Clinical trial NCT05340062: Non Invasive Measurement With Trans Cranial Doppler Versus Invasive Measurement in Pediatric Age
Official title: The Accuracy of Intracranial Pressure Non Invasive Measurement With Trans Cranial Doppler Versus Invasive Measurement in Pediatric Age
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracranial Hypertension
Keywords: intracranial hypertension
children
cerebral perfusion
Lead sponsor: Azienda Ospedaliera di Padova
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 46
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pediatric patients with planned invasive ICP admitted to PICU

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.

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.

Eligibility criteria: Inclusion Criteria:

* invasive ICP placement

Exclusion Criteria:

* cranial base fracture
* absent informed consent

Primary outcomes:
measure: comparison between ICP and nICP (measured by TCD)
timeFrame: within 48 hours after the invasive ICP placement
measure: comparison between ICP and nICP (measured by TCD)
timeFrame: within 48 hours after the invasive ICP placement
measure: comparison between ICP and nICP (measured by TCD)
timeFrame: within 48 hours after the invasive ICP placement
measure: comparison between ICP and nICP (measured by TCD)
timeFrame: within 48 hours after the invasive ICP placement
Secondary outcomes:
measure: comparison between ICP and nICP (measured by ONSD)
timeFrame: within 48 hours after the invasive ICP placement
measure: interrater reliability for TCD measurement
timeFrame: within 48 hours after the invasive ICP placement
measure: interrater reliability for ONSD measurement
timeFrame: within 48 hours after the invasive ICP placement
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: PICU IRCSS Sant'Orsola Malpighi
city: Brescia
country: Italy
facility: PICU Spedali Civili BRescia
city: Firenze
country: Italy
facility: PICU Ospedale Mayer
city: Genova
country: Italy
facility: PICU Ospedale Gaslini
city: Padova
country: Italy
facility: PICU University Hospital Padova
city: Roma
country: Italy
facility: PICU Università Cattolica
Study officials:
affiliation: University Hospital of Padova
name: angela amigoni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Czosnyka M, Pickard JD. Monitoring and interpretation of intracranial pressure. J Neurol Neurosurg Psychiatry. 2004 Jun;75(6):813-21. doi: 10.1136/jnnp.2003.033126.
citation: Kochanek PM, Tasker RC, Carney N, Totten AM, Adelson PD, Selden NR, Davis-O'Reilly C, Hart EL, Bell MJ, Bratton SL, Grant GA, Kissoon N, Reuter-Rice KE, Vavilala MS, Wainwright MS. Guidelines for the Management of Pediatric Severe Traumatic Brain Injury, Third Edition: Update of the Brain Trauma Foundation Guidelines, Executive Summary. Neurosurgery. 2019 Jun 1;84(6):1169-1178. doi: 10.1093/neuros/nyz051.
citation: Anderson RC, Kan P, Klimo P, Brockmeyer DL, Walker ML, Kestle JR. Complications of intracranial pressure monitoring in children with head trauma. J Neurosurg. 2004 Aug;101(1 Suppl):53-8. doi: 10.3171/ped.2004.101.2.0053.
citation: Schmidt EA, Czosnyka M, Gooskens I, Piechnik SK, Matta BF, Whitfield PC, Pickard JD. Preliminary experience of the estimation of cerebral perfusion pressure using transcranial Doppler ultrasonography. J Neurol Neurosurg Psychiatry. 2001 Feb;70(2):198-204. doi: 10.1136/jnnp.70.2.198.
citation: Malayeri AA, Bavarian S, Mehdizadeh M. Sonographic evaluation of optic nerve diameter in children with raised intracranial pressure. J Ultrasound Med. 2005 Feb;24(2):143-7. doi: 10.7863/jum.2005.24.2.143.
citation: O'Brien NF, Reuter-Rice K, Wainwright MS, Kaplan SL, Appavu B, Erklauer JC, Ghosh S, Kirschen M, Kozak B, Lidsky K, Lovett ME, Mehollin-Ray AR, Miles DK, Press CA, Simon DW, Tasker RC, LaRovere KL. Practice Recommendations for Transcranial Doppler Ultrasonography in Critically Ill Children in the Pediatric Intensive Care Unit: A Multidisciplinary Expert Consensus Statement. J Pediatr Intensive Care. 2021 Jun;10(2):133-142. doi: 10.1055/s-0040-1715128. Epub 2020 Sep 4.