Clinical trial NCT04962815: Ceribell Delirium Data Collection Study
Official title: Ceribell Delirium Data Collection Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Delirium
Keywords: delirium
EEG
Electroencephalogram
Lead sponsor: Ceribell Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who experience at least one delirious episode during their ICU stay

Brief summary: This study is designed as a prospective, non-randomized, observational clinical study. The study will collect clinical and rrEEG (Ceribell EEG) data when monitoring subjects for delirium subtypes. EEG and clinical data will be collected for the development of future software algorithms to assess the presence and severity of delirium.


Eligibility criteria: Inclusion Criteria: All must be present

* Age is 18 years or older
* Admitted to the Intensive Care Unit (ICU)
* Subject must be fluent in the language in which the delirium assessment is performed

Exclusion Criteria: All must be absent

- Any condition that prevents use of the Ceribell EEG system on the subject for the entire anticipated EEG monitoring period. Examples may include: Craniectomy with missing bone flap in an area where Ceribell EEG electrodes are placed. Expected use of continuous clinical EEG for the entire anticipated monitoring period.

Primary outcomes:
measure: Perform Confusion Assessment Method for the ICU (CAM-ICU) assessment
timeFrame: 3 times per day, for a maximum of six (6) days
measure: Perform Electroencephalogram (EEG) Test
timeFrame: 6-8 hours per day, for a maximum of six (6) days
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Naples
country: United States
facility: Naples Community Hospital
state: Florida
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Saint Louis
country: United States
facility: Mercy
state: Missouri
city: Camden
country: United States
facility: Cooper Health
state: New Jersey
city: Raleigh
country: United States
facility: UNC Health Rex
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: Stanford University
name: Jose Maldonado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Timothy Girard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
citation: Pandharipande P, Cotton BA, Shintani A, Thompson J, Pun BT, Morris JA Jr, Dittus R, Ely EW. Prevalence and risk factors for development of delirium in surgical and trauma intensive care unit patients. J Trauma. 2008 Jul;65(1):34-41. doi: 10.1097/TA.0b013e31814b2c4d.
citation: McPherson JA, Wagner CE, Boehm LM, Hall JD, Johnson DC, Miller LR, Burns KM, Thompson JL, Shintani AK, Ely EW, Pandharipande PP. Delirium in the cardiovascular ICU: exploring modifiable risk factors. Crit Care Med. 2013 Feb;41(2):405-13. doi: 10.1097/CCM.0b013e31826ab49b.
citation: Maldonado JR. Acute Brain Failure: Pathophysiology, Diagnosis, Management, and Sequelae of Delirium. Crit Care Clin. 2017 Jul;33(3):461-519. doi: 10.1016/j.ccc.2017.03.013.
citation: Khan BA, Perkins AJ, Gao S, Hui SL, Campbell NL, Farber MO, Chlan LL, Boustani MA. The Confusion Assessment Method for the ICU-7 Delirium Severity Scale: A Novel Delirium Severity Instrument for Use in the ICU. Crit Care Med. 2017 May;45(5):851-857. doi: 10.1097/CCM.0000000000002368.
citation: Shenkin SD, Fox C, Godfrey M, Siddiqi N, Goodacre S, Young J, Anand A, Gray A, Hanley J, MacRaild A, Steven J, Black PL, Tieges Z, Boyd J, Stephen J, Weir CJ, MacLullich AMJ. Delirium detection in older acute medical inpatients: a multicentre prospective comparative diagnostic test accuracy study of the 4AT and the confusion assessment method. BMC Med. 2019 Jul 24;17(1):138. doi: 10.1186/s12916-019-1367-9.
citation: Maclullich AM, Anand A, Davis DH, Jackson T, Barugh AJ, Hall RJ, Ferguson KJ, Meagher DJ, Cunningham C. New horizons in the pathogenesis, assessment and management of delirium. Age Ageing. 2013 Nov;42(6):667-74. doi: 10.1093/ageing/aft148. Epub 2013 Sep 25.
citation: Tieges Z, Evans JJ, Neufeld KJ, MacLullich AMJ. The neuropsychology of delirium: advancing the science of delirium assessment. Int J Geriatr Psychiatry. 2018 Nov;33(11):1501-1511. doi: 10.1002/gps.4711. Epub 2017 Apr 9.
citation: Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R, Speroff T, Gautam S, Bernard GR, Inouye SK. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001 Jul;29(7):1370-9. doi: 10.1097/00003246-200107000-00012.
citation: Kaplan PW. The EEG in metabolic encephalopathy and coma. J Clin Neurophysiol. 2004 Sep-Oct;21(5):307-18.