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Clinical Trials/NCT05262140
NCT05262140RecruitingNot Applicable

In Vivo Quantification of Cervical Collar Efficacy

Methodist Health System1 site in 1 country60 target enrollmentStarted: January 19, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
1
Primary Endpoint
Measurements will be taken from videos captured

Study Overview

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

Detailed Description

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 Prior to placing C-collars, provider volunteers who will be placing C-collars will answer a questionnaire about their medical experience, their current position, their confidence in effective C-collar placement, and if they had formal C-collar training (Appendix D).

Healthy C-spine volunteers will lie supine. Cameras will be placed directly superior, anterior, and lateral to the volunteer's head. C-spine volunteers will be asked to actively move their head to the maximal flexion, extension, bilateral rotation, and bilateral side bending to assess baseline ROM.

Provider volunteers will individually place a C-collar on the C-spine volunteer's neck. They will have a range of sizes to choose from or adjustable units as applicable. The provider volunteer will be able to independently select and adjust a collar to best fit the C-spine volunteer.

The C-spine volunteer will then actively move their head to the maximal flexion, extension, bilateral rotation, and bilateral side bending with the C-collar on. ROM will be analyzed from video taken. This process will be repeated for each C-spine volunteer and each provider volunteer (Minimum 3 volunteers per 1 provider volunteer).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Measurements will be taken from videos captured

Time Frame: Dec 2021 - Dec 2022

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

Percent change in the angle of ROM

Time Frame: Dec 2021 - Dec 2022

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

placement of a c-collar

Time Frame: Dec 2021 - Dec 2022

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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