Clinical trial NCT02741375: Cerebral Oximetry As an Auxiliary Diagnostic Tool in the Diagnosis of Brain Death
Official title: Cerebral Oximetry As an Auxiliary Diagnostic Tool in the Diagnosis of Brain Death
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Death
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Potential BD patients.

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.

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.

Eligibility 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

Primary outcomes:
measure: Basal ScO2 (Cerebral oxygen saturation) (%)
timeFrame: Measured at the beginning of 6 hours cerebral oximetry monitoring
measure: End ScO2 (Cerebral oxygen saturation) (%)
timeFrame: Measured at the end of 6 hours cerebral oximetry monitoring
measure: Mean ScO2 (Cerebral oxygen saturation) (%)
timeFrame: Measured during 6 hours cerebral oximetry monitoring
measure: Min ScO2 (Cerebral oxygen saturation) (%)
timeFrame: Measured during 6 hours cerebral oximetry monitoring
measure: Max ScO2 (Cerebral oxygen saturation) (%)
timeFrame: Measured during 6 h cerebral oximetry monitoring
Secondary outcomes:
measure: Decrease in ScO2
timeFrame: Measured during 6 hours cerebral oximetry monitoring
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University Faculty of Medicine
Study officials:
References: