nICPped: Non Invasive Measurement With Trans Cranial Doppler Versus Invasive Measurement in Pediatric Age
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- 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).
Secondary Outcome Measures
- comparison between ICP and nICP (measured by ONSD) [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.
- interrater reliability for TCD measurement [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.
- interrater reliability for ONSD measurement [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- invasive ICP placement
Exclusion Criteria:
-
cranial base fracture
-
absent informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | PICU IRCSS Sant'Orsola Malpighi | Bologna | Italy | ||
| 2 | PICU Spedali Civili BRescia | Brescia | Italy | ||
| 3 | PICU Ospedale Mayer | Firenze | Italy | ||
| 4 | PICU Ospedale Gaslini | Genova | Italy | ||
| 5 | PICU University Hospital Padova | Padova | Italy | 35128 | |
| 6 | PICU Università Cattolica | Roma | Italy |
Sponsors and Collaborators
- Azienda Ospedaliera di Padova
Investigators
- Principal Investigator: angela amigoni, MD, University Hospital of Padova
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 5210/AO/21