Effect of Cervical Collar on Intracranial Pressure

Study Overview
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Brief Summary
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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.

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

Conditions
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Optic Nerve Sheath Diameter, Ultrasonography

Intervention / Treatment
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* Device: Ambu Perfect ACE
* Device: Philly One-Peace Collar
* Device: Necloc Collar
* Device: NexSplit Plus
* Device: NECKLITE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: without cervical collar<br>baseline - without cervical collar | |
| Experimental: with cervical collar<br>scenarios with cervical collars | Device: Ambu Perfect ACE<br>* patient with a fitted cervical collar (Ambu Perfect ACE) established by an experienced instructor. Cervical collar set up for 20 minutes<br>Device: Philly One-Peace Collar<br>* patient with a fitted cervical collar (Philly One-Peace Collar) established by an experienced instructor. Cervical collar set up for 20 minutes<br>Device: Necloc Collar<br>* patient with a fitted cervical collar (Neclock Collar) established by an experienced instructor. Cervical collar set up for 20 minutes<br>Device: NexSplit Plus<br>* patient with a fitted cervical collar (NexSplit Plus) established by an experienced instructor. Cervical collar set up for 20 minutes<br>Device: NECKLITE<br>* patient with a fitted cervical collar (NECKLITE) established by an experienced instructor. Cervical collar set up for 20 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 1 day after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical collar, sonography, adult patients, Optic nerve sheath diameter, Ultrasonography