Optic Neve Sheath DiameterNCT03785314
Optic Nerve Sheath Diameter Difference
A study testing thoracic epidural catheterization in people with Optic Neve Sheath Diameter, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
Intracranial pressure is measured indirectly using optic nerve sheath diameter with ultrasound. It is reported that epidural pressure varies according to different posture ( lateral decubitus vs. sitting position). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Optic Neve Sheath Diameter
- What is being tested?
- thoracic epidural catheterization
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jan 2019to 30 Dec 2019
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lung cancer
- liver cancer
- stomach cancer
- pancreas cancer
Who cannot join
- coagulopathy
- infection
- previous spine fusion at thoracic level
- previous brain surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Posture on Optic Nerve Sheath Diameter During Thoracic Epidural Catheterization
Intracranial pressure is measured indirectly using optic nerve sheath diameter with ultrasound. It is reported that epidural pressure varies according to different posture ( lateral decubitus vs. sitting position).
This study is designed to measure the optic nerve sheath diameter in lateral decubitus and sitting position, respectively.
Read the detailed description
According to previous study, injection of different volume of local anesthetics (1.0 ml/kg vs. 1.5 ml/kg) during caudal anesthesia, high volume of local anesthetics resulted in significant increase of intracranial pressure (ICP). Increase of ICP can reduce regional cerebral flow and oxygen saturation causing the safety of patients. In addition, increase of ICP can result in headache, syncope, and transient loss of visual acuity. Although it is very invasive method, ICP can be measured directly at the brain parenchyme. Among methods to measure the ICP indirectly, measurement of optic nerve sheath diameter using ultrasound is known to reflect the degree of ICP. It is reported that optic nerve sheath diameter increases when higher volume of medication is injected during epidural anesthesia. Previous reports showed that epidural pressure varies according to different posture. When epidural pressure was measured in patients of spinal stenosis, lumbar flexion showed lower epidural pressure than epidural pressure of lumbar extension. In addition, when epidural pressure was measured in the sitting position, it showed lower pressure than pressure of lateral decubitus.
- Conditions
- Optic Neve Sheath Diameter
- Being tested
- thoracic epidural catheterization
- Keywords
- Optic Nerve Sheath Diameter Different Position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic epidural catheterizationOther
thoracic epidural catheterization with different posture
| Study group | Role | What they receive |
|---|---|---|
| injection under sitting position | Active comparator | saline injection under sitting position during thoracic epidural catheterization Receives: Other: thoracic epidural catheterization |
| injection under lateral decubitus position | Active comparator | saline injection under lateral decubitus position during thoracic epidural catheterization Receives: Other: thoracic epidural catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
optic nerve sheath diameter change among 4 time period
optic nerve sheath diameter change among 4 time period using ultrasound
Measured: Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start2 Jan 2019
- Primary completion30 Oct 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic Neve Sheath DiameterStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Hee Hong, Keimyung University Dongsan Medical Center
- Investigators
- Ji Hee Hong, PhD, Principal investigator, Keimyung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785314
- Sponsor's protocol ID
- 2018-11-039
- Status last verified
- Aug 2019
- First submitted
- 20 Dec 2018
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Posture on Optic Nerve Sheath Diameter During Thoracic Epidural Catheterization
- ClinicalTrials.gov ID
- NCT03785314
- Acronym / sponsor ID
- 2018-11-039
- Conditions
- Optic Neve Sheath Diameter
- Keywords
- Optic Nerve Sheath Diameter Different Position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 24 Dec 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.
Intracranial pressure is measured indirectly using optic nerve sheath diameter with ultrasound. It is reported that epidural pressure varies according to different posture ( lateral decubitus vs. sitting position).
This study is designed to measure the optic nerve sheath diameter in lateral decubitus and sitting position, respectively.
Detailed description
According to previous study, injection of different volume of local anesthetics (1.0 ml/kg vs. 1.5 ml/kg) during caudal anesthesia, high volume of local anesthetics resulted in significant increase of intracranial pressure (ICP). Increase of ICP can reduce regional cerebral flow and oxygen saturation causing the safety of patients. In addition, increase of ICP can result in headache, syncope, and transient loss of visual acuity. Although it is very invasive method, ICP can be measured directly at the brain parenchyme. Among methods to measure the ICP indirectly, measurement of optic nerve sheath diameter using ultrasound is known to reflect the degree of ICP. It is reported that optic nerve sheath diameter increases when higher volume of medication is injected during epidural anesthesia. Previous reports showed that epidural pressure varies according to different posture. When epidural pressure was measured in patients of spinal stenosis, lumbar flexion showed lower epidural pressure than epidural pressure of lumbar extension. In addition, when epidural pressure was measured in the sitting position, it showed lower pressure than pressure of lateral decubitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| injection under sitting position | Active comparator | Other: thoracic epidural catheterizationsaline injection under sitting position during thoracic epidural catheterization |
| injection under lateral decubitus position | Active comparator | Other: thoracic epidural catheterizationsaline injection under lateral decubitus position during thoracic epidural catheterization |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- lung cancer
- liver cancer
- stomach cancer
- pancreas cancer
Key exclusion criteria (4 listed)
- coagulopathy
- infection
- previous spine fusion at thoracic level
- previous brain surgery
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 |
|---|---|---|
| thoracic epidural catheterizationthoracic epidural catheterization with different posture | Other | injection under lateral decubitus position, injection under sitting position |
Primary outcome
optic nerve sheath diameter change among 4 time period
Time frame: Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention
optic nerve sheath diameter change among 4 time period using ultrasound
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 24 Feb 2020.
- Individual participant dataSharing planned: No
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.
Ji Hee Hong, PhD principal investigator
Keimyung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thoracic epidural catheterization in people with Optic Neve Sheath Diameter, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
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 4 inclusion and 4 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 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 change among 4 time period (time frame: Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2020.