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Spine InjuryNCT05262140

In Vivo Quantification of Cervical Collar Efficacy

An observational study of Spine Injury, run by Methodist Health System at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spine Injury
How many people
60 participants
Where
1 siteUnited States
Study dates
19 Jan 2022to 19 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • C-spine Volunteers:
  • <18 years old
  • C-spine trauma
  • Previous neck or C-spine surgeries
  • Abnormal limitations to C-spine ROM
  • Pregnant/nursing
Show all 10Show fewer
  • Claustrophobia
  • Pulmonary dysfunction
  • Provider Volunteers:
  • No previous experience placing C-collars

Trial locations and contacts

1 site in 1 country.

Crystee Cooper, DHEd contact

214-947-1285

clinicalresearch@mhd.com

Zaid Haddadin, MS contact

214-947-4604

clinicalresearch@mhd.com

United States1 site, 1 recruiting
  • Methodist Dallas Medical Center

    Dallas, Texas, 75201

    Crystee Cooper, DHEd, 214-947-1285, clinicalresearch@mhd.com

    Zaid Haddadin, MS, (214) 947-4604, clinicalresearch@mhd.com

    Recruiting

Other trials in United States

About this study

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.

Conditions
Spine Injury
Medical subject headings
Spinal Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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

    Measured: 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.

    Measured: Dec 2021 - Dec 2022

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2022
  2. Study start19 Jan 2022
  3. Primary completion19 Jan 2025 (estimated)
  4. Study completion19 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05262140
Sponsor's protocol ID
071.TRA.2021.D
Status last verified
Mar 2024
First submitted
21 Feb 2022
Last updated
27 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Spine Injury, run by Methodist Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Crystee Cooper, DHEd (214-947-1285, clinicalresearch@mhd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

placement of a c-collar (time frame: Dec 2021 - Dec 2022). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.

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