REDucing Unnecessary Computed Tomography Imaging for MaxillOfacial INjury

NCT ID: NCT03314480

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1126 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2021-06-01

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.

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Midfacial fracture suspected patients

Patients who are suspected of maxillofacial fracture

Standardized physical examination

Intervention Type: DIAGNOSTIC_TEST

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

Mandibular fracture suspected patients

Patients who are suspected of a mandibular fracture

Standardized physical examination

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Standardized physical examination

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• consultation within 7 days of trauma

Exclusion Criteria

• history of maxillofacial surgery

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Isala

OTHER

Sponsor Role: collaborator

Nij Smellinghe Hosptial

OTHER

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Romke Rozema

BSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fred KL Spijkervet, DMD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Groningen

Locations

Isala Diaconessenhuis

Meppel, Overijssel, Netherlands

Isala ziekenhuis

Zwolle, Overijssel, Netherlands

Nij Smellinghe ziekenhuis

Drachten, Provincie Friesland, Netherlands

University Medical Center Groningen, University of Groningen

Groningen, , Netherlands

Countries

Netherlands

References

Rozema R, Moumni ME, de Vries GT, Spijkervet FKL, Verbeek R, Kleinbergen JYJ, Bens BWJ, Doff MHJ, van Minnen B; REDUCTION study group. A clinical decision aid for patients with suspected midfacial and mandibular fractures (the REDUCTION-I study): a prospective multicentre cohort study. Eur J Trauma Emerg Surg. 2022 Oct;48(5):4243-4254. doi: 10.1007/s00068-022-01968-1. Epub 2022 Apr 16.

Reference Type: DERIVED

PMID: 35430710 (View on PubMed)

Rozema R, El Moumni M, de Vries GT, Spijkervet FKL, Verbeek R, Kleinbergen JYJ, Bens BWJ, Doff MHJ, van Minnen B; REDUCTION study group. A clinical decision aid to discern patients without and with midfacial and mandibular fractures that require treatment (the REDUCTION-II study): a prospective multicentre cohort study. Eur J Trauma Emerg Surg. 2022 Aug;48(4):2547-2558. doi: 10.1007/s00068-022-01892-4. Epub 2022 Feb 24.

Reference Type: DERIVED

PMID: 35211773 (View on PubMed)

Other Identifiers

201700304

Identifier Type: -

Identifier Source: org_study_id