NCT03769740

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
9.5 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 7, 2019

Status Verified

February 1, 2019

Enrollment Period

10.7 years

First QC Date

November 8, 2018

Last Update Submit

February 5, 2019

Conditions

Cardiac DeathCardiac ArrestEmergencies

Keywords

cardiac arrest, cardiac death, CPR, neurologic prognostication, emergency medicine,

Outcome Measures

Primary Outcomes (1)

  • ROSC

    Return of spontaneous circulation

    During ED resuscitation

Study Arms (1)

CPR Group

Device: Cerebral Oximetry

Interventions

Cerebral OximetryDEVICE

Non invasive, near infrared spectroscopy cerebral oximetry

CPR Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Age \< 18 years
  • Open head injury/trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

DMC Detroit Receiving Hospital - Wayne State University

Detroit, Michigan, 48201, United States

RECRUITING

DMC Sinai-Grace Hospital

Detroit, Michigan, 48235, United States

RECRUITING

MeSH Terms

Conditions

DeathHeart ArrestEmergencies

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesDisease Attributes

Central Study Contacts

Brian J O'Neil, MD

CONTACT

3139932530boneil@med.wayne.edu

Patrick B Medado

CONTACT

3135777500pbmedado@med.wayne.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair of Department of Emergency Medicine

Study Record Dates

First Submitted

November 8, 2018

First Posted

December 7, 2018

Study Start

May 1, 2009

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 7, 2019

Record last verified: 2019-02

Locations

US(2)