ICP (Intracranial Pressure) IncreaseNCT06367868
Optic Nerve Sheath Diameter: A Non-Invasive Indicator of Intracranial Pressure in the Intensive Care Unit Monitoring
A study testing After 5 ml CSF Drainage in people with ICP (Intracranial Pressure) Increase and Optic Nerve Sheath Diameter, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Determination of high intracranial pressure (ICP) is necessary for the treatment of patients with raised ICP to improve long-term neurological outcomes. Ultrasonographic optic nerve sheath diameter (ONSD) measurement is a noninvasive, easily performed and cost effective technique for detecting high ICP. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ICP (Intracranial Pressure) Increase, Optic Nerve Sheath Diameter, Intracranial Hypertension
- What is being tested?
- After 5 ml CSF Drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Sep 2021to 1 Dec 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 aged patients
- With an external ventricular drainage catheter due to intracranial pathology
Who cannot join
- Under the age of 18
- Orbital tumors
- Graves' disease
- Exophthalmos
- Sarcoidosis
- Optic neuropathy
Show all 9Show fewer
- Meningitis
- Ocular trauma
- Lung diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, Fatıh, 34098
About this study
Official title: Evaluation of the Effect of Cerebrospinal Fluid Drainage on Optic Nerve Sheath Diameter in Patients Installed External Ventricular Drainage Catheter Due to Intracranial Pathology in the Intensive Care Unit
Determination of high intracranial pressure (ICP) is necessary for the treatment of patients with raised ICP to improve long-term neurological outcomes. Ultrasonographic optic nerve sheath diameter (ONSD) measurement is a noninvasive, easily performed and cost effective technique for detecting high ICP.
Read the detailed description
ICP measurements via ventricular catheters provide CSF drainage and ICP reduction. The normal ICP value is less than 15 mmHg in adults. In the literature the correlation of ONSD and invasive ICP measurements were determined. The aim of study is to evaluate the correlation of ONSD and direct ICP measurements and to determine cut off ONSD value to detect ICP ≥15 mmHg.
- Conditions
- ICP (Intracranial Pressure) Increase, Optic Nerve Sheath Diameter, Intracranial Hypertension
- Being tested
- After 5 ml CSF Drainage
- Keywords
- ONSD, ultrasonography, noninvasive, increased intracranial pressure
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
After 5 ml CSF DrainageProcedure or surgery
Optic Nerve Sheath Diameter and Intracranial Pressure measurements will be after 5 ml CSF drainage
| Study group | Role | What they receive |
|---|---|---|
| Before Drainage | Experimental | Optic nerve sheath diameter and intracranial pressure will be measured before CSF drainage Receives: Procedure: After 5 ml CSF Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial Pressure-1 (ICP-1)
Measurement of intracranial pressure before cerebrospinal fluid (CSF) drainage
Measured: baseline time
Optic Nerve Sheath Diameter-1 (ONSD-1)
Measurement of optic nerve sheath diameter before cerebrospinal fluid drainage
Measured: baseline time
Secondary outcomes (2)
Intracranial Pressure-2 (ICP-2)
Measurement of intracranial pressure 2 minutes after cerebrospinal fluid (CSF) drainage
Measured: 2 minutes after CSF drainage
Optic Nerve Sheath Diameter-2 (ONSD-2)
Measurement of optic nerve sheath diameter 2 minutes after cerebrospinal fluid drainage
Measured: 2 minutes after CSF drainage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start9 Sep 2021
- Primary completion1 Jun 2022
- Study completion1 Dec 2022
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 ICP (Intracranial Pressure) IncreaseStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülşah ORAK, Istanbul University - Cerrahpasa
- Investigators
- GULSAH ORAK, Study director, Istanbul University - CerrahpasaOZLEM KORKMAZ DİLMEN, Study chair, Istanbul University - CerrahpasaEREN FATMA AKCİL, Study chair, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367868
- Sponsor's protocol ID
- E-83045809-604.01.02-179951
- Status last verified
- Apr 2024
- First submitted
- 5 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Robba C, Santori G, Czosnyka M, Corradi F, Bragazzi N, Padayachy L, Taccone FS, Citerio G. Optic nerve sheath diameter measured sonographically as non-invasive estimator of intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2018 Aug;44(8):1284-1294. doi: 10.1007/s00134-018-5305-7. Epub 2018 Jul 17.
PubMed 30019201Muller SJ, Henkes E, Gounis MJ, Felber S, Ganslandt O, Henkes H. Non-Invasive Intracranial Pressure Monitoring. J Clin Med. 2023 Mar 13;12(6):2209. doi: 10.3390/jcm12062209.
PubMed 36983213Sharawat IK, Kasinathan A, Bansal A, Sahu JK, Sodhi KS, Dogra MR, Sankhyan N. Evaluation of Optic Nerve Sheath Diameter and Transcranial Doppler As Noninvasive Tools to Detect Raised Intracranial Pressure in Children. Pediatr Crit Care Med. 2020 Nov;21(11):959-965. doi: 10.1097/PCC.0000000000002523.
PubMed 32852360Kimberly HH, Shah S, Marill K, Noble V. Correlation of optic nerve sheath diameter with direct measurement of intracranial pressure. Acad Emerg Med. 2008 Feb;15(2):201-4. doi: 10.1111/j.1553-2712.2007.00031.x.
PubMed 18275454
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Cerebrospinal Fluid Drainage on Optic Nerve Sheath Diameter in Patients Installed External Ventricular Drainage Catheter Due to Intracranial Pathology in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06367868
- Acronym / sponsor ID
- E-83045809-604.01.02-179951
- Conditions
- ICP (Intracranial Pressure) Increase, Optic Nerve Sheath Diameter, Intracranial Hypertension
- Keywords
- ONSD, ultrasonography, noninvasive, increased intracranial pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 16 Apr 2024 (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.
Determination of high intracranial pressure (ICP) is necessary for the treatment of patients with raised ICP to improve long-term neurological outcomes. Ultrasonographic optic nerve sheath diameter (ONSD) measurement is a noninvasive, easily performed and cost effective technique for detecting high ICP.
Detailed description
ICP measurements via ventricular catheters provide CSF drainage and ICP reduction. The normal ICP value is less than 15 mmHg in adults. In the literature the correlation of ONSD and invasive ICP measurements were determined. The aim of study is to evaluate the correlation of ONSD and direct ICP measurements and to determine cut off ONSD value to detect ICP ≥15 mmHg.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Before Drainage | Experimental | Procedure: After 5 ml CSF DrainageOptic nerve sheath diameter and intracranial pressure will be measured before CSF drainage |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-80 aged patients
- With an external ventricular drainage catheter due to intracranial pathology
Key exclusion criteria (9 listed)
- Under the age of 18
- Orbital tumors
- Graves' disease
- Exophthalmos
- Sarcoidosis
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 |
|---|---|---|
| After 5 ml CSF DrainageOptic Nerve Sheath Diameter and Intracranial Pressure measurements will be after 5 ml CSF drainage | Procedure or surgery | Before Drainage |
Primary outcome
Intracranial Pressure-1 (ICP-1)
Time frame: baseline time
Measurement of intracranial pressure before cerebrospinal fluid (CSF) drainage
Optic Nerve Sheath Diameter-1 (ONSD-1)
Time frame: baseline time
Measurement of optic nerve sheath diameter before cerebrospinal fluid drainage
2 secondary outcomes
Intracranial Pressure-2 (ICP-2)
Time frame: 2 minutes after CSF drainage
Optic Nerve Sheath Diameter-2 (ONSD-2)
Time frame: 2 minutes after CSF drainage
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 16 Apr 2024.
- Background: PubMed 30019201Robba C, Santori G, Czosnyka M, Corradi F, Bragazzi N, Padayachy L, Taccone FS, Citerio G. Optic nerve sheath diameter measured sonographically as non-invasive estimator of intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2018 Aug;44(8):1284-1294. doi: 10.1007/s00134-018-5305-7. Epub 2018 Jul 17.
- Background: PubMed 36983213Muller SJ, Henkes E, Gounis MJ, Felber S, Ganslandt O, Henkes H. Non-Invasive Intracranial Pressure Monitoring. J Clin Med. 2023 Mar 13;12(6):2209. doi: 10.3390/jcm12062209.
- Background: PubMed 32852360Sharawat IK, Kasinathan A, Bansal A, Sahu JK, Sodhi KS, Dogra MR, Sankhyan N. Evaluation of Optic Nerve Sheath Diameter and Transcranial Doppler As Noninvasive Tools to Detect Raised Intracranial Pressure in Children. Pediatr Crit Care Med. 2020 Nov;21(11):959-965. doi: 10.1097/PCC.0000000000002523.
- Background: PubMed 18275454Kimberly HH, Shah S, Marill K, Noble V. Correlation of optic nerve sheath diameter with direct measurement of intracranial pressure. Acad Emerg Med. 2008 Feb;15(2):201-4. doi: 10.1111/j.1553-2712.2007.00031.x.
- 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.
GULSAH ORAK study director
Istanbul University - Cerrahpasa
OZLEM KORKMAZ DİLMEN study chair
Istanbul University - Cerrahpasa
EREN FATMA AKCİL study chair
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing After 5 ml CSF Drainage in people with ICP (Intracranial Pressure) Increase and Optic Nerve Sheath Diameter, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 2 inclusion and 9 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 16 Apr 2024. 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 Turkey (Türkiye). 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?
Intracranial Pressure-1 (ICP-1) (time frame: baseline time). The study lists 2 primary outcomes in all. 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 NCT06367868, 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 16 Apr 2024.