complications Congenital Heart Disease Children, Only Hemodynamic Instability

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ventilated children

Application of different PEEP-levels during invasive mechanical ventilation

Group Type OTHER

PEEP

Intervention Type PROCEDURE

Application of different PEEP-Levels during invasive mechanical ventilation

Interventions

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PEEP

Application of different PEEP-Levels during invasive mechanical ventilation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* univentricular hearts
* ECMO/VAD
Minimum Eligible Age

1 Day

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Jan Clausen

Dr. med. / MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan Clausen, MD

Role: PRINCIPAL_INVESTIGATOR

Charité

Locations

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Deutsches Herzzentrum der Charité

Berlin, State of Berlin, Germany

Site Status

UMCG

Groningen, , Netherlands

Site Status

Countries

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Germany Netherlands

References

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"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

Reference Type BACKGROUND

Other Identifiers

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EA2/224/23

Identifier Type: -

Identifier Source: org_study_id

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