Monitoring and interpretation of intracranial pressure.
M Czosnyka, J D Pickard
https://pubmed.ncbi.nlm.nih.gov/15145991Actively Recruiting
Led by Azienda Ospedaliera di Padova · Updated on 2025-01-28
46
Participants Needed
6
Research Sites
26 weeks
Total Duration
Increased intracranial pressure (ICP) can cause secondary brain damage, and accurate measurement of ICP is important for managing this condition. The standard method to measure ICP involves invasive placement of intracranial devices, which can carry risks such as bleeding and infection. Researchers are studying non-invasive methods using bedside ultrasound techniques, including Transcranial Doppler (TCD) and measurement of the optic nerve sheath diameter (ONSD), to estimate ICP in children in Pediatric Intensive Care. This research compares the non-invasive ICP measurements obtained by TCD and ONSD with the invasive ICP measurements already in place for pediatric patients. Measurements will be taken within 30 minutes before invasive ICP device placement when possible, and at least twice daily for 48 hours after device placement. Each measurement includes invasive ICP and CPP calculations, TCD flow velocity assessments to estimate non-invasive CPP and ICP, and ONSD measurements, with two independent operators performing ultrasound assessments to evaluate consistency. Participants will have ultrasound assessments during their care, and researchers will collect data on invasive and non-invasive ICP measurements to compare accuracy. The study evaluates inter-operator reliability of ultrasound measurements. The primary outcome focuses on comparing ICP values measured invasively and by TCD within 48 hours after ICP device placement. The study is observational and involves children up to 18 years old who require ICP monitoring, with participation lasting at least two days of twice-daily assessments.
CONDITIONS
Non Invasive Measurement With Trans Cranial Doppler Versus Invasive Measurement in Pediatric Age
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 48 hours after ICP placement
Participants who require invasive intracranial pressure (ICP) monitoring have non-invasive measurements with Transcranial Doppler (TCD) and optic nerve sheath diameter (ONSD) sonography performed around the time of ICP device placement and during the first 48 hours after placement to compare with invasive ICP measurements.
Twice daily measurements for 2 days
Total: 6 locations
1
PICU IRCSS Sant'Orsola Malpighi
Bologna, Italy
Not Yet Recruiting
2
PICU Spedali Civili BRescia
Brescia, Italy
Not Yet Recruiting
3
PICU Ospedale Mayer
Florence, Italy
Not Yet Recruiting
4
PICU Ospedale Gaslini
Genova, Italy
Not Yet Recruiting
5
PICU University Hospital Padova
Padova, Italy, 35128
Actively Recruiting
6
PICU Università Cattolica
Roma, Italy
Not Yet Recruiting
A
angela amigoni, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
M Czosnyka, J D Pickard
https://pubmed.ncbi.nlm.nih.gov/15145991Patrick M Kochanek, Robert C Tasker, Nancy Carney...
https://pubmed.ncbi.nlm.nih.gov/30822776Richard C E Anderson, Peter Kan, Paul Klimo...
https://pubmed.ncbi.nlm.nih.gov/16206972E A Schmidt, M Czosnyka, I Gooskens...
https://pubmed.ncbi.nlm.nih.gov/11160468Ashkan Akhavan Malayeri, Shirin Bavarian, Mehrzad Mehdizadeh
https://pubmed.ncbi.nlm.nih.gov/15661943Nicole Fortier O'Brien, Karin Reuter-Rice, Mark S Wainwright...
https://pubmed.ncbi.nlm.nih.gov/33884214