Craniocerebral Trauma Clinical Trial
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
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04741334 -
Mild Head Injury, Antiplatelets, and Anticoagulants
|
||
Terminated |
NCT01430988 -
Observational Study of the BrainScope® Ahead™ M-100 in UK Emergency Department Patients With Head Injury
|
N/A | |
Completed |
NCT00860210 -
Pilot Study Assessing the Feasibility of Treating Foot Drop With the Neurostep™ System.
|
Phase 1 | |
Completed |
NCT00409058 -
Teen Online Problem Solving (TOPS) - An Online Intervention Following TBI
|
N/A | |
Completed |
NCT00251108 -
Fitness Training After Traumatic Brain Injury
|
N/A | |
Completed |
NCT02881957 -
Hypovitaminosis D in Neurocritical Patients
|
Phase 2/Phase 3 | |
Completed |
NCT02368366 -
Comparative Effectiveness of Family Problem-Solving Therapy (F-PST) for Adolescent TBI
|
N/A | |
Completed |
NCT02819778 -
Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury
|
N/A | |
Completed |
NCT01886222 -
Randomized Controlled Trial of Long-term Mild Hypothermia for Severe Traumatic Brain Injury
|
N/A | |
Recruiting |
NCT06015451 -
Exercise in Postconcussion Symptoms and Posttraumatic Headache
|
N/A | |
Completed |
NCT05292690 -
An Assistive Powered Wheelchair: Stage 2 Trial
|
||
Terminated |
NCT01961804 -
PREVACT : Preventive REversal of Vitamine K Antagonist in Minor Craniocerebral Trauma
|
Phase 3 | |
Completed |
NCT00005004 -
Brain Processing of Language Meanings
|
N/A | |
Recruiting |
NCT05306951 -
Correct Timing of Head Imaging in Trauma
|
||
Completed |
NCT05891522 -
Pilot Study of the Use of a Portable Cranial Scanner in Intensive Care for Cerebro-injured Patients
|
N/A | |
Completed |
NCT02776462 -
Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients
|
||
Completed |
NCT00200135 -
Financial and Clinical Impact of Repeal of the Pennsylvania Motorcycle Helmet Law
|
N/A | |
Completed |
NCT00534157 -
Study of Eye Pressure as a Predictor of Intracranial Pressure in the Acutely Head-Injured Population
|
N/A | |
Recruiting |
NCT01633268 -
Estimating Brain Biomechanics Using MRI
|
||
Completed |
NCT02442882 -
The Acute Effect of Boxing on Balance, Neuropsychological, and Visual Functions
|
N/A |