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REDucing Unnecessary Computed Tomography Imaging for MaxillOfacial INjury

A Novel Clinical Decision Aid for the Diagnostic Management of Maxillofacial Trauma: the REDUCTION Trial - REDucing Unnecessary Computed Tomography Imaging for MaxillOfacial INjury

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03314480
Acronym
REDUCTION
Enrollment
1126
Registered
2017-10-19
Start date
2018-05-01
Completion date
2021-06-01
Last updated
2022-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniocerebral Trauma, Emergency Medicine, Image Interpretation, Computer-Assisted, Maxillofacial Injuries

Keywords

Multidetector Computed Tomography, Cone Beam Computed Tomography, Maxillofacial fractures, zygomaticomaxillary fractures

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.

Interventions

DIAGNOSTIC_TESTStandardized physical examination

Standarized physical examination dedicated to assess a potential fracture in the maxillofacial or mandibular region.

Sponsors

Isala
CollaboratorOTHER
Nij Smellinghe Hosptial
CollaboratorOTHER
University Medical Center Groningen
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* consultation within 7 days of trauma

Exclusion criteria

* history of maxillofacial surgery

Design outcomes

Primary

MeasureTime frameDescription
Maxillofacial fractureWithin 1 day, from admission to discharge from the emergency departmentThe presence of either a maxillofacial or mandibular fracture induced by the trauma and diagnosed using CT or orthopantomography in the emergency department.

Secondary

MeasureTime frameDescription
Treatment outcomeWithin 2 weeks upon admission to the emegency departmentThe outcome of the treatment as determined by the Oral and Maxillofacial (OMF) surgeon or emergency physician classified as; 1. Admission and direct surgical treatment 2. Admission following elective surgery 3. Discharge following elective surgery 4. Discharge, expectative treatment and follow-up after seven days 5. Discharge, conservative treatment and follow-up after seven days 6. Discharge, conservative treatment, no follow-up

Other

MeasureTime frameDescription
CT timeWithin 2 weeks from admission to the emergency departmentTime from admission to CT scanner
Emergency department total time of admissionWithin 2 weeks from admission to the emergency departmentTotal time the patient was of admitted at the emergency department

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026