Actively Recruiting

Age: 0 - 18Years
All Genders
ID05340062

The Accuracy of Intracranial Pressure Non Invasive Measurement Using Transcranial Doppler Versus Invasive Measurement in Pediatric Patients

Led by Azienda Ospedaliera di Padova · Updated on 2025-01-28

46

Participants Needed

6

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

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

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Invasive intracranial pressure (ICP) monitoring device placement
Not Eligible

You will not qualify if you...

  • Cranial base fracture
  • Absence of informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

Trial Site Locations

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

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Research Team

A

angela amigoni, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Guidelines for the Management of Pediatric Severe Traumatic Brain Injury, Third Edition: Update of the Brain Trauma Foundation Guidelines, Executive Summary.

Patrick M Kochanek, Robert C Tasker, Nancy Carney...

https://pubmed.ncbi.nlm.nih.gov/30822776

Practice Recommendations for Transcranial Doppler Ultrasonography in Critically Ill Children in the Pediatric Intensive Care Unit: A Multidisciplinary Expert Consensus Statement.

Nicole Fortier O'Brien, Karin Reuter-Rice, Mark S Wainwright...

https://pubmed.ncbi.nlm.nih.gov/33884214