N/A
N=155
Sex and Age Ultrasound Response to Differential Jugular Vein Pressure
Concussion, Mild
Bottom Line
View on ClinicalTrials.gov: NCT03017937 ↗Enrolled (actual)
155
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Neck Collar Size — 11.15; 11.11; 11.25; 11.21 inches
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Q-collar (Device)
- Age
- Pediatric, Adult · 7+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neck Collar Size |
11.15; 11.11; 11.25; 11.21; 11.145; 11.11 | — |
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.
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.