REDucing Unnecessary Computed Tomography Imaging for MaxillOfacial INjury

Completed

• Conditions: Maxillofacial Injuries; Craniocerebral Trauma; Emergency Medicine; Image Interpretation, Computer-Assisted
• Interventions: Diagnostic Test: Standardized physical examination

• Registration Number: NCT03314480
• Lead Sponsor: University Medical Center Groningen

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-10-18
• Study First Posted: 2017-10-19
• Study Start: 2018-05-01
• Primary Completion: 2019-09-30
• Study Completion: 2021-06-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-20
• Last Update Posted: 2022-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1126

Inclusion Criteria

• consultation within 7 days of trauma

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Exclusion Criteria

• history of maxillofacial surgery

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Midfacial fracture suspected patients	Standardized physical examination	Patients who are suspected of maxillofacial fracture
Mandibular fracture suspected patients	Standardized physical examination	Patients who are suspected of a mandibular fracture

Primary Outcome Measures

Name	Time	Method
Maxillofacial fracture	Within 1 day, from admission to discharge from the emergency department	The presence of either a maxillofacial or mandibular fracture induced by the trauma and diagnosed using CT or orthopantomography in the emergency department.

Secondary Outcome Measures

Name	Time	Method
Treatment outcome	Within 2 weeks upon admission to the emegency department	The 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

Trial Locations

Locations (4)

Isala ziekenhuis; 🇳🇱 Zwolle, Overijssel, Netherlands

University Medical Center Groningen, University of Groningen; 🇳🇱 Groningen, Netherlands

Isala Diaconessenhuis; 🇳🇱 Meppel, Overijssel, Netherlands

Nij Smellinghe ziekenhuis; 🇳🇱 Drachten, Friesland, Netherlands