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Completed

NCT Number: NCT02741375

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

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.

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Key information

Conditions

Brain Death Brain Diseases Central Nervous System Diseases Coma Consciousness Disorders Death Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karadeniz Technical University Faculty of Medicine

Trabzon, 61080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  1. Decrease in ScO2

    Time frame: Measured during 6 hours cerebral oximetry monitoring

    Difference between basal ScO2 and end ScO2

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 18, 2016
Registry last updated
Apr 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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