Comparing non-invasive and invasive methods for measuring intracranial pressure in children
Official title: The Accuracy of Intracranial Pressure Non Invasive Measurement With Trans Cranial Doppler Versus Invasive Measurement in Pediatric Age
Run by Azienda Ospedaliera di Padova · NCT05340062 · Data updated 2026-11-12
This study is testing if non-invasive ways to measure brain pressure in kids, like ultrasound techniques, can be as accurate as the traditional invasive methods that come with risks.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 46 (estimated) |
| Sponsor | Azienda Ospedaliera di Padova Academic / other |
| Locations | 6 sites (Bologna and 5 other locations) |
| Status | Recruiting |
| Started | July 1, 2022 |
| Main results expected | June 30, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | January 28, 2025 |
| Trial ID | NCT05340062 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pediatric patients who require invasive ICP monitoring due to conditions causing increased intracranial pressure.
✕Probably not a fit
Patients with cranial base fractures or those unable to provide informed consent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to compare non-invasive methods of measuring intracranial pressure (ICP) in pediatric patients using Transcranial Doppler (TCD) and optic nerve sheath diameter (ONSD) ultrasound against the gold standard of invasive ICP monitoring. The goal is to evaluate the accuracy and reliability of these non-invasive techniques, which are routinely used in Pediatric Intensive Care Units. By assessing cerebral perfusion pressure (CPP) derived from these measurements, the study seeks to determine if non-invasive methods can effectively replace invasive procedures, which carry risks of complications such as bleeding and infection.
Why it matters
Potential benefit: If successful, this study could lead to safer, non-invasive monitoring of intracranial pressure in children, reducing the need for invasive procedures.
How similar studies have gone: Previous studies have shown promising results for non-invasive methods in adults, but this approach in pediatric populations is still being explored.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * invasive ICP placement Exclusion Criteria: * cranial base fracture * absent informed consent
Where it's running
-
PICU University Hospital Padova
Padova, Italy Recruiting -
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 Università Cattolica
Roma, Italy Not yet recruiting
Study contacts
- Principal investigator: angela amigoni, MD — University Hospital of Padova
- Study coordinator: angela amigoni, MD
- Email: angela.amigoni@aopd.veneto.it
- Phone: +39 339 8333765
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.