Altered Mental Status Clinical Trial
Official title:
Impact of microEEG on Clinical Management and Outcomes of Emergency Department (ED) Patients With Altered Mental Status
Verified date | February 2013 |
Source | Bio-Signal Group Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 149 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Kings County Hospital Center | Brooklyn | New York |
United States | SUNY Downstate Medical Center | Brookyln | New York |
Lead Sponsor | Collaborator |
---|---|
Bio-Signal Group Corp. | Kings County Hospital Center, National Institute of Neurological Disorders and Stroke (NINDS), State University of New York - Downstate Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of ED management | Primary outcome: Change in management (Diagnosis and Therapy) | 4-6 hours of arrival | |
Secondary | Other Outcomes | Secondary Outcome: Length of stay in Hospital, Length of stay in ED, In-hospital mortality, Type of ED Disposition and Type of hospital disposition. | 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 |
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