Optic Nerve Sheath DiameterNCT05185908
The Effects of Lateral 45° Downward Position on the Optic Nerve Sheath Diameter
An observational study of Optic Nerve Sheath Diameter, run by Istanbul University.
Trial summary
Trendelenburg position and carbon dioxide (CO2) pneumoperitoneum are in association with increased intracranial pressure (ICP) reflected by the optic nerve sheath diameter (ONSD). Measurement of ONSD by ultrasound (US) guidance can be used in the diagnosis of ICP. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Optic Nerve Sheath Diameter
- What is being tested?
- Measurement of the optic nerve sheath diameter by ultrasound-guidance.
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 1 Jan 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Twenty-six patients who have undergone laparoscopic transperitoneal nephrectomy in the period of December 2016 and February 2017 were included in this study.
Who may be able to join
- All patients older than 18 years who have undergone laparoscopic transperitoneal nephrectomy.
Who cannot join
- Those who have neurological and cerebrovascular disease.
About this study
Official title: The Effects of Lateral 45° Downward Position and Carbon Dioxide Pneumoperitoneum on the Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Transperitoneal Nephrectomies: A Prospective Observational Study
Trendelenburg position and carbon dioxide (CO2) pneumoperitoneum are in association with increased intracranial pressure (ICP) reflected by the optic nerve sheath diameter (ONSD). Measurement of ONSD by ultrasound (US) guidance can be used in the diagnosis of ICP. The investigators interrogated the effects of lateral 45° downward position and CO2 insufflation on ONSD in patients undergoing laparoscopic transperitoneal nephrectomy.
Read the detailed description
Transperitoneal laparoscopic nephrectomy is a popular and increasingly used alternative to the laparoscopic retroperitoneal approach because of benefits such as minimal invasion, the transperitoneal path provides a larger working space and familiar anatomic landmarks. This technique requires a steep (35° to 45°) lateral downward (SLD) position and a CO2 pneumoperitoneum. SLD may lead to pathophysiological changes such as pulmonary dysfunction with the formation of atelectasis and increasing airway pressure as well as ocular complications. These are firstly reported 2 patients with bilateral ischaemic optic neuropathy (ION) after a da Vinci robotic-assisted procedure. SLD has raised concerns that prolonged elevation of venous pressure in the head may increase the risk of developing ION. However, a few investigations have yet been made into intraoperative changes in intraocular pressure (IOP) and optic nerve sheath diameter (ONSD) - correlating with intracranial pressure (ICP) - and their adverse ocular effects. The operative conditions get better the steeper the positioning, providing an excellent intraabdominal view and probably less bleeding. The hypothesis of the study is that patients placed in SLD for several hours have a high risk for ocular changes and peri- and postoperative complications. The aim of this study was to investigate the influence of capnoperitoneum and permanent 45° SLD on IOP and ONSD in patients undergoing laparoscopic transperitoneal nephrectomy. The investigators also analyzed the hemodynamic and respiratory parameters, duration of surgery during laparoscopic nephrectomy. Perioperative and postoperative complications were also recorded.
- Conditions
- Optic Nerve Sheath Diameter
- Being tested
- Measurement of the optic nerve sheath diameter by ultrasound-guidance.
- Keywords
- Carbondioxide pneumoperitoneum, Optic nerve, Nephrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of the optic nerve sheath diameter by ultrasound-guidance.Procedure or surgery
Measurement of the optic nerve sheath diameter (ONSD) by ultrasound guidance can be used in the diagnosis of increased ICP. The investigators interrogated the effects of lateral 45° downward position and CO2 insufflation on ONSD in patients undergoing laparoscopic transperitoneal nephrectomy.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | The patients undergoing laparoscopic transperitoneal nephrectomy. Receives: Procedure: Measurement of the optic nerve sheath diameter by ultrasound-guidance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
optic nerve sheath diameter
Measurement of optic nerve sheath diameter by ultrasound (US) guidance can be used in the diagnosis of increased intracranial pressure (ICP).
Measured: up to 24 hours
Secondary outcomes (2)
Respiratory parameters
Peak inspiratory pressure
Measured: up to 24 hours
Hemodynamic parameters
Mean arterial pressure
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Dec 2016
- Primary completion2 Mar 2017
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Optic Nerve Sheath DiameterStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Savran Karadeniz, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185908
- Sponsor's protocol ID
- OpticNerveSheathIU
- Status last verified
- Dec 2021
- First submitted
- 5 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Verdonck P, Kalmar AF, Suy K, Geeraerts T, Vercauteren M, Mottrie A, De Wolf AM, Hendrickx JF. Optic nerve sheath diameter remains constant during robot assisted laparoscopic radical prostatectomy. PLoS One. 2014 Nov 4;9(11):e111916. doi: 10.1371/journal.pone.0111916. eCollection 2014.
PubMed 25369152Chin JH, Seo H, Lee EH, Lee J, Hong JH, Hwang JH, Kim YK. Sonographic optic nerve sheath diameter as a surrogate measure for intracranial pressure in anesthetized patients in the Trendelenburg position. BMC Anesthesiol. 2015 Mar 31;15:43. doi: 10.1186/s12871-015-0025-9. eCollection 2015.
PubMed 25861241Blecha S, Harth M, Schlachetzki F, Zeman F, Blecha C, Flora P, Burger M, Denzinger S, Graf BM, Helbig H, Pawlik MT. Changes in intraocular pressure and optic nerve sheath diameter in patients undergoing robotic-assisted laparoscopic prostatectomy in steep 45 degrees Trendelenburg position. BMC Anesthesiol. 2017 Mar 11;17(1):40. doi: 10.1186/s12871-017-0333-3.
PubMed 28284189Atasever AG, Salviz EA, Senturk Ciftci H, Bingul ES, Sivrikoz N, Erdem S, Savran Karadeniz M. The Effects of Lateral 45 degrees Head-Down Position and Carbon Dioxide Pneumoperitoneum on the Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Transperitoneal Nephrectomies: A Prospective Observational Study. J Laparoendosc Adv Surg Tech A. 2023 Feb;33(2):171-176. doi: 10.1089/lap.2022.0344. Epub 2022 Aug 25.
PubMed 36036829
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lateral 45° Downward Position and Carbon Dioxide Pneumoperitoneum on the Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Transperitoneal Nephrectomies: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05185908
- Acronym / sponsor ID
- OpticNerveSheathIU
- Conditions
- Optic Nerve Sheath Diameter
- Keywords
- Carbondioxide pneumoperitoneum, Optic nerve, Nephrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 2 Mar 2017 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 11 Jan 2022 (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.
Trendelenburg position and carbon dioxide (CO2) pneumoperitoneum are in association with increased intracranial pressure (ICP) reflected by the optic nerve sheath diameter (ONSD). Measurement of ONSD by ultrasound (US) guidance can be used in the diagnosis of ICP. The investigators interrogated the effects of lateral 45° downward position and CO2 insufflation on ONSD in patients undergoing laparoscopic transperitoneal nephrectomy.
Detailed description
Transperitoneal laparoscopic nephrectomy is a popular and increasingly used alternative to the laparoscopic retroperitoneal approach because of benefits such as minimal invasion, the transperitoneal path provides a larger working space and familiar anatomic landmarks. This technique requires a steep (35° to 45°) lateral downward (SLD) position and a CO2 pneumoperitoneum. SLD may lead to pathophysiological changes such as pulmonary dysfunction with the formation of atelectasis and increasing airway pressure as well as ocular complications. These are firstly reported 2 patients with bilateral ischaemic optic neuropathy (ION) after a da Vinci robotic-assisted procedure. SLD has raised concerns that prolonged elevation of venous pressure in the head may increase the risk of developing ION. However, a few investigations have yet been made into intraoperative changes in intraocular pressure (IOP) and optic nerve sheath diameter (ONSD) - correlating with intracranial pressure (ICP) - and their adverse ocular effects. The operative conditions get better the steeper the positioning, providing an excellent intraabdominal view and probably less bleeding. The hypothesis of the study is that patients placed in SLD for several hours have a high risk for ocular changes and peri- and postoperative complications. The aim of this study was to investigate the influence of capnoperitoneum and permanent 45° SLD on IOP and ONSD in patients undergoing laparoscopic transperitoneal nephrectomy. The investigators also analyzed the hemodynamic and respiratory parameters, duration of surgery during laparoscopic nephrectomy. Perioperative and postoperative complications were also recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Measurement of the optic nerve sheath diameter by ultrasound-guidance.The patients undergoing laparoscopic transperitoneal nephrectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty-six patients who have undergone laparoscopic transperitoneal nephrectomy in the period of December 2016 and February 2017 were included in this study.
Key inclusion criteria (1 listed)
- All patients older than 18 years who have undergone laparoscopic transperitoneal nephrectomy.
Key exclusion criteria (1 listed)
- Those who have neurological and cerebrovascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of the optic nerve sheath diameter by ultrasound-guidance.Measurement of the optic nerve sheath diameter (ONSD) by ultrasound guidance can be used in the diagnosis of increased ICP. The investigators interrogated the effects of lateral 45° downward position and CO2 insufflation on ONSD in patients undergoing laparoscopic transperitoneal nephrectomy. | Procedure or surgery | Group 1 |
Primary outcome
optic nerve sheath diameter
Time frame: up to 24 hours
Measurement of optic nerve sheath diameter by ultrasound (US) guidance can be used in the diagnosis of increased intracranial pressure (ICP).
2 secondary outcomes
Respiratory parameters
Time frame: up to 24 hours
Hemodynamic parameters
Time frame: up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Background: PubMed 25369152Verdonck P, Kalmar AF, Suy K, Geeraerts T, Vercauteren M, Mottrie A, De Wolf AM, Hendrickx JF. Optic nerve sheath diameter remains constant during robot assisted laparoscopic radical prostatectomy. PLoS One. 2014 Nov 4;9(11):e111916. doi: 10.1371/journal.pone.0111916. eCollection 2014.
- Background: PubMed 25861241Chin JH, Seo H, Lee EH, Lee J, Hong JH, Hwang JH, Kim YK. Sonographic optic nerve sheath diameter as a surrogate measure for intracranial pressure in anesthetized patients in the Trendelenburg position. BMC Anesthesiol. 2015 Mar 31;15:43. doi: 10.1186/s12871-015-0025-9. eCollection 2015.
- Background: PubMed 28284189Blecha S, Harth M, Schlachetzki F, Zeman F, Blecha C, Flora P, Burger M, Denzinger S, Graf BM, Helbig H, Pawlik MT. Changes in intraocular pressure and optic nerve sheath diameter in patients undergoing robotic-assisted laparoscopic prostatectomy in steep 45 degrees Trendelenburg position. BMC Anesthesiol. 2017 Mar 11;17(1):40. doi: 10.1186/s12871-017-0333-3.
- Derived from this study: PubMed 36036829Atasever AG, Salviz EA, Senturk Ciftci H, Bingul ES, Sivrikoz N, Erdem S, Savran Karadeniz M. The Effects of Lateral 45 degrees Head-Down Position and Carbon Dioxide Pneumoperitoneum on the Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Transperitoneal Nephrectomies: A Prospective Observational Study. J Laparoendosc Adv Surg Tech A. 2023 Feb;33(2):171-176. doi: 10.1089/lap.2022.0344. Epub 2022 Aug 25.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Optic Nerve Sheath Diameter, run by Istanbul 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 1 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: finished, as of the sponsor's last update on 11 Jan 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
optic nerve sheath diameter (time frame: up to 24 hours). 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 NCT05185908, which also lists 4 linked publications.
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 11 Jan 2022.