Cardiac ArrestNCT01806844
Prehospital Cerebral Oxygenation During Cardiopulmonary Resuscitation (CPR)
An observational study of Cardiac Arrest, run by Hasselt University at 5 sites in Belgium.
Trial summary
Near infrared spectroscopy (NIRS) is a technique that measures regional cerebral oxygenation in a non-invasive manner. Through the use of near infrared light, the difference between oxygenated and deoxygenated hemoglobin can be measured. By applying the Beer-Lamber law, a numeric result can be calculated. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cardiac Arrest
- How many people
- 200 participants
- Where
- 5 sitesBelgium
- Study dates
- May 2013to Nov 2015
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: pre-hospital cardiac arrest
Who may be able to join
- >16 year
Who cannot join
- DNR code
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Belgium5 sites
Ziekenhuis netwerk Antwerpen
Antwerp, Antwerpen, 2000
GZA St Vincentius
Antwerp
Ziekenhuis Oost-Limburg
Genk, Limburg, 3600
Universitair ziekenhuis Leuven
Leuven, Vlaams Brabant, 3000
AZ Turnhout
Turnhout
About this study
Official title: Cerebral Oxygenation During Resuscitation and Post-resuscitation Phase
Near infrared spectroscopy (NIRS) is a technique that measures regional cerebral oxygenation in a non-invasive manner. Through the use of near infrared light, the difference between oxygenated and deoxygenated hemoglobin can be measured. By applying the Beer-Lamber law, a numeric result can be calculated. During a cardiac arrest, there is no stroke volume, no cardiac output and no cerebral perfusion. By using cerebral NIRS during out-of hospital cardiac arrest, low flow time and return of spontaneous circulation, this study wants to show the prognostic value of NIRS as extra monitoring.
- Conditions
- Cardiac Arrest
- Keywords
- Cardiac arrest, Cerebral oxygenation, Pre-hospital
- Medical subject headings
- Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
prognostic value
Prognostic value of cerebral oxygenation during CPR
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Responsible party
- Principal investigator, Cornelia Genbrugge, Hasselt University
- Investigators
- Cornelia Genbrugge, MD, Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806844
- Sponsor's protocol ID
- Copernicus I
- Status last verified
- Apr 2016
- First submitted
- 6 Mar 2013
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Meex I, De Deyne C, Dens J, Scheyltjens S, Lathouwers K, Boer W, Vundelinckx G, Heylen R, Jans F. Feasibility of absolute cerebral tissue oxygen saturation during cardiopulmonary resuscitation. Crit Care. 2013 Mar 1;17(2):R36. doi: 10.1186/cc12546.
PubMed 23448653
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oxygenation During Resuscitation and Post-resuscitation Phase
- ClinicalTrials.gov ID
- NCT01806844
- Acronym / sponsor ID
- Copernicus I
- Conditions
- Cardiac Arrest
- Keywords
- Cardiac arrest, Cerebral oxygenation, Pre-hospital
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Study start
- May 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 7 Mar 2013 (estimated)
- 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.
Near infrared spectroscopy (NIRS) is a technique that measures regional cerebral oxygenation in a non-invasive manner. Through the use of near infrared light, the difference between oxygenated and deoxygenated hemoglobin can be measured. By applying the Beer-Lamber law, a numeric result can be calculated. During a cardiac arrest, there is no stroke volume, no cardiac output and no cerebral perfusion. By using cerebral NIRS during out-of hospital cardiac arrest, low flow time and return of spontaneous circulation, this study wants to show the prognostic value of NIRS as extra monitoring.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pre-hospital cardiac arrest
Key inclusion criteria (1 listed)
- >16 year
Key exclusion criteria (1 listed)
- DNR code
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prognostic value
Time frame: 1 year
Prognostic value of cerebral oxygenation during CPR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Background: PubMed 23448653Meex I, De Deyne C, Dens J, Scheyltjens S, Lathouwers K, Boer W, Vundelinckx G, Heylen R, Jans F. Feasibility of absolute cerebral tissue oxygen saturation during cardiopulmonary resuscitation. Crit Care. 2013 Mar 1;17(2):R36. doi: 10.1186/cc12546.
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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.
Cornelia Genbrugge, MD principal investigator
Hasselt University
5 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 Arrest, run by Hasselt University at 5 sites in Belgium.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prognostic value (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01806844, which also lists 1 linked publication.
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 21 Apr 2016.