NCT01671475

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 23, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

4 months

First QC Date

August 4, 2012

Last Update Submit

February 13, 2013

Conditions

Altered Mental Status

Keywords

Altered Mental StatusNon-convulsive seizureElectroencephalography

Outcome Measures

Primary Outcomes (1)

  • Change of ED management

    Primary outcome: Change in management (Diagnosis and Therapy)

    4-6 hours of arrival

Secondary Outcomes (1)

  • Other Outcomes

    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

Study Arms (2)

Routine care plus microEEG

EXPERIMENTAL

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)

Routine care only (control group)

NO INTERVENTION

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.

Interventions

microEEG (Bio-Signal microEEG)DEVICE

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".

Routine care plus microEEG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ED patients ≥ 18 years old with AMS.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kings County Hospital Center

Brooklyn, New York, 11203, United States

Location

SUNY Downstate Medical Center

Brookyln, New York, 11203, United States

Location

Related Publications (1)

  • 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.

    PMID: 24628753DERIVED

Study Officials

  • Shahriar Zehtabchi, MD

    Physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2012

First Posted

August 23, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

US(2)