EEG Monitoring in the Emergency Department | NCT04070521

Studies
EEG Monitoring in the Emergency Department

NCT04070521

Sponsor

Massachusetts General Hospital

Status

Unknown status

Last Update Posted

Aug 1, 2023Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Drug Overdose
Substance Abuse
Alcohol Abuse

Interventions

Observational EEG Monitoring

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 6, 2019Actual

Primary Completion Date

Oct 31, 2019Actual

Completion Date

Oct 31, 2024Estimated

First Submitted Date

Aug 23, 2019

First Submission Date that Met QC Criteria

Aug 26, 2019

First Posted Date

Aug 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2023

Last Update Posted Date

Aug 1, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Patrick L. Purdon, Nathaniel M. Sims Endowed Chair in Anesthesia Innovation and Bioengineering, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Name	Class
Brigham and Women's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational EEG Monitoring			Other: Observational EEG Monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational EEG Monitoring	Other	Subjects will be monitored with electroencephalogram (EEG) after arriving to the Emergency Department with suspected overdose	Observational EEG Monitoring

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrick L Purdon, Ph.D.	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

There is no plan to share IPD with other researchers.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D062787	Drug Overdose
D019966	Substance-Related Disorders
D000437	Alcoholism
D002189	Marijuana Abuse

Ancestor Terms

ID	Term
D063487	Prescription Drug Misuse
D000076064	Drug Misuse
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

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Browse Branches

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