EEG Monitoring in the Emergency Department

NCT04070521 | Unknown

• 1 other identifier: 2018P002483
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Drug Overdose; Substance Abuse; Alcohol Abuse

Keywords

Electroencephalogram; Opioids; Alcohol; Benzodiazepines; Alpha-2 agonists; Propofol; Ketamine; Marijuana; Neuromechanisms of intoxicants

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Observational EEG Monitoring

Other: Observational EEG Monitoring

Interventions

Observational EEG Monitoring OTHER

Subjects will be monitored with electroencephalogram (EEG) after arriving to the Emergency Department with suspected overdose

Observational EEG Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Drug Overdose; Substance-Related Disorders; Alcoholism; Marijuana Abuse

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Chemically-Induced Disorders; Mental Disorders; Alcohol-Related Disorders

Study Officials

• Patrick L Purdon, Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nathaniel M. Sims Endowed Chair in Anesthesia Innovation and Bioengineering

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: September 6, 2019
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)