- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03024021
Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia
The Effect of Cerebral Oxymetry in Determining Neurological Outcome in Patients Treated With Therapeutic Hypothermia
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Konak
-
Izmir, Konak, Turkey, 35110
- Tepecik Research and Training Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients at least 18 years old
- Patients undergoing therapeutic hypothermia
Exclusion Criteria:
- Patients under 18 years
- Patients unsuitable for therapeutic hypothermia
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure of cerebral oximetry
Time Frame: 8 times during the first 48 hours of hospitalization
|
During the first 48 hours of hospitalization, we will collect the cerebral oximetry values in the two cerebral.
hemispheres.
|
8 times during the first 48 hours of hospitalization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome according with CPC score
Time Frame: Participants will be followed for 8 times during the first 48 hours of hospitalization, the third day, fourth day and fifth day and the duration of hospital stay, an expected average of 2-4 weeks and a 12 month follow up will be performed
|
The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome according to the CPC score. CPC 1: Conscious and alert with normal function or only slight disability CPC 2: Conscious and alert with moderate disability CPC 3: Conscious with severe disability CPC 4: Comatose or persistent vegetative state CPC 5: death. CPC will be evaluated at the time of admission to intensive care unit and day 21.CPC score (CPC = 1 become good score - 2 and bad become CPC = 3-5). |
Participants will be followed for 8 times during the first 48 hours of hospitalization, the third day, fourth day and fifth day and the duration of hospital stay, an expected average of 2-4 weeks and a 12 month follow up will be performed
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome according with Four score
Time Frame: Participants will be followed for 8 times during the first 48 hours of hospitalization, the third day, fourth day and fifth day and the duration of hospital stay, an expected average of 2-4 weeks and a 12 month follow up will be performed
|
The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome according to the Fourscore (Full Outline of UnResponsiveness):It evaluates four functional categories: eye response, motor response, brainstem reflexes, and respiration pattern (including mechanical ventilation).
All the four categories are scored from 0 to 4 points, with 4 representing normal, and 0 indicating no function.
|
Participants will be followed for 8 times during the first 48 hours of hospitalization, the third day, fourth day and fifth day and the duration of hospital stay, an expected average of 2-4 weeks and a 12 month follow up will be performed
|
Collaborators and Investigators
Investigators
- Study Director: Aykut Saritas, Tepecik Research and Training Hospital
- Study Chair: Burcu Acar Cinleti, suat seren research and training hospital
- Study Chair: Ciler Zincircioglu, Tepecik Research and Training Hospital
- Study Chair: İsil Kose, Tepecik Research and Training Hospital
- Study Chair: Ugur Uzun, Tepecik Research and Training Hospital
- Study Chair: Nimet Senoglu, Tepecik Research and Training Hospital
Publications and helpful links
General Publications
- Storm C, Leithner C, Krannich A, Wutzler A, Ploner CJ, Trenkmann L, von Rheinbarben S, Schroeder T, Luckenbach F, Nee J. Regional cerebral oxygen saturation after cardiac arrest in 60 patients--a prospective outcome study. Resuscitation. 2014 Aug;85(8):1037-41. doi: 10.1016/j.resuscitation.2014.04.021. Epub 2014 Apr 30.
- Genbrugge C, Eertmans W, Meex I, Van Kerrebroeck M, Daems N, Creemers A, Jans F, Boer W, Dens J, De Deyne C. What is the value of regional cerebral saturation in post-cardiac arrest patients? A prospective observational study. Crit Care. 2016 Oct 13;20(1):327. doi: 10.1186/s13054-016-1509-9.
- Nishiyama K, Ito N, Orita T, Hayashida K, Arimoto H, Beppu S, Abe M, Unoki T, Endo T, Murai A, Hatada T, Yamada N, Mizobuchi M, Himeno H, Okuchi K, Yasuda H, Mochizuki T, Shiga K, Kikuchi M, Tsujimura Y, Hatanaka T, Nagao K; J-POP Registry Investigators. Regional cerebral oxygen saturation monitoring for predicting interventional outcomes in patients following out-of-hospital cardiac arrest of presumed cardiac cause: A prospective, observational, multicentre study. Resuscitation. 2015 Nov;96:135-41. doi: 10.1016/j.resuscitation.2015.07.049. Epub 2015 Aug 17.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29/3
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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