Altered Mental Status Clinical Trial
Official title:
Impact of microEEG on Clinical Management and Outcomes of Emergency Department (ED) Patients With Altered Mental Status
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.
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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