Trials / Completed
CompletedNCT03314480
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,126 (actual)
- Sponsor
- University Medical Center Groningen · Academic / Other
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Maxillofacial Injuries
- Image Interpretation, Computer-Assisted
- Craniocerebral Trauma
- Emergency Medicine
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Standardized physical examination | Standarized physical examination dedicated to assess a potential fracture in the maxillofacial or mandibular region. |
Timeline
- Start date
- 2018-05-01
- Primary completion
- 2019-09-30
- Completion
- 2021-06-01
- First posted
- 2017-10-19
- Last updated
- 2022-05-23
Locations
4 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT03314480. Inclusion in this directory is not an endorsement.