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Dose reduction in whole-body computed tomography of multiple injuries (DoReMI): protocol for a prospective cohort study.

Abstract：

BACKGROUND: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. METHODS/DESIGN:Prospective 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. DISCUSSION:Although 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 REGISTRATION:Current Controlled Trials ISRCTN74557102.

journal_name

Scand J Trauma Resusc Emerg Med

journal_title

Scandinavian journal of trauma, resuscitation and emergency medicine

authors

Stengel D,Ottersbach C,Kahl T,Nikulka C,Güthoff C,Hartel T,Hünnebeck S,Ekkernkamp A,Mutze S

doi

10.1186/1757-7241-22-15

subject

Has Abstract

pub_date

2014-03-03 00:00:00

pages

issn

1757-7241

pii

1757-7241-22-15

journal_volume

pub_type

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Dose reduction in whole-body computed tomography of multiple injuries (DoReMI): protocol for a prospective cohort study.