Intracranial HypotensionNCT04301830
Postoperative Changes in Optic Nerve Sheath Diameter in Patients Undergoing Spinal Anesthesia for Cesarean Delivery
An observational study of Intracranial Hypotension, run by SMG-SNU Boramae Medical Center.
Trial summary
This is observational study. The investigator will measure optic nerve sheath diameter by ultrasound on the eye after cesarean section under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Intracranial Hypotension
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to Apr 2022
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cesarean section under spinal anesthesia.
Who may be able to join
- Patients undergoing cesarean section under spinal anesthesia
Who cannot join
- Patients who did not agree to participate in the study
- Patients has ophthalmic diseases
- Patients has previous history of ophthalmic surgery.
- Patients has neurological disorders.
- Patients has history of head surgery.
About this study
This is observational study. The investigator will measure optic nerve sheath diameter by ultrasound on the eye after cesarean section under spinal anesthesia.
- Conditions
- Intracranial Hypotension
- Medical subject headings
- Intracranial Hypotension
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 |
|---|---|---|
| Spinal anesthesia | Patients undergoing cesarean section under spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change optic nerve sheath diameter
Change in Optic nerve sheathe diameter from baseline, 1,,6,24 and 48 hours after completion of surgery
Measured: 0,1,6,24 and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study startApr 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intracranial HypotensionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SMG-SNU Boramae Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Hwang, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301830
- Sponsor's protocol ID
- 20200306
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2020
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Watanabe A, Horikoshi T, Uchida M, Ishigame K, Kinouchi H. Decreased diameter of the optic nerve sheath associated with CSF hypovolemia. AJNR Am J Neuroradiol. 2008 May;29(5):863-4. doi: 10.3174/ajnr.A1027. Epub 2008 Feb 29.
PubMed 18310231Bauerle J, Gizewski ER, Stockhausen Kv, Rosengarten B, Berghoff M, Grams AE, Kaps M, Nedelmann M. Sonographic assessment of the optic nerve sheath and transorbital monitoring of treatment effects in a patient with spontaneous intracranial hypotension: case report. J Neuroimaging. 2013 Apr;23(2):237-9. doi: 10.1111/j.1552-6569.2011.00640.x. Epub 2011 Sep 1.
PubMed 21883624
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Changes in Optic Nerve Sheath Diameter in Patients Undergoing Spinal Anesthesia for Cesarean Delivery
- ClinicalTrials.gov ID
- NCT04301830
- Acronym / sponsor ID
- 20200306
- Conditions
- Intracranial Hypotension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 10 Mar 2020 (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.
This is observational study. The investigator will measure optic nerve sheath diameter by ultrasound on the eye after cesarean section under spinal anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal anesthesia | – | –Patients undergoing cesarean section under spinal anesthesia |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cesarean section under spinal anesthesia.
Key inclusion criteria (1 listed)
- Patients undergoing cesarean section under spinal anesthesia
Key exclusion criteria (5 listed)
- Patients who did not agree to participate in the study
- Patients has ophthalmic diseases
- Patients has previous history of ophthalmic surgery.
- Patients has neurological disorders.
- Patients has history of head surgery.
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
Change optic nerve sheath diameter
Time frame: 0,1,6,24 and 48 hours
Change in Optic nerve sheathe diameter from baseline, 1,,6,24 and 48 hours after completion of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Background: PubMed 18310231Watanabe A, Horikoshi T, Uchida M, Ishigame K, Kinouchi H. Decreased diameter of the optic nerve sheath associated with CSF hypovolemia. AJNR Am J Neuroradiol. 2008 May;29(5):863-4. doi: 10.3174/ajnr.A1027. Epub 2008 Feb 29.
- Background: PubMed 21883624Bauerle J, Gizewski ER, Stockhausen Kv, Rosengarten B, Berghoff M, Grams AE, Kaps M, Nedelmann M. Sonographic assessment of the optic nerve sheath and transorbital monitoring of treatment effects in a patient with spontaneous intracranial hypotension: case report. J Neuroimaging. 2013 Apr;23(2):237-9. doi: 10.1111/j.1552-6569.2011.00640.x. Epub 2011 Sep 1.
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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 Intracranial Hypotension, run by SMG-SNU Boramae Medical Center.
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 5 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 10 Mar 2020. 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?
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?
Change optic nerve sheath diameter (time frame: 0,1,6,24 and 48 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 NCT04301830, which also lists 2 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 10 Mar 2020.