Putting Electroencephalography (EEG) in the Emergency Department

This study has been completed.
Sponsor:
Collaborators:
State University of New York - Downstate Medical Center
Kings County Hospital Center
Information provided by (Responsible Party):
Bio-Signal Group Corp.
ClinicalTrials.gov Identifier:
NCT01671475
First received: August 4, 2012
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Altered Mental Status
Device: microEEG (Bio-Signal microEEG)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Impact of microEEG on Clinical Management and Outcomes of Emergency Department (ED) Patients With Altered Mental Status

Further study details as provided by Bio-Signal Group Corp.:

Primary Outcome Measures:
  • Change of ED management [ Time Frame: 4-6 hours of arrival ] [ Designated as safety issue: No ]
    Primary outcome: Change in management (Diagnosis and Therapy)


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Secondary Outcome: Length of stay in Hospital, Length of stay in ED, In-hospital mortality, Type of ED Disposition and Type of hospital disposition.


Enrollment: 149
Study Start Date: August 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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".
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

ED patients ≥ 18 years old with AMS.

Exclusion Criteria:

  1. 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.
  2. Patients who cannot undergo EEG recordings for any reason (e.g. severe scalp injury).
  3. Hemodynamically unstable patients(SBP <90mm Hg)
  4. Patients who are uncooperative or combative.
  5. Patients transferred out of ED before enrollment.
  6. 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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01671475

Locations
United States, New York
Kings County Hospital Center
Brooklyn, New York, United States, 11203
SUNY Downstate Medical Center
Brookyln, New York, United States, 11203
Sponsors and Collaborators
Bio-Signal Group Corp.
State University of New York - Downstate Medical Center
Kings County Hospital Center
Investigators
Principal Investigator: Shahriar Zehtabchi, MD Physician
  More Information

No publications provided by Bio-Signal Group Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bio-Signal Group Corp.
ClinicalTrials.gov Identifier: NCT01671475     History of Changes
Other Study ID Numbers: EDEEG, RC3NS070658
Study First Received: August 4, 2012
Last Updated: February 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Bio-Signal Group Corp.:
Altered Mental Status
Non-convulsive seizure
Electroencephalography

Additional relevant MeSH terms:
Emergencies
Mental Disorders
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014