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

Completed

• Conditions: Brain Death
• Interventions: Device: Somanetics 5100c (Invos oximeter cerebral/somatic Troy, MI, USA)

• Registration Number: NCT02741375
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-01
• Primary Completion: 2015-06
• Study Completion: 2015-07
• Status Verified: 2016-04
• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-04-15
• Last Update Submitted: 2016-04-15
• Study First Posted: 2016-04-18
• Last Update Posted: 2016-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Brain Death Group (BD group)	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)	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.

Primary Outcome Measures

Name	Time	Method
Basal ScO2 (Cerebral oxygen saturation) (%)	Measured at the beginning of 6 hours cerebral oximetry monitoring
End ScO2 (Cerebral oxygen saturation) (%)	Measured at the end of 6 hours cerebral oximetry monitoring
Mean ScO2 (Cerebral oxygen saturation) (%)	Measured during 6 hours cerebral oximetry monitoring
Min ScO2 (Cerebral oxygen saturation) (%)	Measured during 6 hours cerebral oximetry monitoring
Max ScO2 (Cerebral oxygen saturation) (%)	Measured during 6 h cerebral oximetry monitoring

Secondary Outcome Measures

Name	Time	Method
Decrease in ScO2	Measured during 6 hours cerebral oximetry monitoring	Difference between basal ScO2 and end ScO2

Trial Locations

Locations (1)

Karadeniz Technical University Faculty of Medicine; 🇹🇷 Trabzon, Turkey