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ISRCTN
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ISRCTN91941687
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ClinicalTrials.gov identifier
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Public title
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Optic nerve sonography in the non-invasive assessment of severe brain injury
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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This study was designed to evaluate whether sonographic measurements of the optic nerve diameter correlate with synchronous, non-invasive and invasive measurements of the intracranial pressure in brain-injured adults.
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Ethics approval
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Institutional Ethics Committee of the General State Hospital of Athens, approved in 1999 (ref: 1999/02/ICUGG)
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Study design
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Prospective, randomised controlled study.
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Countries of recruitment
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Greece
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Disease/condition/study domain
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Severe brain injury
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Participants - inclusion criteria
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Intensive care patients who were hospitalized from October 2006 to August 2007
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Participants - exclusion criteria
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Patients with orbitofacial trauma or known disease of the optic nerve
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Anticipated start date
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01/10/2006
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Anticipated end date
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31/08/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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89
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Interventions
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All patients underwent non-invasive measurements of the intracranial pressure by transcranial Doppler sonography, and synchronous optic nerve diameter measurements by optic nerve sonography. Invasive measurements of the intracranial pressure by an intraparenchymal catheter were performed in 32 of the patients with severe brain injury.
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Primary outcome measure(s)
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The following were measured within the first 24 h of admission to the intensive care unit:
1. Optic nerve diameter
2. Intracranial pressure
3. Neuroimaging results
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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General State Hospital of Athens, Intensive Care Unit (Greece)
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Trial website
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Publications
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2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18477382
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Contact name
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Prof
Andreas
Karabinis
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Address
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Intensive Care Unit
General State Hospital of Athens
154 Mesogeion Avenue
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City/town
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Athens
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Zip/Postcode
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11527
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Country
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Greece
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Tel
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+30 21074 80188
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Fax
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+30 21074 80188
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Email
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soldatos@gmail.com
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Sponsor
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General State Hospital of Athens (Greece)
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Address
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Intensive Care Unit
154 Mesogeion Avenue
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City/town
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Athens
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Zip/Postcode
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11527
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Country
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Greece
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Tel
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+30 21074 80188
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Fax
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+30 21074 80188
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Email
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soldatos@gmail.com
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Date applied
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19/01/2008
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Last edited
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30/10/2008
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Date ISRCTN assigned
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14/02/2008
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