About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
invasive ICP placement
Disqualifiers
cranial base fracture
absent informed consent
Trial population
pediatric patients with planned invasive ICP admitted to PICU
Trial design
Cohort
Prospective
Treatments tested in this trial
bedside sonography
DeviceTCD and ONSD sonography twice a day per 2 days
Treatment groups
Trial outcomes
Primary outcomes
comparison between ICP and nICP (measured by TCD)
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)
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)
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)
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).
Secondary outcomes
comparison between ICP and nICP (measured by ONSD)
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.
interrater reliability for TCD measurement
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.
interrater reliability for ONSD measurement
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.
Sponsors and contacts
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