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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Intracranial Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

bedside sonography

Intervention Type DEVICE

TCD and ONSD sonography twice a day per 2 days

Interventions

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bedside sonography

TCD and ONSD sonography twice a day per 2 days

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* invasive ICP placement

Exclusion Criteria

* cranial base fracture
* absent informed consent

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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angela amigoni

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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angela amigoni, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Padova

Locations

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