Comparing non-invasive and invasive methods for measuring intracranial pressure in children
The Accuracy of Intracranial Pressure Non Invasive Measurement With Trans Cranial Doppler Versus Invasive Measurement in Pediatric Age
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 |
|---|---|
| Enrollment | 46 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliera di Padova Academic / other |
| Locations | 6 sites (Bologna and 5 other locations) |
| Trial ID | NCT05340062 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients who require invasive ICP monitoring due to conditions causing increased intracranial pressure.
Not a fit: Patients with cranial base fractures or those unable to provide informed consent may not benefit from this study.
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 performed: Previous studies have shown promising results for non-invasive methods in adults, but this approach in pediatric populations is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * invasive ICP placement Exclusion Criteria: * cranial base fracture * absent informed consent
Where this trial is running
Bologna and 5 other locations
- 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)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.