Infra- and Supratentorial Neuromonitoring

NCT05346471 | Unknown

• 1 other identifier: NCH -11112018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Intracranial Pressure Increase; Posterior Fossa Lesion; Posterior Fossa Hemorrhage

Keywords

Infratentorial Neuromonitoring

Outcome Measures

Primary Outcomes (8)

• 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

  From implementation until removing of infratentorial multimodal neuromonitoring, assessed up to 30 days

• Correlation

  Correlation analysis of supra- and infratentorial measures

  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)

  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)

  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)

  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)

  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)

  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)

  Assessed 9 months after initial treatment

Study Arms (1)

Acute posterior fossa lesions

OTHER

Subjects will receive additional multimodal infratentorial neuromonitoring

Device: Multimodal neuromonitoring

Interventions

Multimodal neuromonitoring DEVICE

Multimodal neuromonitoring accounts for intraparenchymatous ICP probe, brain tissue oxygen probe and/or cerebral microdialysis device

Acute posterior fossa lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Posterior fossa lesions with anticipated prolonged neurointensive critical care
• Patients older than 18 years
• Informed consent if applicable (unconscious patients will be also enrolled)

You may not qualify if:

• Coagulation disorders
• Age \< 18 years
• Pregnancy

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Related Publications (12)

• 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.

  PMID: 14669535 BACKGROUND

• 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.

  PMID: 32410470 BACKGROUND

• 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.

  PMID: 2795169 BACKGROUND

• 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.

  PMID: 27165873 BACKGROUND

• 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.

  PMID: 14238966 BACKGROUND

• 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.

  PMID: 8613857 BACKGROUND

• 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.

  PMID: 28539078 BACKGROUND

• 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.

  PMID: 975699 BACKGROUND

• 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.

  PMID: 18849824 BACKGROUND

• 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.

  PMID: 6801218 BACKGROUND

• 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.

  PMID: 2351779 BACKGROUND

• Petr 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.

  PMID: 37119097 DERIVED

MeSH Terms

Conditions

Intracranial Hypertension; Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ondra Petr, MD PhD

  Consultant - Faculty/Staff

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ondra Petr, MD PhD

CONTACT

+43 512 504; ondra.petr@i-med.ac.at

Thomas Petutschnigg

CONTACT

thomas.petutschnigg@student.i-med.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 26, 2022
• Study Start: June 3, 2019
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: April 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)