The Accuracy of Intracranial Pressure Non Invasive Measurement With Trans Cranial Doppler Versus Invasive Measurement in Pediatric Age
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 18
View:
• invasive ICP placement
Locations
Other Locations
Italy
PICU IRCSS Sant'Orsola Malpighi
NOT_YET_RECRUITING
Bologna
PICU Spedali Civili BRescia
NOT_YET_RECRUITING
Brescia
PICU Ospedale Mayer
NOT_YET_RECRUITING
Florence
PICU Ospedale Gaslini
NOT_YET_RECRUITING
Genova
PICU University Hospital Padova
RECRUITING
Padua
PICU Università Cattolica
NOT_YET_RECRUITING
Roma
Contact Information
Primary
angela amigoni, MD
angela.amigoni@aopd.veneto.it
+39 339 8333765
Time Frame
Start Date: 2022-07-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 46
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Azienda Ospedaliera di Padova