Optic Nerve Sheath DiameterNCT03609879
Effect of Cervical Collar on Intracranial Pressure
A study testing Ambu Perfect ACE, Philly One-Peace Collar and Necloc Collar in people with Optic Nerve Sheath Diameter and Ultrasonography, run by Lazarski University at 2 sites in Poland.
Trial summary
The routine use of cervical collar in emergency medical conditions has recently been questioned. The application of cervical collars, as their opponents point out, results in deterioration of intubation conditions, intensification of pain in the region of mastoid processes, and impaired venous outflow from the head. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Optic Nerve Sheath Diameter, Ultrasonography
- What is being tested?
- Ambu Perfect ACE, Philly One-Peace Collar and Necloc Collar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Aug 2018to 22 Mar 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- voluntary participation in the study
Who cannot join
- head or the spine injury in the last 3 months
- eye injuries in the last 3 months
- amputation of the eyeball
- Headache
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Faculty of Medicine, Lazarski University
Warsaw, Masovian Voivodeship, 02-662
Lazarsku University
Warsaw, Masovian Voivodeship, 02-662
About this study
Official title: Effect of Cervical Collar on Optic Nerve Sheath Diameter Measured Sonographically. A Randomized Crossover Trial
The routine use of cervical collar in emergency medical conditions has recently been questioned. The application of cervical collars, as their opponents point out, results in deterioration of intubation conditions, intensification of pain in the region of mastoid processes, and impaired venous outflow from the head.
- Conditions
- Optic Nerve Sheath Diameter, Ultrasonography
- Being tested
- Ambu Perfect ACE, Philly One-Peace Collar, Necloc Collar, NexSplit Plus, NECKLITE
- Keywords
- cervical collar, sonography, adult patients, Optic nerve sheath diameter, Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambu Perfect ACEDevice
patient with a fitted cervical collar (Ambu Perfect ACE) established by an experienced instructor. Cervical collar set up for 20 minutes
Philly One-Peace CollarDevice
patient with a fitted cervical collar (Philly One-Peace Collar) established by an experienced instructor. Cervical collar set up for 20 minutes
Necloc CollarDevice
patient with a fitted cervical collar (Neclock Collar) established by an experienced instructor. Cervical collar set up for 20 minutes
NexSplit PlusDevice
patient with a fitted cervical collar (NexSplit Plus) established by an experienced instructor. Cervical collar set up for 20 minutes
NECKLITEDevice
patient with a fitted cervical collar (NECKLITE) established by an experienced instructor. Cervical collar set up for 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| without cervical collar | No intervention | baseline - without cervical collar |
| with cervical collar | Experimental | scenarios with cervical collars Receives: Device: Ambu Perfect ACE; Device: Philly One-Peace Collar; Device: Necloc Collar; Device: NexSplit Plus; Device: NECKLITE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve sheath diameter 5 minutes after collar placement
During each evaluation with Optic nerve sheath diameter, at least three measurements were attempted from each eye. The ONSD was measured 3 mm behind the retina. All scans were performed using a 13-6 MHz linear-array probe and a high resolution optimization setting.
Measured: 1 day after
Optic nerve sheath diameter 20 minutes after collar placement
During each evaluation with Optic nerve sheath diameter, at least three measurements were attempted from each eye. The ONSD was measured 3 mm behind the retina. All scans were performed using a 13-6 MHz linear-array probe and a high resolution optimization setting.
Measured: 1 day after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Aug 2018
- Primary completion22 Mar 2019
- Study completion22 Mar 2019
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 Optic Nerve 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lazarski University
- Sponsor type
- University, hospital or other
- Collaborators
- Wroclaw Medical University, The Cleveland Clinic
- Responsible party
- Principal investigator, Łukasz Szarpak, Lazarski University
- Investigators
- Lukasz Szarpak, Principal investigator, Lazarski University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609879
- Sponsor's protocol ID
- ONSD_2018_UL
- Status last verified
- Sep 2019
- First submitted
- 25 Jul 2018
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Research data will be available from the principal investigator
Publications
Szarpak L, Truszewski Z, Kurowski A, Samarin S, Evrin T, Adamczyk P, Czyzewski L. Knowledge, attitude, and practices of paramedics regarding optic nerve sheath diameter ultrasonography. Am J Emerg Med. 2016 Jun;34(6):1160-1. doi: 10.1016/j.ajem.2016.02.063. Epub 2016 Mar 3. No abstract available.
PubMed 26994678Ladny M, Smereka J, Ahuja S, Szarpak L, Ruetzler K, Ladny JR. Effect of 5 different cervical collars on optic nerve sheath diameter: A randomized crossover trial. Medicine (Baltimore). 2020 Apr;99(16):e19740. doi: 10.1097/MD.0000000000019740.
PubMed 32311968
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cervical Collar on Optic Nerve Sheath Diameter Measured Sonographically. A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT03609879
- Acronym / sponsor ID
- ONSD_2018_UL
- Conditions
- Optic Nerve Sheath Diameter, Ultrasonography
- Keywords
- cervical collar, sonography, adult patients, Optic nerve sheath diameter, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lazarski UniversityUniversity, hospital or other
- Collaborators
- Wroclaw Medical University, The Cleveland Clinic
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 22 Mar 2019 (actual)
- First posted
- 1 Aug 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.
The routine use of cervical collar in emergency medical conditions has recently been questioned. The application of cervical collars, as their opponents point out, results in deterioration of intubation conditions, intensification of pain in the region of mastoid processes, and impaired venous outflow from the head.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| without cervical collar | No intervention | –baseline - without cervical collar |
| with cervical collar | Experimental | Device: Ambu Perfect ACE, Device: Philly One-Peace Collar, Device: Necloc Collar, Device: NexSplit Plus, Device: NECKLITEscenarios with cervical collars |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- voluntary participation in the study
Key exclusion criteria (4 listed)
- head or the spine injury in the last 3 months
- eye injuries in the last 3 months
- amputation of the eyeball
- Headache
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 |
|---|---|---|
| Ambu Perfect ACEpatient with a fitted cervical collar (Ambu Perfect ACE) established by an experienced instructor. Cervical collar set up for 20 minutes | Device | with cervical collar |
| Philly One-Peace Collarpatient with a fitted cervical collar (Philly One-Peace Collar) established by an experienced instructor. Cervical collar set up for 20 minutes | Device | with cervical collar |
| Necloc Collarpatient with a fitted cervical collar (Neclock Collar) established by an experienced instructor. Cervical collar set up for 20 minutes | Device | with cervical collar |
| NexSplit Pluspatient with a fitted cervical collar (NexSplit Plus) established by an experienced instructor. Cervical collar set up for 20 minutes | Device | with cervical collar |
| NECKLITEpatient with a fitted cervical collar (NECKLITE) established by an experienced instructor. Cervical collar set up for 20 minutes | Device | with cervical collar |
Primary outcome
Optic nerve sheath diameter 5 minutes after collar placement
Time frame: 1 day after
During each evaluation with Optic nerve sheath diameter, at least three measurements were attempted from each eye. The ONSD was measured 3 mm behind the retina. All scans were performed using a 13-6 MHz linear-array probe and a high resolution optimization setting.
Optic nerve sheath diameter 20 minutes after collar placement
Time frame: 1 day after
During each evaluation with Optic nerve sheath diameter, at least three measurements were attempted from each eye. The ONSD was measured 3 mm behind the retina. All scans were performed using a 13-6 MHz linear-array probe and a high resolution optimization setting.
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 20 Sep 2019.
- Background: PubMed 26994678Szarpak L, Truszewski Z, Kurowski A, Samarin S, Evrin T, Adamczyk P, Czyzewski L. Knowledge, attitude, and practices of paramedics regarding optic nerve sheath diameter ultrasonography. Am J Emerg Med. 2016 Jun;34(6):1160-1. doi: 10.1016/j.ajem.2016.02.063. Epub 2016 Mar 3. No abstract available.
- Derived from this study: PubMed 32311968Ladny M, Smereka J, Ahuja S, Szarpak L, Ruetzler K, Ladny JR. Effect of 5 different cervical collars on optic nerve sheath diameter: A randomized crossover trial. Medicine (Baltimore). 2020 Apr;99(16):e19740. doi: 10.1097/MD.0000000000019740.
- Individual participant dataSharing planned: Undecided. Research data will be available from the principal investigator
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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.
Lukasz Szarpak principal investigator
Lazarski University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambu Perfect ACE, Philly One-Peace Collar and Necloc Collar in people with Optic Nerve Sheath Diameter and Ultrasonography, run by Lazarski University at 2 sites in Poland.
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 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 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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 5 minutes after collar placement (time frame: 1 day after). 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 NCT03609879, 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 20 Sep 2019.