bedside sonography: TCD and ONSD sonography twice a day per 2 days
Study summary
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.
comparison between ICP and nICP (measured by TCD) — 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).
comparison between ICP and nICP (measured by TCD) — 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).
comparison between ICP and nICP (measured by TCD) — 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).
comparison between ICP and nICP (measured by TCD) — 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).
Trial sites (6)
Facility
City
Region
Status
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
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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