Abstract
BackgroundSingle-pass, contrast-enhanced whole body multidetector computed tomography (MDCT) emerged as the diagnostic standard for evaluating patients with major trauma. Modern iterative image algorithms showed high image quality at a much lower radiation dose in the non-trauma setting. This study aims at investigating whether the radiation dose can safely be reduced in trauma patients without compromising the diagnostic accuracy and image quality.Methods/DesignProspective observational study with two consecutive cohorts of patients.Setting: A high-volume, academic, supra-regional trauma centre in Germany.Study population: Consecutive male and female patients who 1. had been exposed to a high-velocity trauma mechanism, 2. present with clinical evidence or high suspicion of multiple trauma (predicted Injury Severity Score [ISS] ≥16) and 3. are scheduled for primary MDCT based on the decision of the trauma leader on call.Imaging protocols: In a before/after design, a consecutive series of 500 patients will undergo single-pass, whole-body 128-row multi-detector computed tomography (MDCT) with a standard, as low as possible radiation dose. This will be followed by a consecutive series of 500 patients undergoing an approved ultra-low dose MDCT protocol using an image processing algorithm.Data: Routine administrative data and electronic patient records, as well as digital images stored in a picture archiving and communications system will serve as the primary data source. The protocol was approved by the institutional review board.Main outcomes: (1) incidence of delayed diagnoses, (2) diagnostic accuracy, as correlated to the reference standard of a synopsis of all subsequent clinical, imaging, surgical and autopsy findings, (3) patients’ safety, (4) radiation exposure (e.g. effective dose), (5) subjective image quality (assessed independently radiologists and trauma surgeons on a 100-mm visual analogue scale), (6) objective image quality (e.g., contrast-to-noise ratio).Analysis: Multivariate regression will be employed to adjust and correct the findings for time and cohort effects. An exploratory interim analysis halfway after introduction of low-dose MDCT will be conducted to assess whether this protocol is clearly inferior or superior to the current standard.DiscussionAlthough non-experimental, this study will generate first large-scale data on the utility of imaging-enhancing algorithms in whole-body MDCT for major blunt trauma.Trial registrationCurrent Controlled Trials ISRCTN74557102.
Highlights
Single-pass, contrast-enhanced whole body multidetector computed tomography (MDCT) emerged as the diagnostic standard for evaluating patients with major trauma
The primary hypothesis read as: In patients with multiple trauma scheduled for singlepass, contrast-enhanced whole-body 128-row MDCT, the iDose algorithm will generate a subjective image quality rated on a visual analogue scale (0 – 100 mm) which is not inferior to standard image production and processing
The investigator should maintain all source data together with related study documentation for the maximum period of time permitted by the hospital, institution or private practice, but not less than that minimally prescribed by the local authorities after the clinical part of the study has been completed. This is the first study which assesses the potential value of a dose-reducing MDCT regimen in patients with multiple and severe trauma
Summary
Single-pass, contrast-enhanced whole body multidetector computed tomography (MDCT) emerged as the diagnostic standard for evaluating patients with major trauma. Modern iterative image algorithms showed high image quality at a much lower radiation dose in the non-trauma setting. This study aims at investigating whether the radiation dose can safely be reduced in trauma patients without compromising the diagnostic accuracy and image quality. Immediately life-threatening injuries and sources of bleeding must be identified (or excluded) with high accuracy [9,10]. Apart from damage-control resuscitation and surgery, the introduction of contrastenhanced, whole-body, multi-detector computed tomography may be regarded as one of the most important interventions which changed the face of trauma care during the past decade [11,12,13,14]
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