Putting Electroencephalography (EEG) in the Emergency Department
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ClinicalTrials.gov Identifier: NCT01671475 |
Recruitment Status
:
Completed
First Posted
: August 23, 2012
Last Update Posted
: February 15, 2013
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Tracking Information | ||||
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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 |
Change of ED management [ Time Frame: 4-6 hours of arrival ] Primary outcome: Change in management (Diagnosis and Therapy)
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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 |
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.
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Original Secondary Outcome Measures ICMJE |
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.
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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. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Diagnostic |
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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". |
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Study Arms |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
149 | |||
Original Estimated Enrollment ICMJE |
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:
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. |
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
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 ) |
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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 |
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Investigators ICMJE |
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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 |