Intracranial Pressure IncreaseNCT04758091
Effect of Tourniquet Application on Optic Nerve Sheath Diameter
An observational study of Intracranial Pressure Increase, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study to investigate the effect of tourniquet application on optic nerve sheath diameter (ONSD) and cerebral oxygenation during lower extremity surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intracranial Pressure Increase
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2019to 1 Jun 2020
- How long will I take part?
- 1 Day
- 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: lower extremity surgery with tourniquet
Who may be able to join
- ASA I-II risk group over the age of 18
- Operation planned under general anesthesia
- Lower extremity surgery with a tourniquet
- Agreeing to volunteer for research with an informed consent form
Who cannot join
- Emergency surgical procedures
- neurological disease, carotid disease
- Previous intracranial or ocular surgery
- Neurological symptoms
- cerebral edema, high IntraCranial Pressure
- Presence of glaucoma
Show all 12Show fewer
- Body mass index (BMI)> 35
- Uncontrolled hypertension
- Diabetic retinopathy
- anemia
- coronary artery disease
- peripheral artery disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University Medicine Faculty
Zonguldak, Kozlu, 67600
About this study
Official title: The Effect of Tourniquet Application on Optic Nerve Sheath Diameter and Cerebral Oxygenation During Lower Extremity Surgery
The aim of the study to investigate the effect of tourniquet application on optic nerve sheath diameter (ONSD) and cerebral oxygenation during lower extremity surgery.
- Conditions
- Intracranial Pressure Increase
- Keywords
- Optic Nerve Sheath Diameter, Tourniquet, Cerebral Oxygenation
- Medical subject headings
- Intracranial Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
optic nerve diameter
measuring the change in optic nerve diameter
Measured: during the surgery
regional cerebral oxgenation
measurement rSo2 by Near Infrared spectroscopy
Measured: during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start15 Apr 2019
- Primary completion15 Dec 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Pressure IncreaseStudies 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
- 1 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahar Say, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758091
- Sponsor's protocol ID
- 2019-58-03/04
- Status last verified
- Feb 2021
- First submitted
- 8 Feb 2021
- Last updated
- 17 Feb 2021
- Results posted
- 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 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tourniquet Application on Optic Nerve Sheath Diameter and Cerebral Oxygenation During Lower Extremity Surgery
- ClinicalTrials.gov ID
- NCT04758091
- Acronym / sponsor ID
- 2019-58-03/04
- Conditions
- Intracranial Pressure Increase
- Keywords
- Optic Nerve Sheath Diameter, Tourniquet, Cerebral Oxygenation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 17 Feb 2021 (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.
The aim of the study to investigate the effect of tourniquet application on optic nerve sheath diameter (ONSD) and cerebral oxygenation during lower extremity surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- lower extremity surgery with tourniquet
Key inclusion criteria (4 listed)
- ASA I-II risk group over the age of 18
- Operation planned under general anesthesia
- Lower extremity surgery with a tourniquet
- Agreeing to volunteer for research with an informed consent form
Key exclusion criteria (12 listed)
- Emergency surgical procedures
- neurological disease, carotid disease
- Previous intracranial or ocular surgery
- Neurological symptoms
- cerebral edema, high IntraCranial Pressure
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
optic nerve diameter
Time frame: during the surgery
measuring the change in optic nerve diameter
regional cerebral oxgenation
Time frame: during the surgery
measurement rSo2 by Near Infrared spectroscopy
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 17 Feb 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Pressure Increase, run by Zonguldak Bulent Ecevit University 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 4 inclusion and 12 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 17 Feb 2021. 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?
optic nerve diameter (time frame: during the surgery). 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?
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 17 Feb 2021.