Electroencephalography in Patients Resuscitated From Card... | NCT02344693

Studies
Electroencephalography in Patients Resuscitated From Cardiac Arrest

NCT02344693

Sponsor

Helsinki University Central Hospital

Status

Unknown status

Last Update Posted

Jun 21, 2018Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Cardiac Arrest
Heart Arrest

Interventions

Not provided

Countries

Finland

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

Jun 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2017Actual

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Jan 16, 2015

First Submission Date that Met QC Criteria

Jan 16, 2015

First Posted Date

Jan 26, 2015Estimated

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

Jun 20, 2018

Last Update Posted Date

Jun 21, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Johannes Björkman, Resident, Helsinki University Central HospitalPrincipal Investigator

Lead Sponsor

Helsinki University Central HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Sudden cardiac death can occur due to a multitude of causes. The underlying case can affect the overall prognosis. A return of spontaneous circulation not exceeding 30 minutes following a successful cardiopulmonary resuscitation is usually deemed imperative, if the patient is to survive. Monitors for evaluating the cardiac function during and after resuscitation are implemented on a daily basis (ekg, pulseoxymetry, blood pressure monitoring, cardiac sonography), but no devices for registration of the cortical brain activity exist. The aim of this study is to provide a 3-channel electroencephalogram using a prototype EEG/EKG adapter, connected to a Physio-Control LifePak 15 monitor/defibrillator, in patients who regain spontaneous circulation following non-traumatic cardiac arrest.

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

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prehospital EEG value in regard to patient discharge		60-min

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Witnessed Cardiac Arrest
Return of spontaneous circulation following cardiac arrest 10-40 min

Exclusion Criteria:

traumatic cardiac arrest
no consent from next-of-kin

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

Patients resuscitated from a non-traumatic cardiac arrest in a urban setting in southern Finland

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Johannes Björkman, MD	Contact			johannes.bjorkman@helsinki.fi
Tom Silfvast, MD, PhD	Contact	09 4711		tom.silfvast@hus.fi

Overall Officials

Name	Affiliation	Role
Johannes Björkman, MD	Helsinki University Central Hospital	Principal Investigator
Tom Silfvast, MD, PhD	Helsinki University Central Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Central Hospital	Recruiting	Helsinki		00029	Finland

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided