N/A
Completed N=155
Sex and Age Ultrasound Response to Differential Jugular Vein Pressure
Concussion, Mild
Source: ClinicalTrials.gov NCT03017937 ↗
Enrolled (actual)
155
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Neck Collar Size — 11.15; 11.11; 11.25; 11.21 inches
Summary
Clinical trials have suggested that this device is effective in mitigating changes in brain structure and function in athlete populations. The purpose of the current study is to measure the response of the jugular vein to various pressures applied by a generic compression device across various ages and gender. The relative jugular vein response will be measured using ultrasound.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neck Collar Size |
11.15; 11.11; 11.25; 11.21; 11.145; 11.11 | — |
Eligibility Criteria
Inclusion Criteria
- Normal healthy volunteer aged 7-60
- Able to provide written consent
- Able to tolerate hypercapnia for 1-2 minutes
Exclusion Criteria
- Unable to provide written consent
- History of neurological deficits, previous cerebral infarction, or severe head trauma as indicated through pre-season screening:
- Medical contraindications to restriction of venous outflow via the internal jugular veins (known increased intracerebral pressure, metabolic acidosis or alkalosis)
- Glaucoma (Narrow Angle or Normal Tension)
- Hydrocephalus
- Recent penetrating brain trauma (within 6 months)
- Known carotid hypersensitivity
- Known increased intracranial pressure
- Central vein thrombosis
- Any known airway obstruction
- Any known seizure disorder
Data sourced from ClinicalTrials.gov (NCT03017937). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.