- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03062306
Chest Compression and Cerebral Oxygenation During Cardiopulmonary Resuscitation (CPR)
February 20, 2019 updated by: Mehmet Akif Yazar, Nevsehir Public Hospital
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).
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nevsehir, Turkey, 50100
- Mehmet Akif YAZAR
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All patients undergoing cardiac arrest in intensive care unit
Description
Inclusion Criteria:
1. All patients undergoing cardiac arrest in intensive care unit
Exclusion Criteria:
- Head injury and intracranial bleeding
- Cerebral ischemic vascular event
- Pulmonary diseases that may affect blood-oxygen levels
- Below the age of 18
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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About six month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in consciousness on Full Outline of UnResponsiveness (FOUR) Score at one week
Time Frame: For a week after ROSC
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The patient's consciousness will be evaluated by FOUR score in patients with ROSC
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For a week after ROSC
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Kamarainen 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 31, 2017
Primary Completion (Actual)
August 31, 2017
Study Completion (Actual)
August 31, 2018
Study Registration Dates
First Submitted
February 16, 2017
First Submitted That Met QC Criteria
February 20, 2017
First Posted (Actual)
February 23, 2017
Study Record Updates
Last Update Posted (Actual)
February 22, 2019
Last Update Submitted That Met QC Criteria
February 20, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 2016/351
- Erciyes University (Clinical Research Ethics Committee)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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