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Extended neurological surveillance in congenital cardiac catheterization

Extended neurological surveillance in congenital cardiac catheterization

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00019028
Enrollment
50
Registered
2019-11-28
Start date
2019-12-03
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital heart disease

Interventions

Group 1: Children with CHD aged 0-18 years who receive analgesia with propofol as part of a clinically indicated congenital cardiac catheterization will be neurologically monitored for the duration of
continuous recording in the further course of the cardiac catheter and finally again every minute after halving the sedation and in the recovery phase after completion of sedation. Recording of proced

Sponsors

Zentrum für Kinder- und Jugendmedizin des Universitätsklinikums FreiburgKlinik III: Angeborene Herzfehler / Pädiatrische Kardiologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0 Years to 18 Years

Inclusion criteria

Inclusion criteria: Infants, Children an Adolescent 0-18 years of age; Indication for cardic catherization, written parental or legal representative consent form

Exclusion criteria

Exclusion criteria: No written consent form; history of seizures; know pathological neurologic comorbiditiy

Design outcomes

Primary

MeasureTime frame
Semiquantitative description of the variations of the electric brain activity and/or the NIRS values in connection with the procedures in cardiac catherization. On account of the small case numbers a Case-by-Case analysis is carried out first, followed by a whole analysis of all patient's data. Moreover the classical evaluation/ interpretation oft the aEEGs is applied: This contains the classification of the background activity according to Hellström Westas et al. which is generaly approved and used widespread (Hellström-Westas L, Rosén I, de Vries LS et Al. Amplitude-integrated EEG – Classification and interpretation in preterm and term infants. NeoReviews 2006; 7:e76-e87.). The evaluation of the NIRS data contains the description of the relative changes in oxygenated and desoxygenated hemoglobin as well as the cumulative hemoglobin. From these parametres the difference (Hb-Diff) can be calculated as a measure of the cerebralen blood flow. The relative changes of the tissue oxygenation index (TOI) is also considered.

Secondary

MeasureTime frame
- Can we detect seizures in the clinicaly inconspicuous patient? - Are there age differences in cerebral activitiy and/or brain tissue oxygenation? - Can we identify certain measures or interventions, that are connected to acute aEEG- or NIRS changes? - Is there prove for a suppression in electrocortical activity and a diminished cerebrle oxygen consumption under sedation with Propofol?

Countries

Germany

Contacts

Public ContactRouven Kubicki

Zentrum für Kinder- und Jugendmedizin des Universitätsklinikums Freiburg Klinik III: Angeborene Herzfehler / Pädiatrische Kardiologie

rouven.kubicki@universitaets-herzzentrum.de+49 (0) 761/270-43170

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026