Sex and Age Ultrasound Response to Differential Jugular Vein Pressure

NCT03017937 | Completed Results DMC

• 1 other identifier: 2016-8580
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Concussion, Mild

Outcome Measures

Primary Outcomes (1)

• Neck Collar Size

  measurement of the neck collar size at each pressure level

  1 hour

Study Arms (1)

Q- collar

EXPERIMENTAL

All subjects will wear 3 sizes of the q-collar and ultrasound images of the jugular vein will be measured with each collar. Also, each subject will wear a pressure collar and ultrasound images of the jugular vein will be captured at each pressure point (0.1-0.5)

Device: Q-collar

Interventions

Q-collar DEVICE

capture ultrasound images at each pressure point

Q- collar

Eligibility Criteria

• Age: 7 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Normal healthy volunteer aged 7-60
• Able to provide written consent
• Able to tolerate hypercapnia for 1-2 minutes

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Results Point of Contact

• Title: Kim Foss
• Organization: Cincinnati Chidren's Hospital

kim.foss@cchmc.org

5136365971

Study Officials

• Gregory D Myer, PhD

  Cincinnati Childrens Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 11, 2017
• Study Start: November 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: June 1, 2019
• Last Updated: November 17, 2020
• Results First Posted: November 17, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)