Optic Nerve Sheath DiameterNCT04507620
Effect of Cervical Immobilization on Optic Nerve Sheath Diameter
An observational study of Optic Nerve Sheath Diameter and Point of Care Ultrasound, run by Tanta University at 1 site in Egypt.
Trial summary
Effect of Cervical Immobilization on Optic Nerve Sheath Diameter Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Optic Nerve Sheath Diameter, Point of Care Ultrasound
- What is being tested?
- cervical neck collar
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Jul 2020to 30 Nov 2020
- How long will I take part?
- 6 Months
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This prospective study will be done on 100 medical students, emergency medicine and traumatology residents and assistant lecturers ,Tanta university faculty of medicine, healthy volunteers during a period of 6 months.
Who may be able to join
- Adult healthy volunteers aged more than 18 years
Who cannot join
- Hx of stroke
- Inability to consent,
- Inability to lay flat on a bed or table for 15 min in duration,
- History of glaucoma, globe injury, lens implant,
- Recent refractive surgery (within the past 60 days).
- Uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mohamed Elbahnasawy
Tanta, Gharbia Governorate, 31527
Mohamed G Elbahnasawy, MD, 01091291077 ext. +20, drmogabehn@gmail.com
About this study
Official title: Effect of Cervical Neck Collar and Head Blocks Strapped on the Backboard on Optic Nerve Sheath Diameter
Effect of Cervical Immobilization on Optic Nerve Sheath Diameter
Read the detailed description
Two cervical immobilization devices will be used in this study named cervical neck collar and head blocks strapped on the backboard and optic nerve diameter will be measured using point of care ultrasound and compare the effect of each type of cervical immobilisation on optic nerve sheath diameter.
- Being tested
- cervical neck collar
- Keywords
- cervical immobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical neck collarDevice
Also called head blocks strapped on the backboard
devices used for cervical immobilization
| Study group | Role | What they receive |
|---|---|---|
| cervical neck collar | Not described Receives: Device: cervical neck collar | |
| head blocks strapped on the backboard | Not described Receives: Device: cervical neck collar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of cervical neck collar and head blocks strapped on the backboard on Optic Nerve Sheath Diameter
effect of cervical neck collar and head blocks strapped on the backboard on optic nerve sheath diameter, measured by point of care ultrasound
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start8 Jul 2020
- Primary completion1 Nov 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic Nerve Sheath DiameterStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elbahnasawy, MD, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507620
- Sponsor's protocol ID
- 33935/7/20
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2020
- Last updated
- 11 Aug 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 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cervical Neck Collar and Head Blocks Strapped on the Backboard on Optic Nerve Sheath Diameter
- ClinicalTrials.gov ID
- NCT04507620
- Acronym / sponsor ID
- 33935/7/20
- Keywords
- cervical immobilization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 11 Aug 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.
Effect of Cervical Immobilization on Optic Nerve Sheath Diameter
Detailed description
Two cervical immobilization devices will be used in this study named cervical neck collar and head blocks strapped on the backboard and optic nerve diameter will be measured using point of care ultrasound and compare the effect of each type of cervical immobilisation on optic nerve sheath diameter.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cervical neck collar | – | Device: cervical neck collar |
| head blocks strapped on the backboard | – | Device: cervical neck collar |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This prospective study will be done on 100 medical students, emergency medicine and traumatology residents and assistant lecturers ,Tanta university faculty of medicine, healthy volunteers during a period of 6 months.
Key inclusion criteria (1 listed)
- Adult healthy volunteers aged more than 18 years
Key exclusion criteria (6 listed)
- Hx of stroke
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 |
|---|---|---|
| cervical neck collarAlso: head blocks strapped on the backboarddevices used for cervical immobilization | Device | cervical neck collar, head blocks strapped on the backboard |
Primary outcome
Effect of cervical neck collar and head blocks strapped on the backboard on Optic Nerve Sheath Diameter
Time frame: 6 month
effect of cervical neck collar and head blocks strapped on the backboard on optic nerve sheath diameter, measured by point of care ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- 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.
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 Optic Nerve Sheath Diameter and Point of Care Ultrasound, run by Tanta University at 1 site in Egypt.
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 6 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 11 Aug 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of cervical neck collar and head blocks strapped on the backboard on Optic Nerve Sheath Diameter (time frame: 6 month). 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 11 Aug 2020.