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

Brain Death Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02741375
• Other study ID #: 2014/05
• Status: Completed
• Phase: Phase 4
• First received: April 7, 2016
• Last updated: April 15, 2016
• Start date: January 2014
• Est. completion date: July 2015

Study information

• Verified date: April 2016
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Karadeniz Technical University Medical Faculty Clinical Research Ethical Committee
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Death
• Death

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Turkey	Karadeniz Technical University Faculty of Medicine	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Basal ScO2 (Cerebral oxygen saturation) (%)		Measured at the beginning of 6 hours cerebral oximetry monitoring	No
Primary	End ScO2 (Cerebral oxygen saturation) (%)		Measured at the end of 6 hours cerebral oximetry monitoring	No
Primary	Mean ScO2 (Cerebral oxygen saturation) (%)		Measured during 6 hours cerebral oximetry monitoring	No
Primary	Min ScO2 (Cerebral oxygen saturation) (%)		Measured during 6 hours cerebral oximetry monitoring	No
Primary	Max ScO2 (Cerebral oxygen saturation) (%)		Measured during 6 h cerebral oximetry monitoring	No
Secondary	Decrease in ScO2	Difference between basal ScO2 and end ScO2	Measured during 6 hours cerebral oximetry monitoring	No