Ceribell Delirium Data Collection Study

NCT04962815 | Recruiting FDA Device

• 1 other identifier: 2021-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 7

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.

Conditions

Delirium

Keywords

delirium; EEG; Electroencephalogram

Outcome Measures

Primary Outcomes (2)

• Perform Confusion Assessment Method for the ICU (CAM-ICU) assessment

  Research coordinator will perform and collect CAM-ICU assessment data on study subjects

  3 times per day, for a maximum of six (6) days

• Perform Electroencephalogram (EEG) Test

  Record and collect EEG brain waves on study subjects using Ceribell Rapid Response EEG to assess multiple time-frequency EEG features to differentiate between delirium positive and delirium negative patients.

  6-8 hours per day, for a maximum of six (6) days

Interventions

Electroencephalogram (EEG) Test DEVICE

EEG test and delirium assessments will be performed on subjects experiencing delirium in the ICU.

Also known as: Delirium Assessments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who experience at least one delirious episode during their ICU stay

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Ceribell Inc.: lead

Study Sites (7)

Stanford University

Stanford, California, 94305, United States

ACTIVE NOT RECRUITING

Naples Community Hospital

Naples, Florida, 34102, United States

ACTIVE NOT RECRUITING

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

ACTIVE NOT RECRUITING

Mercy

St Louis, Missouri, 63141, United States

ACTIVE NOT RECRUITING

Cooper Health

Camden, New Jersey, 08103, United States

ACTIVE NOT RECRUITING

UNC Health Rex

Raleigh, North Carolina, 27607, United States

ACTIVE NOT RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 15082703 BACKGROUND

• 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.

  PMID: 18580517 BACKGROUND

• 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.

  PMID: 23263581 BACKGROUND

• 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.

  PMID: 28601132 BACKGROUND

• 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.

  PMID: 28263192 BACKGROUND

• 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.

  PMID: 31337404 BACKGROUND

• 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.

  PMID: 24067500 BACKGROUND

• 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.

  PMID: 28393426 BACKGROUND

• 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.

  PMID: 11445689 BACKGROUND

• Kaplan PW. The EEG in metabolic encephalopathy and coma. J Clin Neurophysiol. 2004 Sep-Oct;21(5):307-18.

  PMID: 15592005 BACKGROUND

MeSH Terms

Conditions

Delirium

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Jose Maldonado, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Timothy Girard, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Hofmann, MSN

CONTACT

800-436-0826; michelle.hofmann@ceribell.com

Jessy Dorn, PhD

CONTACT

800-436-0826; jessy.dorn@ceribell.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 15, 2021
• Study Start: November 10, 2021
• Primary Completion: December 31, 2025
• Study Completion: April 1, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (7)