Dataset Information

Effectiveness of additional X-ray protection devices in reducing Scattered radiation in radial interventions: protocol of the ESPRESSO randomised trial.

ABSTRACT: BACKGROUND:A number of devices have been developed to minimise operator radiation exposure in the setting of cardiac catheterisation. The effectiveness of these devices has traditionally been explored in transfemoral coronary procedures; however, less is known for the transradial approach. We set out to examine the impact of three different radiation protection devices in a real-world setting. METHODS AND DESIGN:Consecutive coronary diagnostic and intervention procedures are randomised in a 1:1:1 ratio to a shield-only protection (shield group), shield and overlapping 0.5?mm Pb panel curtain (curtain group) or shield, curtain and additional 75×40?cm, 0.5?mm Pb drape placed across the waist of the patient (drape group).The primary outcome is the difference in relative exposure of the primary operator among groups. Relative exposure is defined as the ratio between operator's exposure (E in ?Sv) and patient exposure (dose area product in cGy·cm2). ETHICS AND DISSEMINATION:The protocol complies with good clinical practice and the ethical principles described in the Declaration of Helsinki and is approved by the local ethics committee. The results of the trial will be published as original article(s) in medical journals and/or as presentation at congresses. TRIAL REGISTRATION NUMBER:NCT03634657.

SUBMITTER: Anadol R

PROVIDER: S-EPMC6615829 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Effectiveness of additional X-ray protection devices in reducing Scattered radiation in radial interventions: protocol of the ESPRESSO randomised trial.

Anadol Remzi R Brandt Moritz M Merz Nico N Knorr Maike M Ahoopai Majid M Geyer Martin M Krompiec Damian D Wenzel Phillip P Münzel Thomas T Gori Tommaso T

BMJ open 20190703 7

<h4>Background</h4>A number of devices have been developed to minimise operator radiation exposure in the setting of cardiac catheterisation. The effectiveness of these devices has traditionally been explored in transfemoral coronary procedures; however, less is known for the transradial approach. We set out to examine the impact of three different radiation protection devices in a real-world setting.<h4>Methods and design</h4>Consecutive coronary diagnostic and intervention procedures are rando ...[more]

PMID: 31272982

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Project description:BackgroundConflicting reports in the literature have raised the question whether radial extracorporeal shock wave therapy (rESWT) devices and vibrating massage devices have similar energy signatures and, hence, cause similar bioeffects in treated tissues.Methods and findingsWe used laser fiber optic probe hydrophone (FOPH) measurements, high-speed imaging and x-ray film analysis to compare fundamental elements of the energy signatures of two rESWT devices (Swiss DolorClast; Electro Medical Systems, Nyon, Switzerland; D-Actor 200; Storz Medical, Tägerwillen, Switzerland) and a vibrating massage device (Vibracare; G5/General Physiotherapy, Inc., Earth City, MO, USA). To assert potential bioeffects of these treatment modalities we investigated the influence of rESWT and vibrating massage devices on locomotion ability of Caenorhabditis elegans (C. elegans) worms.ResultsFOPH measurements demonstrated that both rESWT devices generated acoustic waves with comparable pressure and energy flux density. Furthermore, both rESWT devices generated cavitation as evidenced by high-speed imaging and caused mechanical damage on the surface of x-ray film. The vibrating massage device did not show any of these characteristics. Moreover, locomotion ability of C. elegans was statistically significantly impaired after exposure to radial extracorporeal shock waves but was unaffected after exposure of worms to the vibrating massage device.ConclusionsThe results of the present study indicate that both energy signature and bioeffects of rESWT devices are fundamentally different from those of vibrating massage devices.Clinical relevancePrior ESWT studies have shown that tissues treated with sufficient quantities of acoustic sound waves undergo cavitation build-up, mechanotransduction, and ultimately, a biological alteration that "kick-starts" the healing response. Due to their different treatment indications and contra-indications rESWT devices cannot be equated to vibrating massage devices and should be used with due caution in clinical practice.

Dataset Information

Effectiveness of additional X-ray protection devices in reducing Scattered radiation in radial interventions: protocol of the ESPRESSO randomised trial.

Publications

Effectiveness of additional X-ray protection devices in reducing Scattered radiation in radial interventions: protocol of the ESPRESSO randomised trial.

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