EEG Monitoring in the Emergency Department

Substance Abuse Clinical Trial

Official title:

Observational Study of EEG Monitoring of Patients in the Emergency Department

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04070521
• Other study ID #: 2018P002483
• Status: Active, not recruiting
• Start date: September 6, 2019
• Est. completion date: October 31, 2024

Study information

• Verified date: July 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study seeks to investigate whether drug effects in suspected overdose patients could be identified using the electroencephalogram (EEG). From previous work it is known that different classes of anesthetic drugs have specific "EEG signatures" related to the drug mechanisms. Many of the drugs of abuse that are frequently encountered in overdose patients are similar or identical to anesthetic drugs. The hypothesis for this study is that the EEG could be used to characterize the brain effects of intoxicants using EEG in the ED setting. Such monitoring could one day help clinicians and first responders at the point-of-care make more informed decisions to improve the care of overdose patients.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients aged 18 years and older who present to the ED with suspected use of a potential drug of abuse

Exclusion Criteria:

• Hemodynamic instability or other acute medical condition for which the primary treating team does not thing it would be appropriate or safe for the study staff to approach the patient

• The patient has an overt head trauma or deformity of the face which would preclude application of the forehead EEG monitoring lead

• The patient has dermatological issues or skin conditions on the forehead

• The patient has known dementia and/or mental impairment

• The patient is a prisoner

• The patient is an employee or student at one of the study sites.

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Drug Overdose
• Emergencies
• Substance Abuse
• Substance-Related Disorders

Intervention

Other:
• Observational EEG Monitoring
Subjects will be monitored with electroencephalogram (EEG) after arriving to the Emergency Department with suspected overdose

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electroencephalogram (EEG)	Subject EEG activity following arrival to Emergency Department with suspected overdose, including EEG waveform, spectrum, spectrogram, and power in the slow (0.1-1 Hz), delta (1 to 4 Hz), theta (4 to 8 Hz), alpha (8 to 12 Hz), beta (12 to 25 Hz), and gamma (25 to 70 Hz) bands.	24 hours