Putting Electroencephalography (EEG) in the Emergency Department

Tracking Information
First Submitted Date ICMJE	August 4, 2012
First Posted Date ICMJE	August 23, 2012
Last Update Posted Date	February 15, 2013
Study Start Date ICMJE	August 2012
Actual Primary Completion Date	December 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 21, 2012)	Change of ED management [ Time Frame: 4-6 hours of arrival ]; Primary outcome: Change in management (Diagnosis and Therapy)
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01671475 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: February 13, 2013)	Other Outcomes [ Time Frame: From date of randomization until the date of discharge from the hospital or date of in-hospital death from any cause, whichever comes first, assessed up to 90 days ]; Secondary Outcome: Length of stay in Hospital, Length of stay in ED, In-hospital mortality, Type of ED Disposition and Type of hospital disposition.
Original Secondary Outcome Measures ICMJE; (submitted: August 21, 2012)	Other Outcomes [ Time Frame: From date of randomization until the date of discharge from the hospital or date of in-hospital death from any cause, whichever comes first, assessed up to 90 days ]; Secondary Outcome: Length of stay in Hospital, Length of stay in ED, Glasgow Outcome Scale (GOS), In-hospital mortality, Type of ED Disposition and Type of hospital disposition.
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Putting Electroencephalography (EEG) in the Emergency Department
Official Title ICMJE	Impact of microEEG on Clinical Management and Outcomes of Emergency Department (ED) Patients With Altered Mental Status
Brief Summary	The proposed study aims to test the impact of microEEG on clinical management (diagnosis and treatment) of emergency department patients with Altered Mental Status (AMS). The study will utilize a portable, wireless, FDA-approved device (microEEG) as the intervention. Patients will be randomized to routine care plus microEEG (experimental arm) or routine care alone (control arm). The investigators hypothesize that incorporating microEEG in the work up of patients with AMS will impact the clinical management of these patients.
Detailed Description	Approximately, 4% and 10% of emergency department (ED) patients in the United States present with altered mental status (AMS). According to previous studies, close to 30% of AMS cases occur due to neurological etiologies. Among these pathologies are non-convulsive seizures (NCS) and non-convulsive status epilepticus (NCSE). In our previous study, the investigators established that approximately 4% (95% confidence interval, 2-8%) of ED patients with AMS suffer from NCS and NCSE. Our study also revealed that 78% of the ED patient with AMS have some form of EEG abnormality. NCS and NCSE are difficult to diagnose especially in AMS patients because performing a thorough physical examination or obtaining medical history is often impossible in altered patients. Definitive diagnosis of NCS/NCSE requires electroencephalography (EEG), a test that records brain electrical activity and provides information about the brain function. Unfortunately, obtaining an EEG in the ED can be challenging. This requires transporting an EEG machine to patient's bedside, where space limitations and presence of variety of monitors and devices, especially in over-crowded EDs render this practice difficult. In many institutions an EEG service is not offered after work hours due to the unavailability of 24/7 EEG technologist coverage and real-time electroencephalographer interpretation. As a result of the aforementioned limitations, ED physicians may refrain from ordering EEG. The wireless portable EEG device (microEEG) designed by the Bio-Signal Group was designed to address these limitations. With minimal training, ED personnel could use this small, microEEG device to obtain an EEG. The recording then can be wirelessly transmitted to a host computer via a secure network connection to the neurology experts who could interpret the EEG. Incorporating microEEG in the initial workup of patients with AMS could help the ED attending rule out NCS/NCSE and focus on other diagnoses. Alternatively, if the presence of NCS is confirmed by EEG, the treatment could be initiated early and potentially reduce morbidity or mortality. The investigators hypothesize that incorporating EEG in the work of ED patients with AMS could impact the management(diagnosis and treatment)of these patients and influence their clinical outcome. Sample size: Our sample size analysis using data one published related study reveled that the study would need 65 patients in each group (total n:130). However, the investigators plan to perform an interim analysis after enrolling half of this target sample and adjust the sample size calculation based on the collected data if necessary.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Diagnostic
Condition ICMJE	Altered Mental Status
Intervention ICMJE	Device: microEEG (Bio-Signal microEEG); At the core, the Bio-Signal microEEG, is an FDA approved miniature, battery-operated, multi-channel, and portable system that records wideband bioelectric signals. The microEEG combines the characteristics of low noise and small size, due to a number of fundamental design characteristics. It records, amplifies, and digitizes the signals at a point very close to the electrodes. This allows the length of the wires between electrodes and the recorder's amplifiers to be very short, keeping them out of the way. Short wires also reduce any inconvenience signal artifacts or other problems that may be associated with the length of the wires. The microEEG's dimensions are about 2"x2"x1".
Study Arms	Experimental: Routine care plus microEEG Subjects allocated to this group will undergo an EEG using microEEG device in addition to their routine care. The microEEG device will be used with commercially available electrodes in a headpiece configuration. Intervention: Device: microEEG (Bio-Signal microEEG); No Intervention: Routine care only (control group) Subjects allocated to the control group will receive routine care without microEEG. The treating physician may request a standard EEG, which will be performed by the hospital EEG laboratory, if available.
Publications *	Zehtabchi S, Abdel Baki SG, Omurtag A, Sinert R, Chari G, Roodsari GS, Weedon J, Fenton AA, Grant AC. Effect of microEEG on clinical management and outcomes of emergency department patients with altered mental status: a randomized controlled trial. Acad Emerg Med. 2014 Mar;21(3):283-91. doi: 10.1111/acem.12324. Erratum in: Acad Emerg Med. 2014 Jun;21(6):715.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 13, 2013)	149
Original Estimated Enrollment ICMJE; (submitted: August 21, 2012)	130
Actual Study Completion Date	December 2012
Actual Primary Completion Date	December 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: ED patients ≥ 18 years old with AMS. Exclusion Criteria: Patients with apparent and immediately correctable cause of AMS (determined by ED attending during initial evaluation) that include: Fingerstick or serum glucose less than 60mg/dl Hypothermia (Hypothermia is defined as any body temperature below 35.0 C [95.0 F]). Hyperthermia, heat exhaustion or heat stroke Opioid overdose responding to Narcan.; Patients who cannot undergo EEG recordings for any reason (e.g. severe scalp injury).; Hemodynamically unstable patients(SBP <90mm Hg); Patients who are uncooperative or combative.; Patients transferred out of ED before enrollment.; Patients with obvious tonic-clonic or focal seizures in the ED. Note: Patients with hypoglycemia who do not return to their baseline level of mental status within 30 minutes of correcting their blood glucose level, will be enrolled. Similarly, patients who had an obvious seizure in the ED but do not return to their baseline mental status within 15 minutes will also be enrolled.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01671475
Other Study ID Numbers ICMJE	EDEEG; RC3NS070658 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Bio-Signal Group Corp.
Study Sponsor ICMJE	Bio-Signal Group Corp.
Collaborators ICMJE	National Institute of Neurological Disorders and Stroke (NINDS); State University of New York - Downstate Medical Center; Kings County Hospital Center
Investigators ICMJE	Principal Investigator: Shahriar Zehtabchi, MD Physician
PRS Account	Bio-Signal Group Corp.
Verification Date	February 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP