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

NCT02741375 | Completed

• 1 other identifier: 2014/05
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Death

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Decrease in ScO2

  Measured during 6 hours cerebral oximetry monitoring

Study Arms (2)

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)

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)

Interventions

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.

Brain Death Group (BD group); Non-Brain Death Group (Non BD group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Potential BD patients.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical University Faculty of Medicine

Trabzon, 61080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Brain Death

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof., M.D.

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: April 18, 2016
• Study Start: January 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: April 18, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)