Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cerebral Oximetry As an Auxiliary Diagnostic Tool in the Diagnosis of Brain Death

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02741375
Recruitment Status : Completed
First Posted : April 18, 2016
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):
Suleyman Turedi, Karadeniz Technical University

Brief Summary:

Aim: To investigate the efficacy of cerebral oximetry (CO) as an auxiliary diagnostic tool in confirming brain death (BD).

Materials and Methods: This observational and interventional study was performed on patients with suspected BD in emergency departments and intensive care units. CO monitoring was performed for at least 6 h, and cerebral tissue oxygen saturation (ScO2) was recorded. Basal ScO2 values (basal ScO2), ScO2 values after 6 h (end ScO2), mean ScO2 values during monitoring (mean ScO2), and minimum (min ScO2) and maximum (max ScO2) ScO2 values observed during monitoring were recorded for all patients. Patients with diagnosis of BD confirmed by the organ transplantation and brain death committee were enrolled as the BD group and other patients as the non-BD group, and cerebral oxygen parameters were compared.


Condition or disease Intervention/treatment
Brain Death Device: Somanetics 5100c (Invos oximeter cerebral/somatic Troy, MI, USA)

Detailed Description:

Brain death (BD) means the irreversible loss of all brain and brain stem functions and physiopathologically the cessation of intracranial circulation. BD is a clinical diagnosis that can be made with various clinical tests. However, in order for BD to be definitely established, clinical tests performed initially need to be repeated after 24 h or to be confirmed by corroboratory tests. In addition, the obligation to confirm BD using corroboratory tests varies in current guidelines from country to country but has been eliminated except for certain specific circumstances. However, considering the adverse effects on patients awaiting donor and organ donations of the time lapse between initial and repeat tests in order to confirm BD, more rapid confirmation of definite BD is commonly made using corroboratory tests.

This study was planned with the hypothesis that this non-invasive technique using NIRS technology can be an auxiliary tool in the diagnosis of BD.

This study was performed with patients with suspected BD in emergency departments and intensive care units and was intended to evaluate the effectiveness of cerebral oximetry as an auxiliary diagnostic tool in patients with suspected BD.


Layout table for study information
Study Type : Observational
Actual Enrollment : 78 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Cerebral Oximetry As an Auxiliary Diagnostic Tool in the Diagnosis of Brain Death
Study Start Date : January 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : July 2015

Group/Cohort Intervention/treatment
Brain Death Group (BD group)
Patients assessed as brain-dead at the first clinical evaluation by the OTBD committee were definitively diagnosed with BD through repeat clinical evaluation after 24 h or through CT angiography as a corroboratory test. Patients regarded as definitely brain-dead on the basis of this evaluation were classified as the BD group.
Device: Somanetics 5100c (Invos oximeter cerebral/somatic Troy, MI, USA)
All patients underwent at least 6-h NIRS monitoring using a Somanetics 5100c (Invos oximeter cerebral/somatic Troy, MI, USA) cerebral oximeter in order to determined cerebral oximetry changes.

Non-Brain Death Group (Non BD group)
Patients assessed as brain-dead at the first clinical evaluation by the OTBD committee were definitively diagnosed with BD through repeat clinical evaluation after 24 h or through CT angiography as a corroboratory test. Patients regarded as definitely not brain-dead on the basis of this evaluation were classified as the non-BD group.
Device: Somanetics 5100c (Invos oximeter cerebral/somatic Troy, MI, USA)
All patients underwent at least 6-h NIRS monitoring using a Somanetics 5100c (Invos oximeter cerebral/somatic Troy, MI, USA) cerebral oximeter in order to determined cerebral oximetry changes.




Primary Outcome Measures :
  1. Basal ScO2 (Cerebral oxygen saturation) (%) [ Time Frame: Measured at the beginning of 6 hours cerebral oximetry monitoring ]
  2. End ScO2 (Cerebral oxygen saturation) (%) [ Time Frame: Measured at the end of 6 hours cerebral oximetry monitoring ]
  3. Mean ScO2 (Cerebral oxygen saturation) (%) [ Time Frame: Measured during 6 hours cerebral oximetry monitoring ]
  4. Min ScO2 (Cerebral oxygen saturation) (%) [ Time Frame: Measured during 6 hours cerebral oximetry monitoring ]
  5. Max ScO2 (Cerebral oxygen saturation) (%) [ Time Frame: Measured during 6 h cerebral oximetry monitoring ]

Secondary Outcome Measures :
  1. Decrease in ScO2 [ Time Frame: Measured during 6 hours cerebral oximetry monitoring ]
    Difference between basal ScO2 and end ScO2



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Potential BD patients.
Criteria

Inclusion Criteria:

  1. All patients monitored and treated in the emergency department of intensive care units with a GCS score of 3 and evaluated as brain-dead at consultation with the Organ Transplantation Brain Death Committee on suspicion of BD
  2. Aged over 18 years

Exclusion Criteria:

  1. Cause of coma being undetermined
  2. Lack of confirmation of brain injury being diffuse and irreversible
  3. Central body temperature being lower than 32°C
  4. Presence of a picture of hypotensive shock
  5. Coma after drug effects and intoxications
  6. Presence of metabolic, electrolyte or acid-alkaline disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741375


Locations
Layout table for location information
Turkey
Karadeniz Technical University Faculty of Medicine
Trabzon, Turkey, 61080
Sponsors and Collaborators
Karadeniz Technical University

Layout table for additonal information
Responsible Party: Suleyman Turedi, Assoc. Prof., M.D., Karadeniz Technical University
ClinicalTrials.gov Identifier: NCT02741375     History of Changes
Other Study ID Numbers: 2014/05
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Layout table for MeSH terms
Death
Brain Death
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations