Non Invasive Measurement With Trans Cranial Doppler Versus Invasive Measurement in Pediatric Age (nICPped)

January 27, 2025 updated by: angela amigoni, Azienda Ospedaliera di Padova

The Accuracy of Intracranial Pressure Non Invasive Measurement With Trans Cranial Doppler Versus Invasive Measurement in Pediatric Age

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

An iIncrease in intracranial pressure (ICP) is an important cause of secondary brain damage. The cerebral perfusion pressure (CPP), defined as the mean arterial pressure value (MAP) minus the ICP value (CPP = MAP-ICP), represents the pressure gradient that is responsible for cerebral flow. The gold standard for measuring ICP is represented by invasive methods that are intra-parenchymal or intra-ventricular catheters positions by neurosurgeons. The placement of these catheters can cause complications, mainly bleeding and infections.

The most used non-invasive (nICP) methods are obtained through a medical device such as 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 ).

Arterial TCD is one of the most studied methods in adults for the non-invasive estimation of ICP. Formulas derived from the measurement of cerebral flow velocities (VF) such as the Pulsatility Index (PI) and the formula based on the Diastolic Flow Rate (FVdICP) have been shown to have a correlation with the iICP. According to the literature, a PI> 1 is associated with an ICP value> 20 mmHg. Schmitd, Czosnyka et al. subsequently proposed a new formula for the non-invasive measurement of CPP and therefore of ICP (FVdICP), demonstrating the accuracy of CPP measured with the invasive technique The ONSD is a rapid and repeatable method for making a rapid diagnosis of increased ICP not only in adults but also in children, considering the diameter of the optic nerve sheath equal to 4.5 mm in children as the upper limit of the norm. 1 year of age and 4 mm in children under 1 year.

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

Study Type

Observational

Enrollment (Estimated)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bologna, Italy
        • Not yet recruiting
        • PICU IRCSS Sant'Orsola Malpighi
        • Contact:
          • matilde santià
        • Sub-Investigator:
          • fabio caramelli
      • Brescia, Italy
        • Not yet recruiting
        • PICU Spedali Civili BRescia
        • Contact:
          • diego franchini
      • Firenze, Italy
        • Not yet recruiting
        • PICU Ospedale Mayer
        • Contact:
          • francesca melosi
        • Sub-Investigator:
          • denise colosimo
      • Genova, Italy
        • Not yet recruiting
        • PICU Ospedale Gaslini
        • Contact:
          • stefano pezzato
        • Sub-Investigator:
          • marta fedriga
      • Padova, Italy, 35128
        • Recruiting
        • PICU University Hospital Padova
        • Contact:
        • Sub-Investigator:
          • elisa poletto
        • Sub-Investigator:
          • valentina stritoni
      • Roma, Italy
        • Not yet recruiting
        • PICU Università Cattolica
        • Contact:
          • aldo mancino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

pediatric patients with planned invasive ICP admitted to PICU

Description

Inclusion Criteria:

  • invasive ICP placement

Exclusion Criteria:

  • cranial base fracture
  • absent informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pediatric patients with ICP device

In children requiring ICP, TCD and ONSD will be measured:

  • within 30 minutes before to the placement of the ICP (if possiblel)
  • at least twice a day after placement of the invasive ICP for the first 48 hours

Each measurement will include:

  • The measure of the invasive ICP
  • Calculation of invasive CPP (invasive MAP-invasive ICP)
  • TCD: FVs, FVd, FVm, from which the nCPP will be obtained with the formula FVdICP. The nICP will be obtained from invasive MAP minus nCPP.
  • The measurement of the nICP ONSD (2) for a total of 2 measurements preferably from the side where the invasive ICP device is positioned.

Measurements (TCD and ONSD) will be done by two operators blinded by each other in order to evaluate the inter-operator variability
Device: bedside sonography
TCD and ONSD sonography twice a day per 2 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison between ICP and nICP (measured by TCD)
Time Frame: within 48 hours after the invasive ICP placement
For each patient with invasive ICP, the nICP (measured by TCD) will be compared. We will collect ICP and nICP in pairs for each measurement ( T1 ) using the same unit of measurement. (During 48 hours we will collect ICP and nICP in pairs 4 times: T1 T2 T3 T4. We will finally evaluate the data in pairs in the total sample).
within 48 hours after the invasive ICP placement
comparison between ICP and nICP (measured by TCD)
Time Frame: within 48 hours after the invasive ICP placement
For each patient with invasive ICP, the nICP (measured by TCD) will be compared. We will collect ICP and nICP in pairs for each measurement ( T2 ) using the same unit of measurement. (During 48 hours we will collect ICP and nICP in pairs 4 times: T1 T2 T3 T4. We will finally evaluate the data in pairs in the total sample).
within 48 hours after the invasive ICP placement
comparison between ICP and nICP (measured by TCD)
Time Frame: within 48 hours after the invasive ICP placement
For each patient with invasive ICP, the nICP (measured by TCD) will be compared. We will collect ICP and nICP in pairs for each measurement ( T3 ) using the same unit of measurement. (During 48 hours we will collect ICP and nICP in pairs 4 times: T1 T2 T3 T4. We will finally evaluate the data in pairs in the total sample).
within 48 hours after the invasive ICP placement
comparison between ICP and nICP (measured by TCD)
Time Frame: within 48 hours after the invasive ICP placement
For each patient with invasive ICP, the nICP (measured by TCD) will be compared. We will collect ICP and nICP in pairs for each measurement ( T4 ) using the same unit of measurement. (During 48 hours we will collect ICP and nICP in pairs 4 times: T1 T2 T3 T4. We will finally evaluate the data in pairs in the total sample).
within 48 hours after the invasive ICP placement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison between ICP and nICP (measured by ONSD)
Time Frame: within 48 hours after the invasive ICP placement
For each patient with invasive ICP, the nICP (measured by ONSD) will be compared twice a day for 2 days. We will collect ICP and nICP in pairs for each measurement (4 times: T1 T2 T3 T4) using the same unit of measurement and evaluate the data in pairs in the total sample.
within 48 hours after the invasive ICP placement
interrater reliability for TCD measurement
Time Frame: within 48 hours after the invasive ICP placement
For each patient with invasive ICP, two nICP measurement by TCD will be performed by two operators blinded each other. We will collect nICP values in pairs (by two operators) for each measurement (2 times) using the same unit of measurement and evaluate the data in pairs in the total sample.
within 48 hours after the invasive ICP placement
interrater reliability for ONSD measurement
Time Frame: within 48 hours after the invasive ICP placement
For each patient with invasive ICP, two nICP measurement by ONSD will be performed by two operators blinded each other. We will collect nICP values in pairs (by two operators) for each measurement (2 times) using the same unit of measurement and evaluate the data in pairs in the total sample.
within 48 hours after the invasive ICP placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera di Padova

Investigators

  • Principal Investigator: angela amigoni, MD, University Hospital of Padova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 31, 2022

First Submitted That Met QC Criteria

April 20, 2022

First Posted (Actual)

April 21, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5210/AO/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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