Cerebral Oximetry and NIRS in Cardiac Arrest Patients | NCT03769740

Studies
Cerebral Oximetry and NIRS in Cardiac Arrest Patients

NCT03769740

Sponsor

Wayne State University

Status

Unknown status

Last Update Posted

Feb 7, 2019Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Cardiac Death
Cardiac Arrest
Emergencies

Interventions

Cerebral Oximetry

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

Feb 2019

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

May 1, 2009Actual

Primary Completion Date

Dec 31, 2019Estimated

Completion Date

Dec 31, 2019Estimated

First Submitted Date

Nov 8, 2018

First Submission Date that Met QC Criteria

Dec 6, 2018

First Posted Date

Dec 7, 2018Actual

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

Feb 5, 2019

Last Update Posted Date

Feb 7, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Brian O'Neil, Professor and Chair of Department of Emergency Medicine, Wayne State UniversityPrincipal Investigator

Lead Sponsor

Wayne State UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

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 is an observational study to define the role and future applications of cerebral oximetry in cardiac arrest 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

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CPR Group			Device: Cerebral Oximetry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cerebral Oximetry	Device	Non invasive, near infrared spectroscopy cerebral oximetry	CPR Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ROSC	Return of spontaneous circulation	During ED resuscitation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years
Non-traumatic cardiac arrest or post non-traumatic cardiac arrest
No purposeful response to verbal or noxious stimuli

Exclusion Criteria:

Age < 18 years
Open head injury/trauma

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 presenting to the Emergency Department experiencing non-traumatic cardiac arrest or arriving post non-traumatic cardiac arrest

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Brian J O'Neil, MD	Contact	3139932530		boneil@med.wayne.edu
Patrick B Medado	Contact	3135777500		pbmedado@med.wayne.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
DMC Detroit Receiving Hospital - Wayne State University	Recruiting	Detroit	Michigan	48201	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003643	Death
D006323	Heart Arrest
D004630	Emergencies

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided