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临床试验/NCT05262140
NCT05262140招募中不适用

In Vivo Quantification of Cervical Collar Efficacy

Methodist Health System1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年1月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Measurements will be taken from videos captured

研究概览

简要总结

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

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Measurements will be taken from videos captured

时间窗: 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

placement of a c-collar

时间窗: 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.

Percent change in the angle of ROM

时间窗: Dec 2021 - Dec 2022

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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