ClinicalTrials.gg
RecruitingNCT05262140Updated Mar 27, 2024

In Vivo Quantification of Cervical Collar Efficacy

An observational study in Spine Injury, sponsored by Methodist Health System. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-27.

Sponsored by Methodist Health System · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Jan 2022; still recruiting 4 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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
Read the 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).

The angle of ROM in flexion, extension, rotation, and side bending without and with C-collar placement in each video will be measured using image analysis software. The decrease in ROM while wearing the C-collar for each encounter will be calculated. Scoring of C-collar placement will be done by an investigator while the provider volunteer is placing the C-collar. Providers will then receive additional information and resources specific to C-collar make/model placement and asked to complete a short survey (Appendix E) related to the content provided.

Provider volunteers will then have training on correct sizing and placing of C-collars and be reassessed in the same manor described above. Percent change will then be calculated for each volunteer provider.

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).

The angle of ROM in flexion, extension, rotation, and side bending without and with C-collar placement in each video will be measured using image analysis software. The decrease in ROM while wearing the C-collar for each encounter will be calculated. Scoring of C-collar placement will be done by an investigator while the provider volunteer is placing the C-collar. Providers will then receive additional information and resources specific to C-collar make/model placement and asked to complete a short survey (Appendix E) related to the content provided.

Provider volunteers will then have training on correct sizing and placing of C-collars and be reassessed in the same manor described above. Percent change will then be calculated for each volunteer provider.

02

Conditions studied

  • Spine Injury

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03

In context

Spinal Injuries

57 studies on the registry are indexed under Spinal Injuries; 15 are open to participants now.

This study's planned enrollment of 60 is below the median of 92 across 22 observational studies indexed under Spinal Injuries.

Browse Spinal Injuries studies →

Lead sponsor

Methodist Health System is the lead sponsor of 170 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Dec 2021 - Dec 2022

  2. 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

    Time frame: Dec 2021 - Dec 2022

  3. 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.

    Time frame: Dec 2021 - Dec 2022

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2022 (actual). Primary completion is estimated for Jan 2025, 36 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 21, 2022
First posted
Mar 2, 2022
StartActual
Jan 19, 2022
Primary completionEst.
Jan 19, 2025
CompletionEst.
Jan 19, 2025
Last update
Mar 27, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05262140
Responsible party
Sponsor
First posted
Mar 2, 2022
Start date
Jan 19, 2022
Primary completion
Jan 19, 2025 (estimated)
Completion
Jan 19, 2025 (estimated)
Last update
Mar 27, 2024

Study contacts

Crystee Cooper, DHEd
Contact
clinicalresearch@mhd.com
214-947-1285
Zaid Haddadin, MS
Contact
clinicalresearch@mhd.com
214-947-4604
Conner McDaniel, MD
principal investigator · The Methodist Hospital Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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