REDucing Unnecessary Computed Tomography Imaging for MaxillOfacial INjury

Craniocerebral Trauma Clinical Trial

— REDUCTION  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03314480
• Other study ID #: 201700304
• Status: Completed
• Start date: May 1, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: May 2022
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1126
• Est. completion date: June 1, 2021
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• consultation within 7 days of trauma

Exclusion Criteria:

• history of maxillofacial surgery

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Emergencies
• Emergency Medicine
• Image Interpretation, Computer-Assisted
• Maxillofacial Injuries
• Wounds and Injuries

Intervention

Diagnostic Test:
• Standardized physical examination
Standarized physical examination dedicated to assess a potential fracture in the maxillofacial or mandibular region.

Locations

Country	Name	City	State
Netherlands	Nij Smellinghe ziekenhuis	Drachten	Friesland
Netherlands	University Medical Center Groningen, University of Groningen	Groningen
Netherlands	Isala Diaconessenhuis	Meppel	Overijssel
Netherlands	Isala ziekenhuis	Zwolle	Overijssel

Sponsors (3)

Lead Sponsor	Collaborator
University Medical Center Groningen	Isala, Nij Smellinghe Hosptial

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CT time	Time from admission to CT scanner	Within 2 weeks from admission to the emergency department
Other	Emergency department total time of admission	Total time the patient was of admitted at the emergency department	Within 2 weeks from admission to the emergency department
Primary	Maxillofacial fracture	The presence of either a maxillofacial or mandibular fracture induced by the trauma and diagnosed using CT or orthopantomography in the emergency department.	Within 1 day, from admission to discharge from the emergency department
Secondary	Treatment outcome	The outcome of the treatment as determined by the Oral and Maxillofacial (OMF) surgeon or emergency physician classified as; Admission and direct surgical treatment; Admission following elective surgery; Discharge following elective surgery; Discharge, expectative treatment and follow-up after seven days; Discharge, conservative treatment and follow-up after seven days; Discharge, conservative treatment, no follow-up	Within 2 weeks upon admission to the emegency department