Cervical Spine InjuryMINERVANCT05605847
Adherence of Imaging Order to the 2020 French Guidelines for Patients With Cervical Spine Injury in the Emergency Setting
An observational study of Cervical Spine Injury, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Cervical spine trauma is a frequent reason for consultation in emergency medicine. It concerns approximately 10,000 patients admitted to the emergency room each year in France. There are two types of cervical spine trauma: penetrating and non-penetrating. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Spine Injury
- How many people
- 136 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2022to 31 Dec 2023
- 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: Patient consulting the GHPSJ emergency department for a non-penetrating cervical spine injury from 01/01/2021 to 12/31/2021
Who may be able to join
- Patient whose age is ≥ 18 years
- Patient consulting the GHPSJ emergency department for a non-penetrating cervical spine injury from 01/01/2021 to 12/31/2021
- French-speaking patient
Who cannot join
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
- Patient objecting to the use of his data for this research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adherence of Imaging Order to the 2020 French Guidelines for Patients With Cervical Spine Injury in the Emergency Setting: a Retrospective Cohort Study
Cervical spine trauma is a frequent reason for consultation in emergency medicine. It concerns approximately 10,000 patients admitted to the emergency room each year in France. There are two types of cervical spine trauma: penetrating and non-penetrating. Non-penetrating injuries are the most frequent and can be classified according to the mechanism involved. Whiplash is the most common type of trauma in emergency medicine. The injuries associated with this type of trauma predominate in the mobile spinal segment and are most often benign: only 2 to 3% of conscious patients consulting the emergency room actually present with cervical injuries such as fractures, dislocations or unstable sprains. In emergency medicine, the paradigm is therefore to identify patients at risk of complications, minimizing the need for unnecessary and radiating imaging. Although cervical spine trauma is a frequent reason for emergency room visits, the incidence of anatomical lesions is generally low and the X-rays prescribed most often do not show any abnormality. For cervical lesion screening to be safe and effective, the screening rules must have a high sensitivity, a low negative likelihood ratio, and a low false positive rate. Two clinical prediction rules have been extensively evaluated in the literature to guide imaging for nonpenetrating cervical injuries: the National Emergency X-Radiography Utilization Study (NEXUS) rule and the Canadian C-Spine 5 rule. The NEXUS rule4 applies to any clinically stable patient (Glasgow Coma Scale 15, systolic blood pressure ≥ 90 mmHg, and respiratory rate between 10 and 24/min) presenting to the emergency department with a nonpenetrating trauma. The criteria constituting the NEXUS clinical rule are:
- Absence of tenderness on palpation of the posterior cervical midline ;
- Normal state of alertness (Glasgow Coma Scale 15);
- Absence of focal neurological deficit;
- Absence of signs of intoxication;
- Absence of distracting pain (other pain that may mask neck pain, e.g., long bone fracture).
Read more
If these 5 criteria are present, the risk of cervical spine injury is low and no imaging is recommended.
The Canadian C-Spine 5 rule applies to patients who are 16 years of age or older; conscious with a Glasgow Coma Scale of 15; stable (systolic blood pressure ≥ 90 mmHg and respiratory rate between 10 and 24/min); and have had head or neck trauma in the past 48 hours. As soon as the rules of clinical prediction do not make it possible to rule out the hypothesis of a spinal injury, the exploration of cervical trauma traditionally involves the performance of radiographic images. They must include the following incidences: face, profile and open mouth centered on the cervico-occipital hinge ("open mouth odontoid"). Nevertheless, the sensitivity of these conventional radiographs for the detection of cervical spine lesions is poor, about 50%. Thus, the use of standard radiographs is usually limited to conscious, ambulatory patients at low risk of spinal injury. Conversely, the cervical CT is the reference examination for the detection of spinal bone lesions with a sensitivity close to 100%. Its sensitivity is superior to that of radiographic images in both high-risk and low-risk patients with spinal injuries. Difficulty of access and exposure to ionizing radiation, which is lower with standard radiography, generally influence the choice of imaging in the emergency room. In December 2020, the French High Authority for Health published a sheet on the relevance of cervical imaging in the context of non-penetrating cervical trauma. This sheet proposes a practical table according to the precise clinical context of the patient as well as the best first-line imaging. These good practice recommendations were part of an approach to improve the relevance of care. Cervical spine imaging for patients admitted to the emergency department for non-penetrating cervical spine trauma was recommended in one of the following situations
- patient 65 years of age or older ;
- patient unstable or with consciousness disorders or neurological signs;
- imaging recommended by one of the following two rules: NEXUS or Canadian C-Spine;
- a history of ankylosing spine (ankylosing spondylitis, hyperostosis, etc.), even in case of "minor" trauma;
- if a cervical artery dissection is suspected. Investigator's hypothesis is that the HAS recommendations of good cervical imaging practices for non-penetrating cervical trauma are difficult to apply routinely in emergency departments for several reasons: the frequency of consultations for cervical trauma, the limited availability of emergency CT scans, and the fear of radiation and unnecessary additional costs in emergency situations. Investigators wish to determine the actual rate of application of the clinical rules recommended by the HAS in the GHPSJ emergency department and the factors predicting their non-application by the GHPSJ team of emergency physicians.
- Conditions
- Cervical Spine Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with non-penetrating cervical trauma in the emergency department for whom there is a lack of compliance with the cervical spine imaging order
This outcome corresponds to the proportion of patients for whom cervical spine imaging does not correspond to that recommended by the HAS strategy.
Measured: Day1
Secondary outcomes (2)
Level of knowledge of emergency physicians on HAS recommendations
This outcome corresponds to the percentage of physicians who provided at least 80% of responses to the questionnaire in agreement with the 2020 HAS recommendations.
Measured: Day1
Questionnaire of difficulties faced by emergency physicians in the management of whiplash injuries
This outcome corresponds to the difficulties reported by emergency physicians.
Measured: Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start14 Oct 2022
- Primary completion14 Nov 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cervical 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
- Retrospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camille NUSSBAUM, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605847
- Sponsor's protocol ID
- MINERVA
- Acronym
- MINERVA
- Status last verified
- Dec 2022
- First submitted
- 31 Oct 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cusick JF, Yoganandan N. Biomechanics of the cervical spine 4: major injuries. Clin Biomech (Bristol). 2002 Jan;17(1):1-20. doi: 10.1016/s0268-0033(01)00101-2.
PubMed 11779642Pimentel L, Diegelmann L. Evaluation and management of acute cervical spine trauma. Emerg Med Clin North Am. 2010 Nov;28(4):719-38. doi: 10.1016/j.emc.2010.07.003.
PubMed 20971389Griffith B, Bolton C, Goyal N, Brown ML, Jain R. Screening cervical spine CT in a level I trauma center: overutilization? AJR Am J Roentgenol. 2011 Aug;197(2):463-7. doi: 10.2214/AJR.10.5731.
PubMed 21785095Hoffman JR, Mower WR, Wolfson AB, Todd KH, Zucker MI. Validity of a set of clinical criteria to rule out injury to the cervical spine in patients with blunt trauma. National Emergency X-Radiography Utilization Study Group. N Engl J Med. 2000 Jul 13;343(2):94-9. doi: 10.1056/NEJM200007133430203.
PubMed 10891516
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence of Imaging Order to the 2020 French Guidelines for Patients With Cervical Spine Injury in the Emergency Setting: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05605847
- Acronym / sponsor ID
- MINERVA / MINERVA
- Conditions
- Cervical Spine Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Nov 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.
Cervical spine trauma is a frequent reason for consultation in emergency medicine. It concerns approximately 10,000 patients admitted to the emergency room each year in France. There are two types of cervical spine trauma: penetrating and non-penetrating. Non-penetrating injuries are the most frequent and can be classified according to the mechanism involved. Whiplash is the most common type of trauma in emergency medicine. The injuries associated with this type of trauma predominate in the mobile spinal segment and are most often benign: only 2 to 3% of conscious patients consulting the emergency room actually present with cervical injuries such as fractures, dislocations or unstable sprains. In emergency medicine, the paradigm is therefore to identify patients at risk of complications, minimizing the need for unnecessary and radiating imaging. Although cervical spine trauma is a frequent reason for emergency room visits, the incidence of anatomical lesions is generally low and the X-rays prescribed most often do not show any abnormality. For cervical lesion screening to be safe and effective, the screening rules must have a high sensitivity, a low negative likelihood ratio, and a low false positive rate. Two clinical prediction rules have been extensively evaluated in the literature to guide imaging for nonpenetrating cervical injuries: the National Emergency X-Radiography Utilization Study (NEXUS) rule and the Canadian C-Spine 5 rule. The NEXUS rule4 applies to any clinically stable patient (Glasgow Coma Scale 15, systolic blood pressure ≥ 90 mmHg, and respiratory rate between 10 and 24/min) presenting to the emergency department with a nonpenetrating trauma. The criteria constituting the NEXUS clinical rule are:
- Absence of tenderness on palpation of the posterior cervical midline ;
- Normal state of alertness (Glasgow Coma Scale 15);
- Absence of focal neurological deficit;
- Absence of signs of intoxication;
- Absence of distracting pain (other pain that may mask neck pain, e.g., long bone fracture).
If these 5 criteria are present, the risk of cervical spine injury is low and no imaging is recommended.
The Canadian C-Spine 5 rule applies to patients who are 16 years of age or older; conscious with a Glasgow Coma Scale of 15; stable (systolic blood pressure ≥ 90 mmHg and respiratory rate between 10 and 24/min); and have had head or neck trauma in the past 48 hours. As soon as the rules of clinical prediction do not make it possible to rule out the hypothesis of a spinal injury, the exploration of cervical trauma traditionally involves the performance of radiographic images. They must include the following incidences: face, profile and open mouth centered on the cervico-occipital hinge ("open mouth odontoid"). Nevertheless, the sensitivity of these conventional radiographs for the detection of cervical spine lesions is poor, about 50%. Thus, the use of standard radiographs is usually limited to conscious, ambulatory patients at low risk of spinal injury. Conversely, the cervical CT is the reference examination for the detection of spinal bone lesions with a sensitivity close to 100%. Its sensitivity is superior to that of radiographic images in both high-risk and low-risk patients with spinal injuries. Difficulty of access and exposure to ionizing radiation, which is lower with standard radiography, generally influence the choice of imaging in the emergency room. In December 2020, the French High Authority for Health published a sheet on the relevance of cervical imaging in the context of non-penetrating cervical trauma. This sheet proposes a practical table according to the precise clinical context of the patient as well as the best first-line imaging. These good practice recommendations were part of an approach to improve the relevance of care. Cervical spine imaging for patients admitted to the emergency department for non-penetrating cervical spine trauma was recommended in one of the following situations
- patient 65 years of age or older ;
- patient unstable or with consciousness disorders or neurological signs;
- imaging recommended by one of the following two rules: NEXUS or Canadian C-Spine;
- a history of ankylosing spine (ankylosing spondylitis, hyperostosis, etc.), even in case of "minor" trauma;
- if a cervical artery dissection is suspected. Investigator's hypothesis is that the HAS recommendations of good cervical imaging practices for non-penetrating cervical trauma are difficult to apply routinely in emergency departments for several reasons: the frequency of consultations for cervical trauma, the limited availability of emergency CT scans, and the fear of radiation and unnecessary additional costs in emergency situations. Investigators wish to determine the actual rate of application of the clinical rules recommended by the HAS in the GHPSJ emergency department and the factors predicting their non-application by the GHPSJ team of emergency physicians.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient consulting the GHPSJ emergency department for a non-penetrating cervical spine injury from 01/01/2021 to 12/31/2021
Key inclusion criteria (3 listed)
- Patient whose age is ≥ 18 years
- Patient consulting the GHPSJ emergency department for a non-penetrating cervical spine injury from 01/01/2021 to 12/31/2021
- French-speaking patient
Key exclusion criteria (4 listed)
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
- Patient objecting to the use of his data for this research
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
Proportion of patients with non-penetrating cervical trauma in the emergency department for whom there is a lack of compliance with the cervical spine imaging order
Time frame: Day1
This outcome corresponds to the proportion of patients for whom cervical spine imaging does not correspond to that recommended by the HAS strategy.
2 secondary outcomes
Level of knowledge of emergency physicians on HAS recommendations
Time frame: Day1
Questionnaire of difficulties faced by emergency physicians in the management of whiplash injuries
Time frame: Day1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Background: PubMed 11779642Cusick JF, Yoganandan N. Biomechanics of the cervical spine 4: major injuries. Clin Biomech (Bristol). 2002 Jan;17(1):1-20. doi: 10.1016/s0268-0033(01)00101-2.
- Background: PubMed 20971389Pimentel L, Diegelmann L. Evaluation and management of acute cervical spine trauma. Emerg Med Clin North Am. 2010 Nov;28(4):719-38. doi: 10.1016/j.emc.2010.07.003.
- Background: PubMed 21785095Griffith B, Bolton C, Goyal N, Brown ML, Jain R. Screening cervical spine CT in a level I trauma center: overutilization? AJR Am J Roentgenol. 2011 Aug;197(2):463-7. doi: 10.2214/AJR.10.5731.
- Background: PubMed 10891516Hoffman JR, Mower WR, Wolfson AB, Todd KH, Zucker MI. Validity of a set of clinical criteria to rule out injury to the cervical spine in patients with blunt trauma. National Emergency X-Radiography Utilization Study Group. N Engl J Med. 2000 Jul 13;343(2):94-9. doi: 10.1056/NEJM200007133430203.
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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.
Camille NUSSBAUM, MD principal investigator
Fondation Hôpital Saint-Joseph
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 Cervical Spine Injury, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 3 inclusion and 4 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 9 Dec 2022. 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 France. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with non-penetrating cervical trauma in the emergency department for whom there is a lack of compliance with the cervical spine imaging order (time frame: Day1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05605847, which also lists 4 linked publications.
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 9 Dec 2022.