- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05262140
In Vivo Quantification of Cervical Collar Efficacy
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
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Crystee Cooper, DHEd
- Phone Number: 214-947-1285
- Email: clinicalresearch@mhd.com
Study Contact Backup
- Name: Zaid Haddadin, MS
- Phone Number: 214-947-4604
- Email: clinicalresearch@mhd.com
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75201
- Recruiting
- Methodist Dallas Medical Center
-
Contact:
- Zaid Haddadin, MS
- Phone Number: (214) 947-4604
- Email: clinicalresearch@mhd.com
-
Contact:
- Crystee Cooper, DHEd
- Phone Number: 214-947-1285
- Email: clinicalresearch@mhd.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Dec 2021 - Dec 2022
|
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
|
Dec 2021 - Dec 2022
|
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.
|
Dec 2021 - Dec 2022
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Conner McDaniel, MD, Methodist Dallas Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 071.TRA.2021.D
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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