In Vivo Quantification of Cervical Collar Efficacy

NCT05262140 | Recruiting

• 1 other identifier: 071.TRA.2021.D
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective interventional trial with healthy volunteers at Methodist Dallas Medical Center. We anticipate data collection to be completed by December 2023. All study participants will be consented regardless of their role as healthy C-spine volunteer or provider volunteer (Appendix C). No compensation will be provided. Provider volunteers will be classified as:

• Attending
• Resident
• Physician assistant, nurse practitioner, or nurse
• EMS/Paramedic
• Other, as determined by job functions in pre-assessment

Conditions

Spine Injury

Outcome Measures

Primary Outcomes (3)

• placement of a c-collar

  Each volunteer provider will be scored on their placement of a c-collar before and after review of educational materials based on the fit criteria provided by the C-collar manufacturer.

  Dec 2021 - Dec 2022

• Measurements will be taken from videos captured

  Measurements will be taken from videos captured during the study. Image analysis software will be used to measure the angles of motion for each

  Dec 2021 - Dec 2022

• Percent change in the angle of ROM

  Percent change in the angle of ROM in flexion, extension, rotation, and side bending with and without C-collar placement.

  Dec 2021 - Dec 2022

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective interventional trial with healthy volunteers at Methodist Dallas Medical Center. We anticipate data collection to be completed by December 2023. All study participants will be consented regardless of their role as healthy C-spine volunteer or provider volunteer (Appendix C). No compensation will be provided. Provider volunteers will be classified as: * Attending * Resident * Physician assistant, nurse practitioner, or nurse * EMS/Paramedic * Other, as determined by job functions in pre-assessment

You may qualify if:

• C-spine Volunteers:
• Methodist Dallas Medical Center (MDMC) staff
• + years old
• Full ROM of C-spine
• Provider Volunteers:
• Medical provider with permissions at MDMC
• C-collar placement in regular job duties

You may not qualify if:

• C-spine Volunteers:
• \<18 years old
• C-spine trauma
• Previous neck or C-spine surgeries
• Abnormal limitations to C-spine ROM
• Pregnant/nursing
• Claustrophobia
• Pulmonary dysfunction
• Provider Volunteers:
• No previous experience placing C-collars

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75201, United States

RECRUITING

MeSH Terms

Conditions

Spinal Injuries

Condition Hierarchy (Ancestors)

Back Injuries; Wounds and Injuries

Study Officials

• Conner McDaniel, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystee Cooper, DHEd

CONTACT

214-947-1285; clinicalresearch@mhd.com

Zaid Haddadin, MS

CONTACT

214-947-4604; clinicalresearch@mhd.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 2, 2022
• Study Start: January 19, 2022
• Primary Completion: January 19, 2025
• Study Completion: January 19, 2025
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

US (1)