Transcranial doppler sonography with a transorbital approach as a confirmatory test in the diagnosis of brain death

ISRCTN	ISRCTN49093383
DOI	https://doi.org/10.1186/ISRCTN49093383
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Andreas Karabinis
Scientific

154 Mesogeion Ave
Athens
11527
Greece

Phone	+30 21 0748 0188
Email	echolabicu@gmail.com

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Scientific title
Study objectives	This study was designed to evaluate whether the routine addition of the transorbital doppler examination of the carotid siphon in patients suspected of brain death improves the efficiency of the transcranial doppler examination protocol.
Ethics approval(s)	The study was approved by the Institutional Ethics Committee of the General State Hospital of Athens in 2005 (ref: ICUTCD2005/2).
Health condition(s) or problem(s) studied	Brain death
Intervention	All patients underwent cerebral angiography, transcranial doppler examination of the basilar, anterior and middle cerebral arteries bilaterally. In addition, the patients in the intervention group were assessed by transorbital doppler of the carotid siphons bilaterally.
Intervention type	Other
Primary outcome measure	Blood flow patterns measured by transcranial doppler sonography with a suboccipital, transtemporal and transorbital approach.
Secondary outcome measures	Efficacy of the transorbital approach in the diagnosis of brain death with transcranial doppler sonography.
Overall study start date	01/10/2005
Completion date	31/07/2008

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	79
Key inclusion criteria	Brain dead patients of the intensive care unit (both males and females, aged greater than 16 years) who were hospitalised from October 2005 to July 2008.
Key exclusion criteria	1. Patients with an episode of hypoxia or hypotension during the angiographic or transcranial doppler examinations 2. Patients with no flow at the initial transcranial doppler examination in any approach
Date of first enrolment	01/10/2005
Date of final enrolment	31/07/2008

154 Mesogeion Ave

Athens
11527
Greece

Athens General Hospital "G. Gennimatas" (Greece)
Hospital/treatment centre

ICU Department
154 Mesogeion Ave
Athens
11527
Greece

Hospital/treatment centre

Athens General Hospital "G. Gennimatas" (Greece) - Intensive Care Unit (ICU) Department

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan