Elevated Intracranial PressureNCT03691025
Association of the Optic Nerve Sheath Diameter With Eyeball Transverse Diameter in Robot-assisted Prostatectomy
An observational study of Elevated Intracranial Pressure and Optic Nerve Sheath Diameter, run by Hacettepe University.
Trial summary
Robot-assisted laparoscopic radical prostatectomy (RALRP) is becoming a popular procedure due to its unique advantages. Despite these advantages, pneumoperitoneum and steep trendelenburg position are associated with hemodynamic instability and elevated intracranial pressures (ICP). Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Elevated Intracranial Pressure, Optic Nerve Sheath Diameter, ONSD /ETD Ratio
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2018to 1 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- Adult, Older adult
Study population: patients referred to Hacettepe University Department of Urology
Who may be able to join
- 19-75 years patients undergoing RALP
Who cannot join
- a history of corneal surgery, open-angle or closed-angle glaucoma
- intraocular surgery
- history of elevated ICPs
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ultrasonographic Measurement of the Optic Nerve Sheath Diameter and Its Association With Eyeball Transverse Diameter in Robot-assisted Laparoscopic Radical Prostatectomy
Robot-assisted laparoscopic radical prostatectomy (RALRP) is becoming a popular procedure due to its unique advantages.
Despite these advantages, pneumoperitoneum and steep trendelenburg position are associated with hemodynamic instability and elevated intracranial pressures (ICP).
Read more
Ultrasonographic measurement of optic nerve sheath diameter (ONSD) is an indirect but also a generally accepted reliable and noninvasive measurement of elevated ICP. However, optimal cut-off values are highly inconsistent due to multiple factors (gender, height, weight). To eliminate the effects of these factors on the results; a ratio should be established in patients known to have elevated ICPs.
In a recent study ONSD/ eyeball transverse diameter(ETD) in healthy volunteers in a specific population was established.
60 patients without any history of ICP undergoing RALRP will be enrolled to the study. Ultrasonographic measurement of ONSD and ETD will be performed 10 minutes after induction of general anesthesia, 10 minutes after CO2 pneumoperitoneum with trendelenburg positioning and measurements will be repeated hourly and at last after returning to supine position without CO2 pneumoperitoneum at the end of the procedure.
Hemodynamic variables and BIS values on this specific times will be recorded and an arterial sample will be obtained.
- Keywords
- robot assisted laparoscopic prostatectomy, optic nerve sheath diameter
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RALPD | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of the Optic Nerve Sheath Diameter With Eyeball Transverse Diameter in Robot-assisted Prostatectomy
To determine a cut off value for ratio of ONSD to ETD in a group known to have elevated ICPs
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start15 Oct 2018 (estimated)
- Primary completion15 Feb 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elevated Intracranial PressureStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Başak Akça, Hacettepe University
- Investigators
- Başak Akça, Principal investigator, Hacettepe University Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691025
- Sponsor's protocol ID
- hacetteperobotprostat
- Status last verified
- Sep 2018
- First submitted
- 28 Sep 2018
- Last updated
- 2 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim DH, Jun JS, Kim R. Ultrasonographic measurement of the optic nerve sheath diameter and its association with eyeball transverse diameter in 585 healthy volunteers. Sci Rep. 2017 Nov 21;7(1):15906. doi: 10.1038/s41598-017-16173-z.
PubMed 29162911
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Measurement of the Optic Nerve Sheath Diameter and Its Association With Eyeball Transverse Diameter in Robot-assisted Laparoscopic Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT03691025
- Acronym / sponsor ID
- hacetteperobotprostat
- Keywords
- robot assisted laparoscopic prostatectomy, optic nerve sheath diameter
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Oct 2018 (estimated)
- Primary completion
- 15 Feb 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Robot-assisted laparoscopic radical prostatectomy (RALRP) is becoming a popular procedure due to its unique advantages.
Despite these advantages, pneumoperitoneum and steep trendelenburg position are associated with hemodynamic instability and elevated intracranial pressures (ICP).
Ultrasonographic measurement of optic nerve sheath diameter (ONSD) is an indirect but also a generally accepted reliable and noninvasive measurement of elevated ICP. However, optimal cut-off values are highly inconsistent due to multiple factors (gender, height, weight). To eliminate the effects of these factors on the results; a ratio should be established in patients known to have elevated ICPs.
In a recent study ONSD/ eyeball transverse diameter(ETD) in healthy volunteers in a specific population was established.
60 patients without any history of ICP undergoing RALRP will be enrolled to the study. Ultrasonographic measurement of ONSD and ETD will be performed 10 minutes after induction of general anesthesia, 10 minutes after CO2 pneumoperitoneum with trendelenburg positioning and measurements will be repeated hourly and at last after returning to supine position without CO2 pneumoperitoneum at the end of the procedure.
Hemodynamic variables and BIS values on this specific times will be recorded and an arterial sample will be obtained.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RALPD | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- patients referred to Hacettepe University Department of Urology
Key inclusion criteria (1 listed)
- 19-75 years patients undergoing RALP
Key exclusion criteria (3 listed)
- a history of corneal surgery, open-angle or closed-angle glaucoma
- intraocular surgery
- history of elevated ICPs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association of the Optic Nerve Sheath Diameter With Eyeball Transverse Diameter in Robot-assisted Prostatectomy
Time frame: 6 months
To determine a cut off value for ratio of ONSD to ETD in a group known to have elevated ICPs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Results publication: PubMed 29162911Kim DH, Jun JS, Kim R. Ultrasonographic measurement of the optic nerve sheath diameter and its association with eyeball transverse diameter in 585 healthy volunteers. Sci Rep. 2017 Nov 21;7(1):15906. doi: 10.1038/s41598-017-16173-z.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Başak Akça principal investigator
Hacettepe University Department of Anesthesiology and Reanimation
Questions about this trial
What is this clinical trial studying?
An observational study of Elevated Intracranial Pressure and Optic Nerve Sheath Diameter, run by Hacettepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Başak Akça (00905322275451, drbasakakca@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of the Optic Nerve Sheath Diameter With Eyeball Transverse Diameter in Robot-assisted Prostatectomy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03691025, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.