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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroencephalogram (EEG) Test | Device | EEG test and delirium assessments will be performed on subjects experiencing delirium in the ICU. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria: All must be present
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.
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Subjects who experience at least one delirious episode during their ICU stay
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michelle Hofmann, MSN | Contact | 800-436-0826 | michelle.hofmann@ceribell.com | |
| Jessy Dorn, PhD | Contact | 800-436-0826 | jessy.dorn@ceribell.com |
| Name | Affiliation | Role |
|---|---|---|
| Jose Maldonado, MD | Stanford University | Principal Investigator |
| Timothy Girard, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Active, not recruiting | Stanford | California | 94305 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15082703 | Background | 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. | |
| 18580517 | 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. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
Site investigators will have access to the participant EEG data via Ceribell EEG portal. In addition, site investigators will have access to delirium assessments conducted for study purposes.
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004569 | Electroencephalography |
| ID | Term |
|---|---|
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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| Naples Community Hospital |
| Active, not recruiting |
| Naples |
| Florida |
| 34102 |
| United States |
| University of Iowa Hospitals & Clinics | Active, not recruiting | Iowa City | Iowa | 52242 | United States |
| Mercy | Active, not recruiting | St Louis | Missouri | 63141 | United States |
| Cooper Health | Active, not recruiting | Camden | New Jersey | 08103 | United States |
| UNC Health Rex | Active, not recruiting | Raleigh | North Carolina | 27607 | United States |
| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
|
| 23263581 | 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. |
| 28601132 | 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. |
| 28263192 | 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. |
| 31337404 | 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. |
| 24067500 | 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. |
| 28393426 | 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. |
| 11445689 | 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. |
| 15592005 | Background | Kaplan PW. The EEG in metabolic encephalopathy and coma. J Clin Neurophysiol. 2004 Sep-Oct;21(5):307-18. |
This website is password protected and the de-identified individual participant data is only available to participating research sites. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |