Cerebral Oximetry and NIRS in Cardiac Arrest Patients

• Sponsor: Wayne State University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03769740
• Collaborator: (none)
• Enrollment: 500
• Locations: 2
• Anticipated Duration (Months): 128
• Patients Per Site: 250
• Patients Per Site Per Month: 2

Study Details

Study Description

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	Phase
Cardiac Death; Cardiac Arrest; Emergencies	Device: Cerebral Oximetry

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Cerebral Oximetry and NIRS in Cardiac Arrest Patients
• Actual Study Start Date: May 1, 2009
• Anticipated Primary Completion Date: Dec 31, 2019
• Anticipated Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
CPR Group	Device: Cerebral Oximetry; Non invasive, near infrared spectroscopy cerebral oximetry

Outcome Measures

Primary Outcome Measures

1. ROSC [During ED resuscitation]

   Return of spontaneous circulation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DMC Detroit Receiving Hospital - Wayne State University	Detroit	Michigan	United States	48201
2	DMC Sinai-Grace Hospital	Detroit	Michigan	United States	48235

Sponsors and Collaborators

• Wayne State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Brian O'Neil, Professor and Chair of Department of Emergency Medicine, Wayne State University
• ClinicalTrials.gov Identifier: NCT03769740
• Other Study ID Numbers: 047609MP4E
• First Posted: Dec 7, 2018
• Last Update Posted: Feb 7, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Brian O'Neil, Professor and Chair of Department of Emergency Medicine, Wayne State University: cardiac arrest, cardiac death, CPR, neurologic prognostication, emergency medicine,
• Additional relevant MeSH terms: Heart Arrest; Emergencies; Death

Study Results

No Results Posted as of Feb 7, 2019