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.
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
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- Claustrophobia
- Pulmonary dysfunction
- Provider Volunteers:
- No previous experience placing C-collars
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- 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
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.
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
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
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.
- First posted2 Mar 2022
- Study start19 Jan 2022
- Primary completion19 Jan 2025 (estimated)
- Study completion19 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Conner McDaniel, MD, Principal investigator, The Methodist Hospital Research Institute
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Quantification of Cervical Collar Efficacy
- ClinicalTrials.gov ID
- NCT05262140
- Acronym / sponsor ID
- 071.TRA.2021.D
- Conditions
- Spine Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 19 Jan 2025 (estimated)
- Study completion
- 19 Jan 2025 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (7 listed)
- Methodist Dallas Medical Center (MDMC) staff
- 18+ years old
- Full ROM of C-spine
- Medical provider with permissions at MDMC
- C-collar placement in regular job duties
Key exclusion criteria (10 listed)
- C-spine Volunteers:
- No previous experience placing C-collars
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Conner McDaniel, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
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.