Cardiac DeathNCT03769740
Cerebral Oximetry and NIRS in Cardiac Arrest Patients
An observational study of Cardiac Death and Cardiac Arrest, run by Wayne State University at 2 sites in United States.
Trial summary
This is an observational study to define the role and future applications of cerebral oximetry in cardiac arrest patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Death, Cardiac Arrest, Emergencies
- What is being tested?
- Cerebral Oximetry
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2009to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the Emergency Department experiencing non-traumatic cardiac arrest or arriving post non-traumatic cardiac arrest
Who may be able to join
- Age > 18 years
- Non-traumatic cardiac arrest or post non-traumatic cardiac arrest
- No purposeful response to verbal or noxious stimuli
Who cannot join
- Age < 18 years
- Open head injury/trauma
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
DMC Detroit Receiving Hospital - Wayne State University
Detroit, Michigan, 48201
Brian J O'Neil, MD, 313-993-2530, boneil@med.wayne.edu
Brian J O'Neil, MD
- Recruiting
DMC Sinai-Grace Hospital
Detroit, Michigan, 48235
Thomas Mazzocco, RN, 313-993-2530, tmazzocco@med.wayne.edu
Brian J O'Neil, MD
About this study
This is an observational study to define the role and future applications of cerebral oximetry in cardiac arrest patients.
- Conditions
- Cardiac Death, Cardiac Arrest, Emergencies
- Being tested
- Cerebral Oximetry
- Keywords
- cardiac arrest, cardiac death, CPR, neurologic prognostication, emergency medicine,
- Medical subject headings
- Death, Heart Arrest, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral OximetryDevice
Non invasive, near infrared spectroscopy cerebral oximetry
| Study group | Role | What they receive |
|---|---|---|
| CPR Group | Not described Receives: Device: Cerebral Oximetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROSC
Return of spontaneous circulation
Measured: During ED resuscitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start1 May 2009
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian O'Neil, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769740
- Sponsor's protocol ID
- 047609MP4E
- Status last verified
- Feb 2019
- First submitted
- 8 Nov 2018
- Last updated
- 7 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oximetry and NIRS in Cardiac Arrest Patients
- ClinicalTrials.gov ID
- NCT03769740
- Acronym / sponsor ID
- 047609MP4E
- Conditions
- Cardiac Death, Cardiac Arrest, Emergencies
- Keywords
- cardiac arrest, cardiac death, CPR, neurologic prognostication, emergency medicine,
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 1 May 2009 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study to define the role and future applications of cerebral oximetry in cardiac arrest patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPR Group | – | Device: Cerebral Oximetry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the Emergency Department experiencing non-traumatic cardiac arrest or arriving post non-traumatic cardiac arrest
Key inclusion criteria (3 listed)
- Age > 18 years
- Non-traumatic cardiac arrest or post non-traumatic cardiac arrest
- No purposeful response to verbal or noxious stimuli
Key exclusion criteria (2 listed)
- Age < 18 years
- Open head injury/trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebral OximetryNon invasive, near infrared spectroscopy cerebral oximetry | Device | CPR Group |
Primary outcome
ROSC
Time frame: During ED resuscitation
Return of spontaneous circulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Death and Cardiac Arrest, run by Wayne State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian J O'Neil, MD (3139932530, boneil@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROSC (time frame: During ED resuscitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2019.