Intracranial HypertensionnICPpedNCT05340062
Non Invasive Measurement With Trans Cranial Doppler Versus Invasive Measurement in Pediatric Age
An observational study of Intracranial Hypertension, run by Azienda Ospedaliera di Padova at 6 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Intracranial Hypertension
- What is being tested?
- bedside sonography
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- 6 sitesItaly
- Study dates
- 1 Jul 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Child, Adult
Study population: pediatric patients with planned invasive ICP admitted to PICU
Who may be able to join
- invasive ICP placement
Who cannot join
- cranial base fracture
- absent informed consent
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Italy6 sites, 6 recruiting
- Not yet recruiting
PICU IRCSS Sant'Orsola Malpighi
Bologna
matilde santià
fabio caramelli
- Not yet recruiting
PICU Spedali Civili BRescia
Brescia
diego franchini
- Not yet recruiting
PICU Ospedale Mayer
Florence
francesca melosi
denise colosimo
- Not yet recruiting
PICU Ospedale Gaslini
Genova
stefano pezzato
marta fedriga
- Recruiting
PICU University Hospital Padova
Padova, 35128
angela amigoni, angela.amigoni@aopd.veneto.it
elisa poletto
- Not yet recruiting
PICU Università Cattolica
Roma
aldo mancino
About this study
Official title: The Accuracy of Intracranial Pressure Non Invasive Measurement With Trans Cranial Doppler Versus Invasive Measurement in Pediatric Age
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.
Read the 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.
- Conditions
- Intracranial Hypertension
- Being tested
- bedside sonography
- Keywords
- intracranial hypertension, children, cerebral perfusion
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bedside sonographyDevice
TCD and ONSD sonography twice a day per 2 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: bedside sonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: within 48 hours after the invasive ICP placement
Secondary outcomes (3)
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.
Measured: within 48 hours after the invasive ICP placement
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.
Measured: within 48 hours after the invasive ICP placement
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.
Measured: within 48 hours after the invasive ICP placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start1 Jul 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intracranial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, angela amigoni, Azienda Ospedaliera di Padova
- Investigators
- angela amigoni, MD, Principal investigator, University Hospital of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340062
- Sponsor's protocol ID
- 5210/AO/21
- Acronym
- nICPped
- Status last verified
- Jan 2025
- First submitted
- 31 Mar 2022
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 15145991Kochanek 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.
PubMed 30822776Anderson 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.
PubMed 16206972Schmidt 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.
PubMed 11160468Malayeri 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.
PubMed 15661943O'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.
PubMed 33884214
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Intracranial Pressure Non Invasive Measurement With Trans Cranial Doppler Versus Invasive Measurement in Pediatric Age
- ClinicalTrials.gov ID
- NCT05340062
- Acronym / sponsor ID
- nICPped / 5210/AO/21
- Conditions
- Intracranial Hypertension
- Keywords
- intracranial hypertension, children, cerebral perfusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di PadovaUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric patients with ICP device | – | Device: bedside sonographyIn 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 |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- pediatric patients with planned invasive ICP admitted to PICU
Key inclusion criteria (1 listed)
- invasive ICP placement
Key exclusion criteria (2 listed)
- cranial base fracture
- absent informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bedside sonographyTCD and ONSD sonography twice a day per 2 days | Device | pediatric patients with ICP device |
Primary outcome
comparison between ICP and nICP (measured by TCD)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
3 secondary outcomes
comparison between ICP and nICP (measured by ONSD)
Time frame: within 48 hours after the invasive ICP placement
interrater reliability for TCD measurement
Time frame: within 48 hours after the invasive ICP placement
interrater reliability for ONSD measurement
Time frame: within 48 hours after the invasive ICP placement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Results publication: PubMed 15145991Czosnyka 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.
- Results publication: PubMed 30822776Kochanek 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.
- Results publication: PubMed 16206972Anderson 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.
- Results publication: PubMed 11160468Schmidt 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.
- Results publication: PubMed 15661943Malayeri 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.
- Results publication: PubMed 33884214O'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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
angela amigoni, MD principal investigator
University Hospital of Padova
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Hypertension, run by Azienda Ospedaliera di Padova at 6 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact angela amigoni, MD (+39 339 8333765, angela.amigoni@aopd.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison between ICP and nICP (measured by TCD) (time frame: within 48 hours after the invasive ICP placement). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05340062, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.