Ceribell Delirium Data Collection Study

Delirium Clinical Trial

Official title:

Ceribell Delirium Data Collection Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04962815
• Other study ID #: 2021-01
• Status: Recruiting
• Start date: November 10, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Ceribell Inc.
• Contact: Michelle Hofmann, MSN
• Phone: 800-436-0826
• Email: michelle.hofmann[@]ceribell.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium

Intervention

Device:
• Electroencephalogram (EEG) Test
EEG test and delirium assessments will be performed on subjects experiencing delirium in the ICU.

Locations

Country	Name	City	State
United States	Cooper Health	Camden	New Jersey
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	Naples Community Hospital	Naples	Florida
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	UNC Health Rex	Raleigh	North Carolina
United States	Mercy	Saint Louis	Missouri
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Ceribell Inc.

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View 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. — View Citation

Kaplan PW. The EEG in metabolic encephalopathy and coma. J Clin Neurophysiol. 2004 Sep-Oct;21(5):307-18. — View 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. — View 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. — View 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. — View 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. Erratum In: Crit Care Med. 2013 Apr;41(4):e41. Pandhvaripande, Pratik P [corrected to Pandharipande, Pratik P]. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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