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

NCT05340062 | Recruiting

• 1 other identifier: 5210/AO/21
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 6

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.

Conditions

Intracranial Hypertension

Keywords

intracranial hypertension; children; cerebral perfusion

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (3)

• comparison between ICP and nICP (measured by ONSD)

  within 48 hours after the invasive ICP placement

• interrater reliability for TCD measurement

  within 48 hours after the invasive ICP placement

• interrater reliability for ONSD measurement

  within 48 hours after the invasive ICP placement

Study Arms (1)

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

Interventions

bedside sonography DEVICE

TCD and ONSD sonography twice a day per 2 days

pediatric patients with ICP device

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

pediatric patients with planned invasive ICP admitted to PICU

You may qualify if:

• invasive ICP placement

You may not qualify if:

• cranial base fracture
• absent informed consent

Sponsors & Collaborators

• Azienda Ospedaliera di Padova: lead

Study Sites (6)

PICU IRCSS Sant'Orsola Malpighi

Bologna, Italy

NOT YET RECRUITING

PICU Spedali Civili BRescia

Brescia, Italy

NOT YET RECRUITING

PICU Ospedale Mayer

Florence, Italy

NOT YET RECRUITING

PICU Ospedale Gaslini

Genova, Italy

NOT YET RECRUITING

PICU University Hospital Padova

Padua, 35128, Italy

RECRUITING

PICU Università Cattolica

Roma, Italy

NOT YET RECRUITING

Related Publications (6)

• 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.

  PMID: 15145991 RESULT

• 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.

  PMID: 30822776 RESULT

• 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.

  PMID: 16206972 RESULT

• 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.

  PMID: 11160468 RESULT

• 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.

  PMID: 15661943 RESULT

• 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.

  PMID: 33884214 RESULT

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• angela amigoni, MD

  University Hospital of Padova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

angela amigoni, MD

CONTACT

+39 339 8333765; angela.amigoni@aopd.veneto.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 21, 2022
• Study Start: July 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

IT (6)