Clinical trial NCT03314480: REDucing Unnecessary Computed Tomography Imaging for MaxillOfacial INjury
Official title: A Novel Clinical Decision Aid for the Diagnostic Management of Maxillofacial Trauma: the REDUCTION Trial - REDucing Unnecessary Computed Tomography Imaging for MaxillOfacial INjury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maxillofacial Injuries
Image Interpretation, Computer-Assisted
Craniocerebral Trauma
Emergency Medicine
Keywords: Multidetector Computed Tomography
Cone Beam Computed Tomography
Maxillofacial fractures
zygomaticomaxillary fractures
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Isala
name: Nij Smellinghe Hosptial
First posted: 2017-10-19
Enrollment: 1126
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a maxillofacial trauma admitted to the emergency department of the cooperating hospitals

Brief summary: The aim is to prospectively assess the association between clinical parameters and the presence of maxillofacial fractures in trauma patients admitted to the emergency department. Our hypothesis is that a clinical decision aid of critical parameters reduces unnecessary produced CT scans in maxillofacial trauma patients.

Detailed description: The REDUCTION trial is a prospective multicentre cohort study conducted at the level I emergency departments of the University Medical Center Groningen, Isala hospital (Zwolle, The Netherlands) and the level II trauma center Nij Smellinghe hospital (Drachten, The Netherlands). The increased availability of Computed Tomography (CT) in the emergency department is leading to an overuse for patients with suspected maxillofacial injury. The use of a clinical decision aid could lead to more expedient use of diagnostic imaging within this population of patients. Therefore, all maxillofacial trauma patients admitted to the emergency department are included in this trial if the consultation is within 7 days after trauma. Both maxillofacial trauma patients admitted to CT scan and patients without a radiological confirmed diagnosis are included. The research protocol was approved by the institutional review board of the University Medical Center Groningen (Groningen, The Netherlands). Informed consent was waived as patients are treated according to the standards of care. Upon admission, each patient with maxillofacial injury will be allocated as a midfacial or mandibular trauma. During physical examination, either by the emergency physician or surgical resident, a pre-defined selection of clinical parameters will be assessed focussing on the assessment of potential presence of fractures in the maxillofacial region. The standardization of this examination will be ensured using a pocket map and easy accessible online instructional video's. The clinical parameters, fracture likelihood and physical examination findings will be structurally reported in electronic health record software using a smart tool dedicated for maxillofacial injury. Data regarding patient demographics, mechanism of injury, concomitant injury, diagnostic outcome and radiation dose parameters will be derived from the medical records.

Eligibility criteria: Inclusion Criteria:

* consultation within 7 days of trauma

Exclusion Criteria:

* history of maxillofacial surgery

Primary outcomes:
measure: Maxillofacial fracture
timeFrame: Within 1 day, from admission to discharge from the emergency department
Secondary outcomes:
measure: Treatment outcome
timeFrame: Within 2 weeks upon admission to the emegency department
Other outcomes:
measure: CT time
timeFrame: Within 2 weeks from admission to the emergency department
measure: Emergency department total time of admission
timeFrame: Within 2 weeks from admission to the emergency department
Locations:
city: Drachten
country: Netherlands
facility: Nij Smellinghe ziekenhuis
state: Friesland
city: Meppel
country: Netherlands
facility: Isala Diaconessenhuis
state: Overijssel
city: Zwolle
country: Netherlands
facility: Isala ziekenhuis
state: Overijssel
city: Groningen
country: Netherlands
facility: University Medical Center Groningen, University of Groningen
Study officials:
affiliation: University of Groningen
name: Fred KL Spijkervet, DMD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rozema R, Moumni ME, de Vries GT, Spijkervet FKL, Verbeek R, Kleinbergen JYJ, Bens BWJ, Doff MHJ, van Minnen B; REDUCTION study group. A clinical decision aid for patients with suspected midfacial and mandibular fractures (the REDUCTION-I study): a prospective multicentre cohort study. Eur J Trauma Emerg Surg. 2022 Oct;48(5):4243-4254. doi: 10.1007/s00068-022-01968-1. Epub 2022 Apr 16.
citation: Rozema R, El Moumni M, de Vries GT, Spijkervet FKL, Verbeek R, Kleinbergen JYJ, Bens BWJ, Doff MHJ, van Minnen B; REDUCTION study group. A clinical decision aid to discern patients without and with midfacial and mandibular fractures that require treatment (the REDUCTION-II study): a prospective multicentre cohort study. Eur J Trauma Emerg Surg. 2022 Aug;48(4):2547-2558. doi: 10.1007/s00068-022-01892-4. Epub 2022 Feb 24.