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Cerebral Oximetry in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT03769740
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Brian O'Neil, Wayne State University

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

Condition or disease Intervention/treatment
Cardiac Death Cardiac Arrest Emergencies Device: Cerebral Oximetry

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cerebral Oximetry Cardiac Arrest Patients
Actual Study Start Date : May 1, 2009
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Group/Cohort Intervention/treatment
CPR Group Device: Cerebral Oximetry
Non invasive, near infrared spectroscopy cerebral oximetry




Primary Outcome Measures :
  1. Neurological Outcome [ Time Frame: Discharge from the hospital and/or up to one year ]
    Glasgow Outcome Scale



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to the Emergency Department experiencing non-traumatic cardiac arrest or arriving post non-traumatic cardiac arrest
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769740


Contacts
Contact: Brian J O'Neil, MD 3139932530 boneil@med.wayne.edu
Contact: Patrick B Medado 3135777500 pbmedado@med.wayne.edu

Locations
United States, Michigan
DMC Detroit Receiving Hospital - Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Brian J O'Neil, MD    313-993-2530    boneil@med.wayne.edu   
Principal Investigator: Brian J O'Neil, MD         
DMC Sinai-Grace Hospital Recruiting
Detroit, Michigan, United States, 48235
Contact: Thomas Mazzocco, RN    313-993-2530    tmazzocco@med.wayne.edu   
Principal Investigator: Brian J O'Neil, MD         
Sponsors and Collaborators
Wayne State University

Responsible Party: Brian O'Neil, Professor and Chair of Department of Emergency Medicine, Wayne State University
ClinicalTrials.gov Identifier: NCT03769740     History of Changes
Other Study ID Numbers: 047609MP4E
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Brian O'Neil, Wayne State University:
cardiac arrest, cardiac death, CPR, neurologic prognostication, emergency medicine,

Additional relevant MeSH terms:
Emergencies
Heart Arrest
Death
Disease Attributes
Pathologic Processes
Heart Diseases
Cardiovascular Diseases