Providing Sufficient Cerebral Oxygenation During CPRCPRNCT03062306
Chest Compression and Cerebral Oxygenation During Cardiopulmonary Resuscitation
An observational study of Providing Sufficient Cerebral Oxygenation During CPR, run by Nevsehir Public Hospital at 1 site in Turkey (Türkiye).
Trial summary
In recent years, monitorizations during Cardiopulmonary Resuscitation (CPR) are inadequate to show the sufficiency of cerebral oxygenation. During CPR, insufficient chest compressions have critical importance for neurological results and life quality after the return of spontaneous circulation (ROSC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Providing Sufficient Cerebral Oxygenation During CPR
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 May 2017to 31 Aug 2018
- 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: All patients undergoing cardiac arrest in intensive care unit
Who may be able to join
- 1. All patients undergoing cardiac arrest in intensive care unit
Who cannot join
- Head injury and intracranial bleeding
- Cerebral ischemic vascular event
- Pulmonary diseases that may affect blood-oxygen levels
- Below the age of 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Sufficient Cerebral Oxygenation be Provided in a Synchronized Manner With Chest Compression During Cardiopulmonary Resuscitation?
In recent years, monitorizations during Cardiopulmonary Resuscitation (CPR) are inadequate to show the sufficiency of cerebral oxygenation. During CPR, insufficient chest compressions have critical importance for neurological results and life quality after the return of spontaneous circulation (ROSC).
Read the detailed description
The Near-Infrared Spectroscopy (NIRS), which is used in measuring the cerebral tissue oxygenation is one of the latest technologies that allow the measurement of brain oxygen saturation. With this study, the issue of whether sufficient cerebral oxygenation is provided during CPR applied to patients that have Cardiac Arrest (CA) will be investigated, and the effect of CPR on the patient prognosis after ROSC will be examined. In this study, the aim is to investigate whether sufficient oxygenation is provided in synchronization with chest compressions during CPR; and to test the regional brain tissue saturation with rSO2 measurement, and the prognosis with Full Outline of UnResponsiveness (FOUR) Score in patients with ROSC.
- Keywords
- Cerebral Oxygenation, Cardiopulmonary Resuscitation, Chest Compression
What is being measured
The primary outcome is the main question the study is designed to answer.
The levels of regional brain tissue oxygen saturation (rSO2) providing with chest compressions during Cardiopulmonary Resuscitation (CPR)
The data will be obtained by using the Near Infrared Spectroscopy (NIRS) Device and will be recorded rSO2 measurement during the resuscitation of the Cardiac Arrest (CA) patients
Measured: About six month
Secondary outcomes (1)
Change from baseline in consciousness on Full Outline of UnResponsiveness (FOUR) Score at one week
The patient's consciousness will be evaluated by FOUR score in patients with ROSC
Measured: For a week after ROSC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start31 May 2017
- Primary completion31 Aug 2017
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Providing Sufficient Cerebral Oxygenation During CPRStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nevsehir Public Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Akif Yazar, Nevsehir Public Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062306
- Sponsor's protocol ID
- 2016/351
- Other IDs
- Erciyes University
- Acronym
- CPR
- Status last verified
- Feb 2019
- First submitted
- 16 Feb 2017
- Last updated
- 22 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Parnia S, Nasir A, Shah C, Patel R, Mani A, Richman P. A feasibility study evaluating the role of cerebral oximetry in predicting return of spontaneous circulation in cardiac arrest. Resuscitation. 2012 Aug;83(8):982-5. doi: 10.1016/j.resuscitation.2012.01.039. Epub 2012 Feb 6.
PubMed 22322284Kamarainen A, Sainio M, Olkkola KT, Huhtala H, Tenhunen J, Hoppu S. Quality controlled manual chest compressions and cerebral oxygenation during in-hospital cardiac arrest. Resuscitation. 2012 Jan;83(1):138-42. doi: 10.1016/j.resuscitation.2011.09.011. Epub 2011 Sep 28.
PubMed 21958930
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Sufficient Cerebral Oxygenation be Provided in a Synchronized Manner With Chest Compression During Cardiopulmonary Resuscitation?
- ClinicalTrials.gov ID
- NCT03062306
- Acronym / sponsor ID
- CPR / 2016/351
- Keywords
- Cerebral Oxygenation, Cardiopulmonary Resuscitation, Chest Compression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nevsehir Public HospitalOther government
- Study start
- 31 May 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 23 Feb 2017 (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.
In recent years, monitorizations during Cardiopulmonary Resuscitation (CPR) are inadequate to show the sufficiency of cerebral oxygenation. During CPR, insufficient chest compressions have critical importance for neurological results and life quality after the return of spontaneous circulation (ROSC).
Detailed description
The Near-Infrared Spectroscopy (NIRS), which is used in measuring the cerebral tissue oxygenation is one of the latest technologies that allow the measurement of brain oxygen saturation. With this study, the issue of whether sufficient cerebral oxygenation is provided during CPR applied to patients that have Cardiac Arrest (CA) will be investigated, and the effect of CPR on the patient prognosis after ROSC will be examined. In this study, the aim is to investigate whether sufficient oxygenation is provided in synchronization with chest compressions during CPR; and to test the regional brain tissue saturation with rSO2 measurement, and the prognosis with Full Outline of UnResponsiveness (FOUR) Score in patients with ROSC.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing cardiac arrest in intensive care unit
Key inclusion criteria (1 listed)
- 1. All patients undergoing cardiac arrest in intensive care unit
Key exclusion criteria (4 listed)
- Head injury and intracranial bleeding
- Cerebral ischemic vascular event
- Pulmonary diseases that may affect blood-oxygen levels
- Below the age of 18
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
The levels of regional brain tissue oxygen saturation (rSO2) providing with chest compressions during Cardiopulmonary Resuscitation (CPR)
Time frame: About six month
The data will be obtained by using the Near Infrared Spectroscopy (NIRS) Device and will be recorded rSO2 measurement during the resuscitation of the Cardiac Arrest (CA) patients
1 secondary outcome
Change from baseline in consciousness on Full Outline of UnResponsiveness (FOUR) Score at one week
Time frame: For a week after ROSC
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 22 Feb 2019.
- Background: PubMed 22322284Parnia S, Nasir A, Shah C, Patel R, Mani A, Richman P. A feasibility study evaluating the role of cerebral oximetry in predicting return of spontaneous circulation in cardiac arrest. Resuscitation. 2012 Aug;83(8):982-5. doi: 10.1016/j.resuscitation.2012.01.039. Epub 2012 Feb 6.
- Background: PubMed 21958930Kamarainen A, Sainio M, Olkkola KT, Huhtala H, Tenhunen J, Hoppu S. Quality controlled manual chest compressions and cerebral oxygenation during in-hospital cardiac arrest. Resuscitation. 2012 Jan;83(1):138-42. doi: 10.1016/j.resuscitation.2011.09.011. Epub 2011 Sep 28.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Providing Sufficient Cerebral Oxygenation During CPR, run by Nevsehir Public Hospital at 1 site in Turkey (Türkiye).
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 4 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 22 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 1 site in Turkey (Türkiye). 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?
The levels of regional brain tissue oxygen saturation (rSO2) providing with chest compressions during Cardiopulmonary Resuscitation (CPR) (time frame: About six month). 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 NCT03062306, which also lists 2 linked publications.
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 22 Feb 2019.