Non Invasive Measurement With Trans Cranial Doppler Versus Invasive Measurement in Pediatric Age

Intracranial Hypertension Clinical Trial

— nICPped  

Official title:

The Accuracy of Intracranial Pressure Non Invasive Measurement With Trans Cranial Doppler Versus Invasive Measurement in Pediatric Age

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05340062
• Other study ID #: 5210/AO/21
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Azienda Ospedaliera di Padova
• Contact: angela amigoni, MD
• Phone: +39 339 8333765
• Email: angela.amigoni[@]aopd.veneto.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• invasive ICP placement

Exclusion Criteria:

• cranial base fracture
• absent informed consent

Related Conditions & MeSH terms

• Hypertension
• Intracranial Hypertension

Intervention

Device:
• bedside sonography
TCD and ONSD sonography twice a day per 2 days

Locations

Country	Name	City	State
Italy	PICU IRCSS Sant'Orsola Malpighi	Bologna
Italy	PICU Spedali Civili BRescia	Brescia
Italy	PICU Ospedale Mayer	Firenze
Italy	PICU Ospedale Gaslini	Genova
Italy	PICU University Hospital Padova	Padova
Italy	PICU Università Cattolica	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera di Padova

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View 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. — View 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, — View 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. — View 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 Ultraso — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	within 48 hours after the invasive ICP placement
Primary	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).	within 48 hours after the invasive ICP placement
Primary	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).	within 48 hours after the invasive ICP placement
Primary	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).	within 48 hours after the invasive ICP placement
Secondary	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.	within 48 hours after the invasive ICP placement
Secondary	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.	within 48 hours after the invasive ICP placement
Secondary	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.	within 48 hours after the invasive ICP placement