Suspended Personal Protection System Versus Conventional Protection (Aka Zero-Gravity vs Shield and Apron)
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|ClinicalTrials.gov Identifier: NCT04078165|
Recruitment Status : Not yet recruiting
First Posted : September 4, 2019
Last Update Posted : September 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Radiation Exposure||Device: Zero-Gravity Device: Conventional radiation protection||Not Applicable|
Endovascular aneurysm repair (EVAR) is less invasive than open surgery, yet the procedure causes sustained radiation exposure to the operator and has a potential risk of radiation-induced skin damage and later malignancy. The deterministic (threshold limited) adverse effects of radiation have been known since the invention of the X-ray in 1895, but the stochastic (non-threshold limited) adverse effects are not so apparent and thus need constant refinement. Diligent usage of radiation protection and abidance to ALARA (As Low As Reasonably Achievable) principles minimizes cumulative radiation exposure.
The lens of the human eye is very sensitive to radiation and cataract formation has been reported among medical interventional practitioners. Previous research into differences between conventional protection (apron and shields) and suspended personal protection (Zero Gravity, ZG) claims superior protection, especially to the lens, while using a suspended personal protection system. Ancillary lead glasses may be needed to fully protect the eyes. In other studies randomization of methods was deemed irrelevant due to expected dramatic differences between conventional and suspended protection systems. In addition standardization of procedures was lacking, because of cohort matching difficulties. The methods of measuring scattered radiation varies among previous studies and we have found the evaluation methods flawed.
The aim of this research is to evaluate the total radiation exposure to the interventionalist and assistant during infrarenal abdominal aortic aneurysm stent-grafting, while using either conventional protection (lead apron and shield) or a suspended personal protection system (Zero-Gravity, ZG). The ZG system consists of a lead shield that is suspended from the ceiling or a separate hanger that permits freedom of motion of the operator, and with no weight supported by the operator.
The total radiation doses have seen considerate reduction already in Helsinki, Finland and lower doses may influence the efficacy of the ZG system. Improper usage of the ZG protection gear as a whole can lead to inefficient protection.
The operator's subjective ergonomic feel and experience will be evaluated with a postoperative questionnaire.
The patients will be randomized into two groups: one where the operator will be using conventional protection (shield and apron) and one where the operator will be using the ZG system. The data will be collected during a four month period, which includes approximately 50 standardized EVAR operations.
Dosimeters will be used to collect the data during the procedures and are placed in various anatomical regions (eye, chest, leg, stomach, control outside protection). The exposure dosage to the eye is measured with EYE-D (Eye lens TLD dosimeter) and other measurements are done using DIS-1 dosimeters. Other data collected includes total fluoroscopy duration, total dose area product (DAP), entrance skin air KERMA (ESAK), and body mass index.
The anonymity and rights of participants will be protected. The health of patients is of uttermost importance and there is no difference in care received.
The planning and design has started since May 2019. Data collection will commence after dosimeter testing in September 2019 and last until December 2019. After data analysis the results will be disseminated in Spring 2020. Literature review will take place parallel to the research.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Suspended Personal Protection System Versus Conventional Protection (Aka Zero-Gravity vs Shield and Apron)|
|Estimated Study Start Date :||September 2, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||February 28, 2020|
In this group, the operator uses the Zero-Gravity protection system
Free-floating, suspended personal radiation protection
Active Comparator: Conventional
In this group, the operator uses conventional radiation protection
Device: Conventional radiation protection
Standard lead shields and aprons
- Radiation exposure [ Time Frame: During operations ]Radiation dosages in multiple dosimeters on operator
- Fluoroscopy duration [ Time Frame: During operation ]Duration of fluoroscopy in seconds
- Fluoroscopy dose area product (DAP) [ Time Frame: During operation ]Patient radiation exposure
- Entrance skin air KERMA [ Time Frame: During operation ]Patient radiation exposure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04078165
|Contact: Pekka Aho, M.D., Ph.D.||+firstname.lastname@example.org|
|Contact: Maarit Venermo, M.D., Ph.D.||+email@example.com|
|Helsinki University Hospital||Not yet recruiting|
|Contact: Pekka Aho +094711 firstname.lastname@example.org|
|Sub-Investigator: Simo Toiviainen, med student|
|Sub-Investigator: Ivika Heinola, MD, PhD|
|Sub-Investigator: Pirkka Vikatmaa, MD, PhD|
|Sub-Investigator: Patrick Björkman, MD, PhD|
|Sub-Investigator: Maarit Venermo, MD, PhD|
|Principal Investigator: Pekka Aho, MD, PhD|
|Sub-Investigator: Sani Laukontaus, MD, PhD|
|Study Director:||Maarit Venermo, MD, PhD||Helsinki University|