Condition category
Injury, Occupational Diseases, Poisoning
Date applied
19/01/2008
Date assigned
14/02/2008
Last edited
30/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Andreas Karabinis

ORCID ID

Contact details

Intensive Care Unit
General State Hospital of Athens
154 Mesogeion Avenue
Athens
11527
Greece
+30 21074 80188
soldatos@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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.

Ethics approval

Institutional Ethics Committee of the General State Hospital of Athens, approved in 1999 (ref: 1999/02/ICUGG)

Study design

Prospective, randomised controlled study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Diagnostic

Patient information sheet

Condition

Severe brain injury

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/10/2006

Overall trial end date

31/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Intensive care patients who were hospitalized from October 2006 to August 2007

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

89

Participant exclusion criteria

Patients with orbitofacial trauma or known disease of the optic nerve

Recruitment start date

01/10/2006

Recruitment end date

31/08/2007

Locations

Countries of recruitment

Greece

Trial participating centre

Intensive Care Unit
Athens
11527
Greece

Sponsor information

Organisation

General State Hospital of Athens (Greece)

Sponsor details

Intensive Care Unit
154 Mesogeion Avenue
Athens
11527
Greece
+30 21074 80188
soldatos@gmail.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

General State Hospital of Athens, Intensive Care Unit (Greece)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18477382

Publication citations

  1. Results

    Soldatos T, Karakitsos D, Chatzimichail K, Papathanasiou M, Gouliamos A, Karabinis A, Optic nerve sonography in the diagnostic evaluation of adult brain injury., Crit Care, 2008, 12, 3, R67, doi: 10.1186/cc6897.

Additional files

Editorial Notes