Optic nerve sonography in the non-invasive assessment of severe brain injury
| ISRCTN | ISRCTN91941687 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91941687 |
| Protocol serial number | N/A |
| Sponsor | General State Hospital of Athens (Greece) |
| Funder | General State Hospital of Athens, Intensive Care Unit (Greece) |
- Submission date
- 19/01/2008
- Registration date
- 14/02/2008
- Last edited
- 30/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Andreas Karabinis
Scientific
Scientific
Intensive Care Unit
General State Hospital of Athens
154 Mesogeion Avenue
Athens
11527
Greece
| Phone | +30 21074 80188 |
|---|---|
| soldatos@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, randomised controlled study. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Institutional Ethics Committee of the General State Hospital of Athens, approved in 1999 (ref: 1999/02/ICUGG) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
The following were measured within the first 24 h of admission to the intensive care unit: |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 31/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 89 |
| Key inclusion criteria | Intensive care patients who were hospitalized from October 2006 to August 2007 |
| Key exclusion criteria | Patients with orbitofacial trauma or known disease of the optic nerve |
| Date of first enrolment | 01/10/2006 |
| Date of final enrolment | 31/08/2007 |
Locations
Countries of recruitment
- Greece
Study participating centre
Intensive Care Unit
Athens
11527
Greece
11527
Greece
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2008 | Yes | No |
