Intracranial Pressure IncreaseDUAL-ICPNCT05346471
Infra- and Supratentorial Neuromonitoring
A study testing Multimodal neuromonitoring in people with Intracranial Pressure Increase and Posterior Fossa Lesion, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
Invasive neuromonitoring of intracranial pressure (ICP) is an important element of neurosurgical critical care that is used primarily as an indicator of adequate cerebral perfusion in patients, when clinical observation is not an option. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Pressure Increase, Posterior Fossa Lesion, Posterior Fossa Hemorrhage
- What is being tested?
- Multimodal neuromonitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 3 Jun 2019to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Posterior fossa lesions with anticipated prolonged neurointensive critical care
- Patients older than 18 years
- Informed consent if applicable (unconscious patients will be also enrolled)
- No existing exclusion criteria
Who cannot join
- Coagulation disorders
- Age < 18 years
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Thomas Petutschnigg contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Innsbruck
Innsbruck, Tyrol, 6020
About this study
Official title: Infra- and Supratentorial Neuromonitoring in Patients With Posterior Fossa Lesions: DUAL-ICP Trial
Invasive neuromonitoring of intracranial pressure (ICP) is an important element of neurosurgical critical care that is used primarily as an indicator of adequate cerebral perfusion in patients, when clinical observation is not an option. Due to the constraint in size and the critical structures within the posterior fossa, detection of intracranial pressure particularly in the postoperative phase has been deemed desirable in patients with surgery in this region, particularly in those subjected to prolonged procedures and critical care.
The posterior fossa is an anatomically constricted compartment with narrow spaces and intracranial hypertension quickly leads to brainstem damage and neurological dysfunction. ICP in the supratentorial space not necessarily correlates with ICP in the infratentorial space. Some authors claim that it would be beneficial to measure ICP in infratentorial space after posterior fossa surgery in some cases.
Read more
The relationship between the intracranial pressure profiles in the supratentorial and infratentorial compartments remain unclear. After a neurosurgical operation in the posterior fossa there are most likely pressure differences between supra- and infratentorial spaces. It is well known that the pressure within the skull is unevenly distributed, with appreciable ICP gradients.
Thus, the investigators intend to apply the intracranial multimodal monitoring in both infratentorial and supratentorial compartments simultaneously. Such coincident measurements most likely will be the most sensitive way to assess focal swelling, ischemia and tissue perfusion, or other relevant complications in the posterior fossa structures.
The goal of this study is to test whether direct infratentorial monitoring is a more efficacious method for detecting dynamic changes in the operative compartment and whether it is safe, in view of the critical structures within the region.
Read the detailed description
Invasive neuromonitoring of intracranial pressure (ICP) is an important element of neurosurgical critical care that is used primarily as an indicator of adequate cerebral perfusion in patients, when clinical observation is not an option. Due to the constraint in size and the critical structures within the posterior fossa, continuous detection of postoperative pressures has been deemed desirable in patients with surgery in this region, particularly in those subjected to prolonged procedures and critical care.
The posterior fossa is an anatomically constricted compartment with narrow spaces and intracranial hypertension quickly leads to brainstem damage and neurological dysfunction. ICP in the supratentorial space not necessarily correlates with ICP in the infratentorial space. Some authors claim that it would be beneficial to measure ICP in infratentorial space after posterior fossa surgery in some cases.
In patients whose neurological examination results may be inconclusive or limited, it is valuable to have a reliable alternative method of evaluation. It is generally accepted that continuous ICP monitoring is very important to determine the timing of surgery and to prevent secondary brain damage caused by increased ICP.
There have been few clinical studies in which simultaneous pressures were recorded above and below the tentorium in patients with intracranial pathology. Yet, the relevance of infratentorial neuromonitoring remains largely unclear. So far, the placement of ICP probes in the posterior fossa seems to carry very low morbidity. Furthermore, to rely on autonomic changes, neurological deterioration, or measurements of only the supratentorial compartment as a sign of relevant complications in the posterior fossa highly narrows the temporal margin of safety for the institution of treatment. Comprehensive evaluation of possible risks of posterior fossa lesions and their treatments is crucial. Of note, immediate detection of treatment-related complications is often challenging, still being able to avoid permanent neurological sequelae. The application of the advanced neuromonitoring in the posterior fossa may be supportive in achieving this difficult goal and may provide objective assessments of procedure-related complications.
Therefore, the data generated by our prospective trial can be expected to be beneficial in individualized treatment plans. It is a relatively novel approach to intracranial multimodal neuromonitoring. The application of infratentorial probes offers potential for better understanding of lesion maturation and progression, clinical deterioration, and monitoring the effect of treatments.
The investigators hypothesize that additional multimodal infratentorial neuromonitoring will be of high clinical value detecting any relevant complication and giving detailed insight in pathophysiological interactions in posterior fossa lesions.
- Being tested
- Multimodal neuromonitoring
- Keywords
- Infratentorial Neuromonitoring
- Medical subject headings
- Intracranial Hypertension, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal neuromonitoringDevice
Multimodal neuromonitoring accounts for intraparenchymatous ICP probe, brain tissue oxygen probe and/or cerebral microdialysis device
| Study group | Role | What they receive |
|---|---|---|
| Acute posterior fossa lesions | Other | Subjects will receive additional multimodal infratentorial neuromonitoring Receives: Device: Multimodal neuromonitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of device-related events [Safety and Tolerability]
All device-related events (infections, tissue irritation, haemorrhage along device trajectory, dural leaks etc.) will be noted and reported, even if no clinical consequence will ensue
Measured: From implementation until removing of infratentorial multimodal neuromonitoring, assessed up to 30 days
Correlation
Correlation analysis of supra- and infratentorial measures
Measured: As long as neuromonitoring is indicated, assessed up to 30 days
Glasgow Outcome Scale (GOS) after 3 months
GOS to asses the potential influence of infratentorial monitoring measures on clinical outcome (GOS 1-3 poor outcome; GOS 4-5 good outcome)
Measured: Assessed 3 months after initial treatment
Glasgow Outcome Scale (GOS) after 6 months
GOS to asses the potential influence of infratentorial monitoring measures on clinical outcome (GOS 1-3 poor outcome; GOS 4-5 good outcome)
Measured: Assessed 6 months after initial treatment
Glasgow Outcome Scale (GOS) after 9 months
GOS to asses the potential influence of infratentorial monitoring measures on clinical outcome (GOS 1-3 poor outcome; GOS 4-5 good outcome)
Measured: Assessed 9 months after initial treatment
modified Ranking Scale (mRS) after 3 months
mRS as alternative outcome measure to asses the potential influence of infratentorial monitoring measures on clinical outcome (mRS 0-6; the higher the worse the outcome)
Measured: Assessed 3 months after initial treatment
modified Ranking Scale (mRS) after 6 months
mRS as alternative outcome measure to asses the potential influence of infratentorial monitoring measures on clinical outcome (mRS 0-6; the higher the worse the outcome)
Measured: Assessed 6 months after initial treatment
modified Ranking Scale (mRS) after 9 months
mRS as alternative outcome measure to asses the potential influence of infratentorial monitoring measures on clinical outcome (mRS 0-6; the higher the worse the outcome)
Measured: Assessed 9 months after initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start3 Jun 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Intracranial Pressure IncreaseStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ondra Petr, MD PhD, Principal investigator, Consultant - Faculty/Staff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346471
- Sponsor's protocol ID
- NCH -11112018
- Acronym
- DUAL-ICP
- Status last verified
- Jan 2022
- First submitted
- 30 Mar 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Collection of data and publish results
Publications
Slavin KV, Misra M. Infratentorial intracranial pressure monitoring in neurosurgical intensive care unit. Neurol Res. 2003 Dec;25(8):880-4. doi: 10.1179/016164103771954014.
PubMed 14669535Khan A, Borg N, Shenouda E. Posterior fossa ICP monitoring: a tale of two compartments. Br J Neurosurg. 2021 Apr;35(2):129-132. doi: 10.1080/02688697.2020.1765974. Epub 2020 May 15.
PubMed 32410470Rosenwasser RH, Kleiner LI, Krzeminski JP, Buchheit WA. Intracranial pressure monitoring in the posterior fossa: a preliminary report. J Neurosurg. 1989 Oct;71(4):503-5. doi: 10.3171/jns.1989.71.4.0503.
PubMed 2795169Moyse E, Ros M, Marhar F, Swider P, Schmidt EA. Characterisation of Supra- and Infratentorial ICP Profiles. Acta Neurochir Suppl. 2016;122:37-40. doi: 10.1007/978-3-319-22533-3_7.
PubMed 27165873LANGFITT TW, WEINSTEIN JD, KASSELL NF, SIMEONE FA. TRANSMISSION OF INCREASED INTRACRANIAL PRESSURE. I. WITHIN THE CRANIOSPINAL AXIS. J Neurosurg. 1964 Nov;21:989-97. doi: 10.3171/jns.1964.21.11.0989. No abstract available.
PubMed 14238966Wolfla CE, Luerssen TG, Bowman RM, Putty TK. Brain tissue pressure gradients created by expanding frontal epidural mass lesion. J Neurosurg. 1996 Apr;84(4):642-7. doi: 10.3171/jns.1996.84.4.0642.
PubMed 8613857Vanaclocha V, Saiz-Sapena N, Rivera-Paz M, Herrera JM, Ortiz-Criado JM, Verdu-Lopez F, Vanaclocha L. Can we safely monitor posterior fossa intracranial pressure? A cadaveric study. Br J Neurosurg. 2017 Oct;31(5):557-563. doi: 10.1080/02688697.2017.1332336. Epub 2017 May 25.
PubMed 28539078Rosner MJ, Becker DP. ICP monitoring: complications and associated factors. Clin Neurosurg. 1976;23:494-519. doi: 10.1093/neurosurgery/23.cn_suppl_1.494.
PubMed 975699Maas AI, Schouten JW, Stocchetti N, Bullock R, Ghajar J. Questioning the value of intracranial pressure (ICP) monitoring in patients with brain injuries. J Trauma. 2008 Oct;65(4):966-7. doi: 10.1097/TA.0b013e318184ee7b. No abstract available.
PubMed 18849824Saul TG, Ducker TB. Effect of intracranial pressure monitoring and aggressive treatment on mortality in severe head injury. J Neurosurg. 1982 Apr;56(4):498-503. doi: 10.3171/jns.1982.56.4.0498.
PubMed 6801218Piek J, Bock WJ. Continuous monitoring of cerebral tissue pressure in neurosurgical practice--experiences with 100 patients. Intensive Care Med. 1990;16(3):184-8. doi: 10.1007/BF01724800.
PubMed 2351779Petr O, Ho WM, Petutschnigg T, Krigers A, Treichl SA, Preuss-Hernandez C, Brawanski K, Helbok R, Thome C. Link between both infratentorial and supratentorial intracranial pressure burdens and final outcome in patients with infratentorial brain injury. J Neurosurg. 2023 Apr 28;139(5):1430-1438. doi: 10.3171/2023.1.JNS221806. Print 2023 Nov 1.
PubMed 37119097
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infra- and Supratentorial Neuromonitoring in Patients With Posterior Fossa Lesions: DUAL-ICP Trial
- ClinicalTrials.gov ID
- NCT05346471
- Acronym / sponsor ID
- DUAL-ICP / NCH -11112018
- Keywords
- Infratentorial Neuromonitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 26 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.
Invasive neuromonitoring of intracranial pressure (ICP) is an important element of neurosurgical critical care that is used primarily as an indicator of adequate cerebral perfusion in patients, when clinical observation is not an option. Due to the constraint in size and the critical structures within the posterior fossa, detection of intracranial pressure particularly in the postoperative phase has been deemed desirable in patients with surgery in this region, particularly in those subjected to prolonged procedures and critical care.
The posterior fossa is an anatomically constricted compartment with narrow spaces and intracranial hypertension quickly leads to brainstem damage and neurological dysfunction. ICP in the supratentorial space not necessarily correlates with ICP in the infratentorial space. Some authors claim that it would be beneficial to measure ICP in infratentorial space after posterior fossa surgery in some cases.
The relationship between the intracranial pressure profiles in the supratentorial and infratentorial compartments remain unclear. After a neurosurgical operation in the posterior fossa there are most likely pressure differences between supra- and infratentorial spaces. It is well known that the pressure within the skull is unevenly distributed, with appreciable ICP gradients.
Thus, the investigators intend to apply the intracranial multimodal monitoring in both infratentorial and supratentorial compartments simultaneously. Such coincident measurements most likely will be the most sensitive way to assess focal swelling, ischemia and tissue perfusion, or other relevant complications in the posterior fossa structures.
The goal of this study is to test whether direct infratentorial monitoring is a more efficacious method for detecting dynamic changes in the operative compartment and whether it is safe, in view of the critical structures within the region.
Detailed description
Invasive neuromonitoring of intracranial pressure (ICP) is an important element of neurosurgical critical care that is used primarily as an indicator of adequate cerebral perfusion in patients, when clinical observation is not an option. Due to the constraint in size and the critical structures within the posterior fossa, continuous detection of postoperative pressures has been deemed desirable in patients with surgery in this region, particularly in those subjected to prolonged procedures and critical care.
The posterior fossa is an anatomically constricted compartment with narrow spaces and intracranial hypertension quickly leads to brainstem damage and neurological dysfunction. ICP in the supratentorial space not necessarily correlates with ICP in the infratentorial space. Some authors claim that it would be beneficial to measure ICP in infratentorial space after posterior fossa surgery in some cases.
In patients whose neurological examination results may be inconclusive or limited, it is valuable to have a reliable alternative method of evaluation. It is generally accepted that continuous ICP monitoring is very important to determine the timing of surgery and to prevent secondary brain damage caused by increased ICP.
There have been few clinical studies in which simultaneous pressures were recorded above and below the tentorium in patients with intracranial pathology. Yet, the relevance of infratentorial neuromonitoring remains largely unclear. So far, the placement of ICP probes in the posterior fossa seems to carry very low morbidity. Furthermore, to rely on autonomic changes, neurological deterioration, or measurements of only the supratentorial compartment as a sign of relevant complications in the posterior fossa highly narrows the temporal margin of safety for the institution of treatment. Comprehensive evaluation of possible risks of posterior fossa lesions and their treatments is crucial. Of note, immediate detection of treatment-related complications is often challenging, still being able to avoid permanent neurological sequelae. The application of the advanced neuromonitoring in the posterior fossa may be supportive in achieving this difficult goal and may provide objective assessments of procedure-related complications.
Therefore, the data generated by our prospective trial can be expected to be beneficial in individualized treatment plans. It is a relatively novel approach to intracranial multimodal neuromonitoring. The application of infratentorial probes offers potential for better understanding of lesion maturation and progression, clinical deterioration, and monitoring the effect of treatments.
The investigators hypothesize that additional multimodal infratentorial neuromonitoring will be of high clinical value detecting any relevant complication and giving detailed insight in pathophysiological interactions in posterior fossa lesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute posterior fossa lesions | Other | Device: Multimodal neuromonitoringSubjects will receive additional multimodal infratentorial neuromonitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Posterior fossa lesions with anticipated prolonged neurointensive critical care
- Patients older than 18 years
- Informed consent if applicable (unconscious patients will be also enrolled)
- No existing exclusion criteria
Key exclusion criteria (3 listed)
- Coagulation disorders
- Age < 18 years
- Pregnancy
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 |
|---|---|---|
| Multimodal neuromonitoringMultimodal neuromonitoring accounts for intraparenchymatous ICP probe, brain tissue oxygen probe and/or cerebral microdialysis device | Device | Acute posterior fossa lesions |
Primary outcome
Incidence of device-related events [Safety and Tolerability]
Time frame: From implementation until removing of infratentorial multimodal neuromonitoring, assessed up to 30 days
All device-related events (infections, tissue irritation, haemorrhage along device trajectory, dural leaks etc.) will be noted and reported, even if no clinical consequence will ensue
Correlation
Time frame: As long as neuromonitoring is indicated, assessed up to 30 days
Correlation analysis of supra- and infratentorial measures
Glasgow Outcome Scale (GOS) after 3 months
Time frame: Assessed 3 months after initial treatment
GOS to asses the potential influence of infratentorial monitoring measures on clinical outcome (GOS 1-3 poor outcome; GOS 4-5 good outcome)
Glasgow Outcome Scale (GOS) after 6 months
Time frame: Assessed 6 months after initial treatment
GOS to asses the potential influence of infratentorial monitoring measures on clinical outcome (GOS 1-3 poor outcome; GOS 4-5 good outcome)
Glasgow Outcome Scale (GOS) after 9 months
Time frame: Assessed 9 months after initial treatment
GOS to asses the potential influence of infratentorial monitoring measures on clinical outcome (GOS 1-3 poor outcome; GOS 4-5 good outcome)
modified Ranking Scale (mRS) after 3 months
Time frame: Assessed 3 months after initial treatment
mRS as alternative outcome measure to asses the potential influence of infratentorial monitoring measures on clinical outcome (mRS 0-6; the higher the worse the outcome)
modified Ranking Scale (mRS) after 6 months
Time frame: Assessed 6 months after initial treatment
mRS as alternative outcome measure to asses the potential influence of infratentorial monitoring measures on clinical outcome (mRS 0-6; the higher the worse the outcome)
modified Ranking Scale (mRS) after 9 months
Time frame: Assessed 9 months after initial treatment
mRS as alternative outcome measure to asses the potential influence of infratentorial monitoring measures on clinical outcome (mRS 0-6; the higher the worse the outcome)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Background: PubMed 14669535Slavin KV, Misra M. Infratentorial intracranial pressure monitoring in neurosurgical intensive care unit. Neurol Res. 2003 Dec;25(8):880-4. doi: 10.1179/016164103771954014.
- Background: PubMed 32410470Khan A, Borg N, Shenouda E. Posterior fossa ICP monitoring: a tale of two compartments. Br J Neurosurg. 2021 Apr;35(2):129-132. doi: 10.1080/02688697.2020.1765974. Epub 2020 May 15.
- Background: PubMed 2795169Rosenwasser RH, Kleiner LI, Krzeminski JP, Buchheit WA. Intracranial pressure monitoring in the posterior fossa: a preliminary report. J Neurosurg. 1989 Oct;71(4):503-5. doi: 10.3171/jns.1989.71.4.0503.
- Background: PubMed 27165873Moyse E, Ros M, Marhar F, Swider P, Schmidt EA. Characterisation of Supra- and Infratentorial ICP Profiles. Acta Neurochir Suppl. 2016;122:37-40. doi: 10.1007/978-3-319-22533-3_7.
- Background: PubMed 14238966LANGFITT TW, WEINSTEIN JD, KASSELL NF, SIMEONE FA. TRANSMISSION OF INCREASED INTRACRANIAL PRESSURE. I. WITHIN THE CRANIOSPINAL AXIS. J Neurosurg. 1964 Nov;21:989-97. doi: 10.3171/jns.1964.21.11.0989. No abstract available.
- Background: PubMed 8613857Wolfla CE, Luerssen TG, Bowman RM, Putty TK. Brain tissue pressure gradients created by expanding frontal epidural mass lesion. J Neurosurg. 1996 Apr;84(4):642-7. doi: 10.3171/jns.1996.84.4.0642.
- Background: PubMed 28539078Vanaclocha V, Saiz-Sapena N, Rivera-Paz M, Herrera JM, Ortiz-Criado JM, Verdu-Lopez F, Vanaclocha L. Can we safely monitor posterior fossa intracranial pressure? A cadaveric study. Br J Neurosurg. 2017 Oct;31(5):557-563. doi: 10.1080/02688697.2017.1332336. Epub 2017 May 25.
- Background: PubMed 975699Rosner MJ, Becker DP. ICP monitoring: complications and associated factors. Clin Neurosurg. 1976;23:494-519. doi: 10.1093/neurosurgery/23.cn_suppl_1.494.
- Background: PubMed 18849824Maas AI, Schouten JW, Stocchetti N, Bullock R, Ghajar J. Questioning the value of intracranial pressure (ICP) monitoring in patients with brain injuries. J Trauma. 2008 Oct;65(4):966-7. doi: 10.1097/TA.0b013e318184ee7b. No abstract available.
- Background: PubMed 6801218Saul TG, Ducker TB. Effect of intracranial pressure monitoring and aggressive treatment on mortality in severe head injury. J Neurosurg. 1982 Apr;56(4):498-503. doi: 10.3171/jns.1982.56.4.0498.
- Background: PubMed 2351779Piek J, Bock WJ. Continuous monitoring of cerebral tissue pressure in neurosurgical practice--experiences with 100 patients. Intensive Care Med. 1990;16(3):184-8. doi: 10.1007/BF01724800.
- Derived from this study: PubMed 37119097Petr O, Ho WM, Petutschnigg T, Krigers A, Treichl SA, Preuss-Hernandez C, Brawanski K, Helbok R, Thome C. Link between both infratentorial and supratentorial intracranial pressure burdens and final outcome in patients with infratentorial brain injury. J Neurosurg. 2023 Apr 28;139(5):1430-1438. doi: 10.3171/2023.1.JNS221806. Print 2023 Nov 1.
- Individual participant dataSharing planned: No. Collection of data and publish results
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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. This study is not recruiting at the moment.
Thomas Petutschnigg contact
Ondra Petr, MD PhD principal investigator
Consultant - Faculty/Staff
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal neuromonitoring in people with Intracranial Pressure Increase and Posterior Fossa Lesion, run by Medical University Innsbruck at 1 site in Austria.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ondra Petr, MD PhD (+43 512 504 ext. 81286, ondra.petr@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of device-related events [Safety and Tolerability] (time frame: From implementation until removing of infratentorial multimodal neuromonitoring, assessed up to 30 days). The study lists 8 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 NCT05346471, which also lists 12 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 26 Apr 2022; AzTrials last refreshed its copy on 2 Nov 2026.