Rapid-Response EEG in Children With Suspected Status Epilepticus

NCT06564662 | Recruiting

• 1 other identifier: MMC-CHAM-PCCM-2021-13666
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Seizures are common in children (\~350 per 100,000 patients per year) and require immediate medical attention. If the seizure is prolonged (\> 5 minutes) it is called status epilepticus and delayed treatment leads to higher risk in drug resistance and brain injury. The current standard of care for children admitted to the ICU with established or suspected status epilepticus is to start a conventional continuous EEG study that helps diagnosing seizures by typical electro graphic patterns. It takes on average 4 hours to start and another two hours to obtain a reading by epileptologists. This is far beyond the time window of starting an EEG study (60 minutes) as recommended by the neurocritical care society. In adult ICUs, point of care "Rapid Response EEG" are becoming a new standard of care and our ICU adopted this practice in 2020. It can be easily placed by the ICU staff rather than a specifically trained EEG technician but has a lower resolution due to fewer leads (10 vs. 20). The purpose of this study is to determine wether and by how much time RR-EEG yields faster preliminary EEG reports that the previously available conventional EEG (cEEG) and wether the detection of electro graphic seizures is comparable. This is a retrospective cohort study following patients who are admitted to the PICU and are placed on either cEEG or RR-EEG for status epilepticus.

Conditions

Status Epilepticus; Coma

Keywords

Electroencephalography; Child; Intensive Care Units, Pediatric

Outcome Measures

Primary Outcomes (1)

• Time from order of electroencephalogram (EEG) to EEG reading

  EMR order placement as a surrogate for decision making to obtain an EEG. Report time of EEG was considered the time relevant information was available to the ICU team.

  up to 24 hours

Secondary Outcomes (3)

• Time from EEG order to start of EEG recording

  up to 24 hours

• Time from EEG start to first EEG reading report as documented in the electronic medical record

  up to 24 hours

• EEG description

  up to 24 hours

Interventions

Rapid Response EEG DEVICE

The Ceribell(R) Rapid Response EEG is a relatively new device that is becoming standard of care in the adult critical care. In this pediatric study the device will be placed by trained ICU physicians

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients with diminished level of consciousness and high suspicion for (non-convulsive) status epilepticus

You may qualify if:

• all patients with suspected status epilepticus as determined by the treating team in the pediatric ER or ICU

You may not qualify if:

• none

Sponsors & Collaborators

• Children's Hospital at Montefiore: lead

Study Sites (1)

Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

RECRUITING

Related Publications (11)

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  PMID: 1868801 BACKGROUND

• Aaberg KM, Gunnes N, Bakken IJ, Lund Soraas C, Berntsen A, Magnus P, Lossius MI, Stoltenberg C, Chin R, Suren P. Incidence and Prevalence of Childhood Epilepsy: A Nationwide Cohort Study. Pediatrics. 2017 May;139(5):e20163908. doi: 10.1542/peds.2016-3908. Epub 2017 Apr 5.

  PMID: 28557750 BACKGROUND

• Chin RF, Neville BG, Peckham C, Bedford H, Wade A, Scott RC; NLSTEPSS Collaborative Group. Incidence, cause, and short-term outcome of convulsive status epilepticus in childhood: prospective population-based study. Lancet. 2006 Jul 15;368(9531):222-9. doi: 10.1016/S0140-6736(06)69043-0.

  PMID: 16844492 BACKGROUND

• Raspall-Chaure M, Chin RFM, Neville BG, Bedford H, Scott RC. The epidemiology of convulsive status epilepticus in children: a critical review. Epilepsia. 2007 Sep;48(9):1652-1663. doi: 10.1111/j.1528-1167.2007.01175.x. Epub 2007 Jul 18.

  PMID: 17634062 BACKGROUND

• Quigg M, Shneker B, Domer P. Current practice in administration and clinical criteria of emergent EEG. J Clin Neurophysiol. 2001 Mar;18(2):162-5. doi: 10.1097/00004691-200103000-00007.

  PMID: 11435807 BACKGROUND

• Gururangan K, Razavi B, Parvizi J. Utility of electroencephalography: Experience from a U.S. tertiary care medical center. Clin Neurophysiol. 2016 Oct;127(10):3335-40. doi: 10.1016/j.clinph.2016.08.013. Epub 2016 Aug 24.

  PMID: 27611442 BACKGROUND

• Gainza-Lein M, Sanchez Fernandez I, Jackson M, Abend NS, Arya R, Brenton JN, Carpenter JL, Chapman KE, Gaillard WD, Glauser TA, Goldstein JL, Goodkin HP, Kapur K, Mikati MA, Peariso K, Tasker RC, Tchapyjnikov D, Topjian AA, Wainwright MS, Wilfong A, Williams K, Loddenkemper T; Pediatric Status Epilepticus Research Group. Association of Time to Treatment With Short-term Outcomes for Pediatric Patients With Refractory Convulsive Status Epilepticus. JAMA Neurol. 2018 Apr 1;75(4):410-418. doi: 10.1001/jamaneurol.2017.4382.

  PMID: 29356811 BACKGROUND

• Sanchez Fernandez I, Abend NS, Agadi S, An S, Arya R, Brenton JN, Carpenter JL, Chapman KE, Gaillard WD, Glauser TA, Goodkin HP, Kapur K, Mikati MA, Peariso K, Ream M, Riviello J Jr, Tasker RC, Loddenkemper T; Pediatric Status Epilepticus Research Group (pSERG). Time from convulsive status epilepticus onset to anticonvulsant administration in children. Neurology. 2015 Jun 9;84(23):2304-11. doi: 10.1212/WNL.0000000000001673. Epub 2015 May 6.

  PMID: 25948729 BACKGROUND

• Lowenstein DH, Alldredge BK. Status epilepticus at an urban public hospital in the 1980s. Neurology. 1993 Mar;43(3 Pt 1):483-8. doi: 10.1212/wnl.43.3_part_1.483.

  PMID: 8450988 BACKGROUND

• Brophy GM, Bell R, Claassen J, Alldredge B, Bleck TP, Glauser T, Laroche SM, Riviello JJ Jr, Shutter L, Sperling MR, Treiman DM, Vespa PM; Neurocritical Care Society Status Epilepticus Guideline Writing Committee. Guidelines for the evaluation and management of status epilepticus. Neurocrit Care. 2012 Aug;17(1):3-23. doi: 10.1007/s12028-012-9695-z.

  PMID: 22528274 BACKGROUND

• Fisher RS, Cross JH, French JA, Higurashi N, Hirsch E, Jansen FE, Lagae L, Moshe SL, Peltola J, Roulet Perez E, Scheffer IE, Zuberi SM. Operational classification of seizure types by the International League Against Epilepsy: Position Paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):522-530. doi: 10.1111/epi.13670. Epub 2017 Mar 8.

  PMID: 28276060 BACKGROUND

Related Links

• Ceribell Website
• Clarity (Ceribell ML algorithm)

MeSH Terms

Conditions

Status Epilepticus; Coma

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: August 21, 2024
• Study Start: December 9, 2021
• Primary Completion (Estimated): December 8, 2026
• Study Completion (Estimated): December 8, 2026
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

US (1)