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Effect of Cervical Collar on Intracranial Pressure

Effect of Cervical Collar on Optic Nerve Sheath Diameter Measured Sonographically. A Randomized Crossover Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03609879
Enrollment
60
Registered
2018-08-01
Start date
2018-08-01
Completion date
2019-03-22
Last updated
2019-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Optic Nerve Sheath Diameter, Ultrasonography

Keywords

cervical collar, sonography, adult patients, Optic nerve sheath diameter, Ultrasonography

Brief 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.

Interventions

DEVICEAmbu Perfect ACE

patient with a fitted cervical collar (Ambu Perfect ACE) established by an experienced instructor. Cervical collar set up for 20 minutes

DEVICEPhilly One-Peace Collar

patient with a fitted cervical collar (Philly One-Peace Collar) established by an experienced instructor. Cervical collar set up for 20 minutes

DEVICENecloc Collar

patient with a fitted cervical collar (Neclock Collar) established by an experienced instructor. Cervical collar set up for 20 minutes

DEVICENexSplit Plus

patient with a fitted cervical collar (NexSplit Plus) established by an experienced instructor. Cervical collar set up for 20 minutes

DEVICENECKLITE

patient with a fitted cervical collar (NECKLITE) established by an experienced instructor. Cervical collar set up for 20 minutes

Sponsors

Wroclaw Medical University
CollaboratorOTHER
The Cleveland Clinic
CollaboratorOTHER
Lazarski University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* voluntary participation in the study

Exclusion criteria

* head or the spine injury in the last 3 months * eye injuries in the last 3 months * amputation of the eyeball * Headache

Design outcomes

Primary

MeasureTime frameDescription
Optic nerve sheath diameter 5 minutes after collar placement1 day afterDuring 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 placement1 day afterDuring 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.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026