- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04070521
EEG Monitoring in the Emergency Department
July 27, 2023 updated by: Patrick L. Purdon, Massachusetts General Hospital
Observational Study of EEG Monitoring of Patients in the Emergency Department
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Observational EEG Monitoring
|
Subjects will be monitored with electroencephalogram (EEG) after arriving to the Emergency Department with suspected overdose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Electroencephalogram (EEG)
Time Frame: 24 hours
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Patrick L Purdon, Ph.D., Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 6, 2019
Primary Completion (Actual)
October 31, 2019
Study Completion (Estimated)
October 31, 2024
Study Registration Dates
First Submitted
August 23, 2019
First Submitted That Met QC Criteria
August 26, 2019
First Posted (Actual)
August 28, 2019
Study Record Updates
Last Update Posted (Actual)
August 1, 2023
Last Update Submitted That Met QC Criteria
July 27, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018P002483
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to share IPD with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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