Brain DeathNCT02741375
Cerebral Oximetry As an Auxiliary Diagnostic Tool in the Diagnosis of Brain Death
An observational study of Brain Death, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Death
- What is being tested?
- Somanetics 5100c (Invos oximeter cerebral/somatic Troy, MI, USA)
- Type of treatment
- Medical device
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential BD patients.
Who may be able to join
- 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
- Aged over 18 years
Who cannot join
- Cause of coma being undetermined
- Lack of confirmation of brain injury being diffuse and irreversible
- Central body temperature being lower than 32°C
- Presence of a picture of hypotensive shock
- Coma after drug effects and intoxications
- Presence of metabolic, electrolyte or acid-alkaline disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University Faculty of Medicine
Trabzon, 61080
About this study
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.
Read the 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.
- Conditions
- Brain Death
- Being tested
- Somanetics 5100c (Invos oximeter cerebral/somatic Troy, MI, USA)
- Medical subject headings
- Brain Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somanetics 5100c (Invos oximeter cerebral/somatic Troy, MI, USA)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Somanetics 5100c (Invos oximeter cerebral/somatic Troy, MI, USA) | |
| 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. Receives: Device: Somanetics 5100c (Invos oximeter cerebral/somatic Troy, MI, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Basal ScO2 (Cerebral oxygen saturation) (%)
Measured: Measured at the beginning of 6 hours cerebral oximetry monitoring
End ScO2 (Cerebral oxygen saturation) (%)
Measured: Measured at the end of 6 hours cerebral oximetry monitoring
Mean ScO2 (Cerebral oxygen saturation) (%)
Measured: Measured during 6 hours cerebral oximetry monitoring
Min ScO2 (Cerebral oxygen saturation) (%)
Measured: Measured during 6 hours cerebral oximetry monitoring
Max ScO2 (Cerebral oxygen saturation) (%)
Measured: Measured during 6 h cerebral oximetry monitoring
Secondary outcomes (1)
Decrease in ScO2
Difference between basal ScO2 and end ScO2
Measured: Measured during 6 hours cerebral oximetry monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startJan 2014
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DeathStudies 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suleyman Turedi, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741375
- Sponsor's protocol ID
- 2014/05
- Status last verified
- Apr 2016
- First submitted
- 7 Apr 2016
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oximetry As an Auxiliary Diagnostic Tool in the Diagnosis of Brain Death
- ClinicalTrials.gov ID
- NCT02741375
- Acronym / sponsor ID
- 2014/05
- Conditions
- Brain Death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 18 Apr 2016 (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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain Death Group (BD group) | – | Device: Somanetics 5100c (Invos oximeter cerebral/somatic Troy, MI, USA)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. |
| Non-Brain Death Group (Non BD group) | – | Device: Somanetics 5100c (Invos oximeter cerebral/somatic Troy, MI, USA)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential BD patients.
Key inclusion criteria (2 listed)
- 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
- Aged over 18 years
Key exclusion criteria (6 listed)
- Cause of coma being undetermined
- Lack of confirmation of brain injury being diffuse and irreversible
- Central body temperature being lower than 32°C
- Presence of a picture of hypotensive shock
- Coma after drug effects and intoxications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Brain Death Group (BD group), Non-Brain Death Group (Non BD group) |
Primary outcome
Basal ScO2 (Cerebral oxygen saturation) (%)
Time frame: Measured at the beginning of 6 hours cerebral oximetry monitoring
End ScO2 (Cerebral oxygen saturation) (%)
Time frame: Measured at the end of 6 hours cerebral oximetry monitoring
Mean ScO2 (Cerebral oxygen saturation) (%)
Time frame: Measured during 6 hours cerebral oximetry monitoring
Min ScO2 (Cerebral oxygen saturation) (%)
Time frame: Measured during 6 hours cerebral oximetry monitoring
Max ScO2 (Cerebral oxygen saturation) (%)
Time frame: Measured during 6 h cerebral oximetry monitoring
1 secondary outcome
Decrease in ScO2
Time frame: Measured during 6 hours cerebral oximetry monitoring
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 18 Apr 2016.
- Individual participant dataSharing planned: Yes
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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.
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 Brain Death, run by Karadeniz Technical University 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 2 inclusion and 6 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 18 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 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?
Basal ScO2 (Cerebral oxygen saturation) (%) (time frame: Measured at the beginning of 6 hours cerebral oximetry monitoring). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2016.