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Clinical Trials in Italy / NCT05340062
Recruiting Observational

Non Invasive Measurement With Trans Cranial Doppler Versus Invasive Measurement in Pediatric Age

NCT05340062 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2022-07-01
Last updated
2025-01-28

Condition(s) studied

Intracranial Hypertension

Investigational drug(s) / intervention(s)

bedside sonography

bedside sonography: TCD and ONSD sonography twice a day per 2 days

Study summary

An increase of intracranial pressure (ICP) is an important cause of secondary brain damage. The gold standard for measuring ICP is represented by invasive positioning of intracranial ICP devices.

The most used non-invasive methods (nICP) are obtained through bed-side ultrasound, routinely used in the management of children in Pediatric Intensive Care: arterial Trancranial Doppler (TCD) and ultrasound measurement of the diameter of the optic nerve sheath (ONSD ).

In this study it is proposed to compare the measurement of nICP obtained by TCD and ONSD versus the measurement obtained by the invasive monitoring (iICP) already present.

Eligibility

Sex
ALL
Min age
—
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * invasive ICP placement Exclusion Criteria: * cranial base fracture * absent informed consent

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
PICU IRCSS Sant'Orsola Malpighi Bologna Italy Not Yet Recruiting
PICU Spedali Civili BRescia Brescia Italy Not Yet Recruiting
PICU Ospedale Mayer Florence Italy Not Yet Recruiting
PICU Ospedale Gaslini Genova Italy Not Yet Recruiting
PICU University Hospital Padova Padova Italy Recruiting
PICU Università Cattolica Roma Italy Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05340062 on ClinicalTrials.gov ↗ ← All trials in Italy