Studies
| Study First Submitted Date | 2022-03-30 |
| Study First Posted Date | 2022-04-26 |
| Last Update Posted Date | 2022-04-26 |
| Start Month Year | June 3, 2019 |
| Primary Completion Month Year | December 31, 2024 |
| Verification Month Year | January 2022 |
| Verification Date | 2022-01-31 |
| Last Update Posted Date | 2022-04-26 |
Detailed Descriptions
| Sequence: | 20827556 |
| 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. |
Facilities
| Sequence: | 201088812 |
| Status | Recruiting |
| Name | Medical University of Innsbruck |
| City | Innsbruck |
| State | Tirol |
| Zip | 6020 |
| Country | Austria |
Conditions
| Sequence: | 52443346 | Sequence: | 52443347 | Sequence: | 52443348 |
| Name | Intracranial Pressure Increase | Name | Posterior Fossa Lesion | Name | Posterior Fossa Hemorrhage |
| Downcase Name | intracranial pressure increase | Downcase Name | posterior fossa lesion | Downcase Name | posterior fossa hemorrhage |
Id Information
| Sequence: | 40353211 |
| Id Source | org_study_id |
| Id Value | NCH -11112018 |
Countries
| Sequence: | 42786985 |
| Name | Austria |
| Removed | False |
Design Groups
| Sequence: | 55895480 |
| Group Type | Other |
| Title | Acute posterior fossa lesions |
| Description | Subjects will receive additional multimodal infratentorial neuromonitoring |
Interventions
| Sequence: | 52753362 |
| Intervention Type | Device |
| Name | Multimodal neuromonitoring |
| Description | Multimodal neuromonitoring accounts for intraparenchymatous ICP probe, brain tissue oxygen probe and/or cerebral microdialysis device |
Keywords
| Sequence: | 80237920 |
| Name | Infratentorial Neuromonitoring |
| Downcase Name | infratentorial neuromonitoring |
Design Outcomes
| Sequence: | 178403210 | Sequence: | 178403211 | Sequence: | 178403212 | Sequence: | 178403213 | Sequence: | 178403214 | Sequence: | 178403215 | Sequence: | 178403216 | Sequence: | 178403217 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
| Measure | Incidence of device-related events [Safety and Tolerability] | Measure | Correlation | Measure | Glasgow Outcome Scale (GOS) after 3 months | Measure | Glasgow Outcome Scale (GOS) after 6 months | Measure | Glasgow Outcome Scale (GOS) after 9 months | Measure | modified Ranking Scale (mRS) after 3 months | Measure | modified Ranking Scale (mRS) after 6 months | Measure | modified Ranking Scale (mRS) after 9 months |
| Time Frame | From implementation until removing of infratentorial multimodal neuromonitoring, assessed up to 30 days | Time Frame | As long as neuromonitoring is indicated, assessed up to 30 days | Time Frame | Assessed 3 months after initial treatment | Time Frame | Assessed 6 months after initial treatment | Time Frame | Assessed 9 months after initial treatment | Time Frame | Assessed 3 months after initial treatment | Time Frame | Assessed 6 months after initial treatment | Time Frame | Assessed 9 months after initial treatment |
| Description | 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 | Description | Correlation analysis of supra- and infratentorial measures | Description | GOS to asses the potential influence of infratentorial monitoring measures on clinical outcome (GOS 1-3 poor outcome; GOS 4-5 good outcome) | Description | GOS to asses the potential influence of infratentorial monitoring measures on clinical outcome (GOS 1-3 poor outcome; GOS 4-5 good outcome) | Description | GOS to asses the potential influence of infratentorial monitoring measures on clinical outcome (GOS 1-3 poor outcome; GOS 4-5 good outcome) | Description | 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) | Description | 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) | Description | 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) |
Browse Conditions
| Sequence: | 194525617 | Sequence: | 194525618 | Sequence: | 194525619 | Sequence: | 194525620 | Sequence: | 194525621 | Sequence: | 194525622 | Sequence: | 194525623 | Sequence: | 194525624 | Sequence: | 194525625 | Sequence: | 194525626 |
| Mesh Term | Intracranial Hypertension | Mesh Term | Intracranial Hemorrhages | Mesh Term | Hemorrhage | Mesh Term | Pathologic Processes | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Cerebrovascular Disorders | Mesh Term | Vascular Diseases | Mesh Term | Cardiovascular Diseases |
| Downcase Mesh Term | intracranial hypertension | Downcase Mesh Term | intracranial hemorrhages | Downcase Mesh Term | hemorrhage | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | cerebrovascular disorders | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | cardiovascular diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48571615 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Medical University Innsbruck |
Overall Officials
| Sequence: | 29427367 |
| Role | Principal Investigator |
| Name | Ondra Petr, MD PhD |
| Affiliation | Consultant – Faculty/Staff |
Central Contacts
| Sequence: | 12079563 | Sequence: | 12079564 |
| Contact Type | primary | Contact Type | backup |
| Name | Ondra Petr, MD PhD | Name | Thomas Petutschnigg |
| Phone | +43 512 504 | ||
| [email protected] | [email protected] | ||
| Phone Extension | 81286 | ||
| Role | Contact | Role | Contact |
Design Group Interventions
| Sequence: | 68522134 |
| Design Group Id | 55895480 |
| Intervention Id | 52753362 |
Eligibilities
| Sequence: | 30921432 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| Criteria | Inclusion Criteria: 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 Exclusion Criteria: Coagulation disorders Age < 18 years Pregnancy |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254190987 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2022 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | True |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 8 |
Designs
| Sequence: | 30667100 |
| Allocation | N/A |
| Intervention Model | Single Group Assignment |
| Observational Model | |
| Primary Purpose | Diagnostic |
| Time Perspective | |
| Masking | None (Open Label) |
Provided Documents
| Sequence: | 2599416 |
| Document Type | Study Protocol and Statistical Analysis Plan |
| Has Protocol | True |
| Has Icf | False |
| Has Sap | True |
| Document Date | 2019-04-04 |
| Url | https://ClinicalTrials.gov/ProvidedDocs/71/NCT05346471/Prot_SAP_000.pdf |
Responsible Parties
| Sequence: | 29033800 |
| Responsible Party Type | Sponsor |
Study References
| Sequence: | 52351693 | Sequence: | 52351694 | Sequence: | 52351695 | Sequence: | 52351696 | Sequence: | 52351697 | Sequence: | 52351698 | Sequence: | 52351699 | Sequence: | 52351700 | Sequence: | 52351701 | Sequence: | 52351702 | Sequence: | 52351703 |
| Pmid | 14669535 | Pmid | 32410470 | Pmid | 2795169 | Pmid | 27165873 | Pmid | 14238966 | Pmid | 8613857 | Pmid | 28539078 | Pmid | 975699 | Pmid | 18849824 | Pmid | 6801218 | Pmid | 2351779 |
| Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
| Citation | 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. | Citation | Khan 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. | Citation | Rosenwasser 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. | Citation | Moyse 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. | Citation | LANGFITT 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. | Citation | Wolfla 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. | Citation | Vanaclocha 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. | Citation | Rosner MJ, Becker DP. ICP monitoring: complications and associated factors. Clin Neurosurg. 1976;23:494-519. doi: 10.1093/neurosurgery/23.cn_suppl_1.494. | Citation | Maas 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. | Citation | Saul 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. | Citation | Piek 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. |