Skip to main content
OpenTrials
Completed

NCT Number: NCT03314480

REDucing Unnecessary Computed Tomography Imaging for MaxillOfacial INjury

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Maxillofacial Injuries Craniocerebral Trauma Emergency Medicine Facial Injuries Image Interpretation, Computer-Assisted Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Isala Diaconessenhuis, Meppel, Overijssel, Netherlands

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • consultation within 7 days of trauma

Exclusion criteria

  • history of maxillofacial surgery

Treatment and study plan

Standardized physical examination

Diagnostic Test

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

Primary outcomes

  1. Maxillofacial fracture

    Time frame: 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 outcomes

  1. Treatment outcome

    Time frame: 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;

    • 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

Other outcomes

  1. CT time

    Time frame: Within 2 weeks from admission to the emergency department

    Time from admission to CT scanner

  2. Emergency department total time of admission

    Time frame: Within 2 weeks from admission to the emergency department

    Total time the patient was of admitted at the emergency department

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Isala
  • Nij Smellinghe Hosptial

Registry information

Official study title

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

Acronym: REDUCTION

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Oct 19, 2017
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.