- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05185908
The Effects of Lateral 45° Downward Position on the Optic Nerve Sheath Diameter
December 22, 2021 updated by: Meltem Savran Karadeniz, Istanbul University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
26
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- All patients older than 18 years who have undergone laparoscopic transperitoneal nephrectomy.
Exclusion Criteria:
- Those who have neurological and cerebrovascular disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1
The patients undergoing laparoscopic transperitoneal nephrectomy.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
up to 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory parameters
Time Frame: up to 24 hours
|
Peak inspiratory pressure
|
up to 24 hours
|
|
Hemodynamic parameters
Time Frame: up to 24 hours
|
Mean arterial pressure
|
up to 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. Erratum in: PLoS One. 2015;10(2):e0118014.
- Chin 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.
- Blecha 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.
- Atasever AG, Salviz EA, Şentürk Çiftçi H, Bingül ES, Sivrikoz N, Erdem S, Savran Karadeniz M. The Effects of Lateral 45° 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. 2022 Aug 25. doi: 10.1089/lap.2022.0344. [Epub ahead of print]
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2016
Primary Completion (Actual)
March 2, 2017
Study Completion (Actual)
January 1, 2019
Study Registration Dates
First Submitted
December 5, 2021
First Submitted That Met QC Criteria
December 22, 2021
First Posted (Actual)
January 11, 2022
Study Record Updates
Last Update Posted (Actual)
January 11, 2022
Last Update Submitted That Met QC Criteria
December 22, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OpticNerveSheathIU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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