iNtrAcranial PreSsurE in Intensive Care (ICU) (SynapseICU)

NCT03257904 | Completed DMC

• 1 other identifier: SynapseICU
• Study Type: observational
• Target: 2,395
• Locations: 1 country
• Sites: 1

Brief Summary

Intracranial pressure (ICP) monitoring is the most common neuromonitoring modality used in neurocritical care units (NCCU) around the world. Uncertainties remain around intracranial pressure monitoring both in traumatic and non-traumatic brain injury, and variation in clinical practice of intracranial pressure monitoring exists between neurocritical care units. The objectives of the study will explore intracranial pressure monitoring variation in practice to prioritise uncertainties in the clinical management of critical care patients with acute brain injury and support further collaborative hypotheses-based prospective studies.

Conditions

Traumatic Brain Injury; Subarachnoid Hemorrhage; Intracerebral Hemorrhage

Keywords

intracranial pressure

Outcome Measures

Primary Outcomes (1)

• Long-term outcome measures of neurological disability

  Extended Glasgow Outcome Scale score

  6 months

Interventions

intracranial pressure monitoring PROCEDURE

measurement of intracranial pressure

Eligibility Criteria

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

Study Population

Hemorrhagic stroke, including intracerebral hematoma and subarachnoid hemorrhage, Traumatic brain injury

You may qualify if:

• Age \> 18 years;
• Diagnosis of an acute brain injury (ABI) due to primary hemorrhagic stroke (including intracranial hemorrhage or subarachnoid hemorrhage) or traumatic brain injury;
• Glasgow Coma Score with Eyes response = 1 (no eyes opening) and Motor score ≤5 (not following commands) at the admission to ICU or neuro-worsening within the first 48 hours with no eye opening and the Motor score decreased to ≤5.

You may not qualify if:

• Acute Brain Injury (ABI) who are not admitted to ICU;

Sponsors & Collaborators

• University of Milano Bicocca: lead
• European Society of Intensive Care Medicine: collaborator

Study Sites (1)

ASST-Monza

Monza, MB, 20900, Italy

Location

Related Publications (17)

• Stocchetti N, Carbonara M, Citerio G, Ercole A, Skrifvars MB, Smielewski P, Zoerle T, Menon DK. Severe traumatic brain injury: targeted management in the intensive care unit. Lancet Neurol. 2017 Jun;16(6):452-464. doi: 10.1016/S1474-4422(17)30118-7.

  PMID: 28504109 BACKGROUND

• Carney N, Totten AM, O'Reilly C, Ullman JS, Hawryluk GW, Bell MJ, Bratton SL, Chesnut R, Harris OA, Kissoon N, Rubiano AM, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition. Neurosurgery. 2017 Jan 1;80(1):6-15. doi: 10.1227/NEU.0000000000001432.

  PMID: 27654000 BACKGROUND

• Cnossen MC, Scholten AC, Lingsma HF, Synnot A, Tavender E, Gantner D, Lecky F, Steyerberg EW, Polinder S. Adherence to Guidelines in Adult Patients with Traumatic Brain Injury: A Living Systematic Review. J Neurotrauma. 2021 Apr 15;38(8):1072-1085. doi: 10.1089/neu.2015.4121. Epub 2016 Aug 25.

  PMID: 26431625 BACKGROUND

• Helbok R, Olson DM, Le Roux PD, Vespa P; Participants in the International Multidisciplinary Consensus Conference on Multimodality Monitoring. Intracranial pressure and cerebral perfusion pressure monitoring in non-TBI patients: special considerations. Neurocrit Care. 2014 Dec;21 Suppl 2:S85-94. doi: 10.1007/s12028-014-0040-6.

  PMID: 25208677 BACKGROUND

• Chesnut RM, Bleck TP, Citerio G, Classen J, Cooper DJ, Coplin WM, Diringer MN, Grande PO, Hemphill JC 3rd, Hutchinson PJ, Le Roux P, Mayer SA, Menon DK, Myburgh JA, Okonkwo DO, Robertson CS, Sahuquillo J, Stocchetti N, Sung G, Temkin N, Vespa PM, Videtta W, Yonas H. A Consensus-Based Interpretation of the Benchmark Evidence from South American Trials: Treatment of Intracranial Pressure Trial. J Neurotrauma. 2015 Nov 15;32(22):1722-4. doi: 10.1089/neu.2015.3976. Epub 2015 Aug 31.

  PMID: 26061135 BACKGROUND

• Hemphill JC 3rd, Greenberg SM, Anderson CS, Becker K, Bendok BR, Cushman M, Fung GL, Goldstein JN, Macdonald RL, Mitchell PH, Scott PA, Selim MH, Woo D; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology. Guidelines for the Management of Spontaneous Intracerebral Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Jul;46(7):2032-60. doi: 10.1161/STR.0000000000000069. Epub 2015 May 28.

  PMID: 26022637 BACKGROUND

• Chesnut R, Videtta W, Vespa P, Le Roux P; Participants in the International Multidisciplinary Consensus Conference on Multimodality Monitoring. Intracranial pressure monitoring: fundamental considerations and rationale for monitoring. Neurocrit Care. 2014 Dec;21 Suppl 2:S64-84. doi: 10.1007/s12028-014-0048-y.

  PMID: 25208680 BACKGROUND

• Le Roux P, Menon DK, Citerio G, Vespa P, Bader MK, Brophy GM, Diringer MN, Stocchetti N, Videtta W, Armonda R, Badjatia N, Boesel J, Chesnut R, Chou S, Claassen J, Czosnyka M, De Georgia M, Figaji A, Fugate J, Helbok R, Horowitz D, Hutchinson P, Kumar M, McNett M, Miller C, Naidech A, Oddo M, Olson D, O'Phelan K, Provencio JJ, Puppo C, Riker R, Robertson C, Schmidt M, Taccone F; Neurocritical Care Society; European Society of Intensive Care Medicine. Consensus summary statement of the International Multidisciplinary Consensus Conference on Multimodality Monitoring in Neurocritical Care : a statement for healthcare professionals from the Neurocritical Care Society and the European Society of Intensive Care Medicine. Intensive Care Med. 2014 Sep;40(9):1189-209. doi: 10.1007/s00134-014-3369-6. Epub 2014 Aug 20.

  PMID: 25138226 BACKGROUND

• Stocchetti N, Maas AI. Traumatic intracranial hypertension. N Engl J Med. 2014 Sep 4;371(10):972. doi: 10.1056/NEJMc1407775. No abstract available.

  PMID: 25184881 BACKGROUND

• Wilson JT, Pettigrew LE, Teasdale GM. Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J Neurotrauma. 1998 Aug;15(8):573-85. doi: 10.1089/neu.1998.15.573.

  PMID: 9726257 BACKGROUND

• Cossu G, Messerer M, Stocchetti N, Levivier M, Daniel RT, Oddo M. Intracranial pressure and outcome in critically ill patients with aneurysmal subarachnoid hemorrhage: a systematic review. Minerva Anestesiol. 2016 Jun;82(6):684-96. Epub 2016 Apr 5.

  PMID: 27045637 BACKGROUND

• Citerio G, Oddo M, Taccone FS. Recommendations for the use of multimodal monitoring in the neurointensive care unit. Curr Opin Crit Care. 2015 Apr;21(2):113-9. doi: 10.1097/MCC.0000000000000179.

  PMID: 25689123 BACKGROUND

• Stocchetti N, Le Roux P, Vespa P, Oddo M, Citerio G, Andrews PJ, Stevens RD, Sharshar T, Taccone FS, Vincent JL. Clinical review: neuromonitoring - an update. Crit Care. 2013 Jan 15;17(1):201. doi: 10.1186/cc11513.

  PMID: 23320763 BACKGROUND

• Robba C, Graziano F, Guglielmi A, Rebora P, Galimberti S, Taccone FS, Citerio G; SYNAPSE-ICU Investigators. Treatments for intracranial hypertension in acute brain-injured patients: grading, timing, and association with outcome. Data from the SYNAPSE-ICU study. Intensive Care Med. 2023 Jan;49(1):50-61. doi: 10.1007/s00134-022-06937-1. Epub 2023 Jan 9.

  PMID: 36622462 DERIVED

• Dallagiacoma S, Robba C, Graziano F, Rebora P, Hemphill JC, Galimberti S, Citerio G; SYNAPSE-ICU Investigators. Intracranial Pressure Monitoring in Patients With Spontaneous Intracerebral Hemorrhage: Insights From the SYNAPSE-ICU Study. Neurology. 2022 Jul 12;99(2):e98-e108. doi: 10.1212/WNL.0000000000200568. Epub 2022 May 4.

  PMID: 35508390 DERIVED

• Robba C, Graziano F, Rebora P, Elli F, Giussani C, Oddo M, Meyfroidt G, Helbok R, Taccone FS, Prisco L, Vincent JL, Suarez JI, Stocchetti N, Citerio G; SYNAPSE-ICU Investigators. Intracranial pressure monitoring in patients with acute brain injury in the intensive care unit (SYNAPSE-ICU): an international, prospective observational cohort study. Lancet Neurol. 2021 Jul;20(7):548-558. doi: 10.1016/S1474-4422(21)00138-1.

  PMID: 34146513 DERIVED

• Citerio G, Prisco L, Oddo M, Meyfroidt G, Helbok R, Stocchetti N, Taccone F, Vincent JL, Robba C, Elli F, Sala E, Vargiolu A, Lingsma H. International prospective observational study on intracranial pressure in intensive care (ICU): the SYNAPSE-ICU study protocol. BMJ Open. 2019 Apr 20;9(4):e026552. doi: 10.1136/bmjopen-2018-026552.

  PMID: 31005932 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Subarachnoid Hemorrhage; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giuseppe Citerio

  University Milano Bicocca

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 22, 2017
• Study Start: March 15, 2018
• Primary Completion: December 31, 2019
• Study Completion: June 11, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)