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Suspended Personal Protection System Versus Conventional Protection (Aka Zero-Gravity vs Shield and Apron)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04078165
Recruitment Status : Not yet recruiting
First Posted : September 4, 2019
Last Update Posted : September 4, 2019
Information provided by (Responsible Party):
Maarit Venermo, Helsinki University Central Hospital

Brief Summary:
This trial investigates operator radiation doses when performing standardized procedures using two different means of radiation protection, namely conventional lead shield and apron versus suspended protection system (Zero-Gravity, ZG). The performed procedure is standard endovascular aortic repair (EVAR). The hypothesis is that ZG offers superior protection for the operator.

Condition or disease Intervention/treatment Phase
Radiation Exposure Device: Zero-Gravity Device: Conventional radiation protection Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Zero-Gravity
In this group, the operator uses the Zero-Gravity protection system
Device: Zero-Gravity
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

Primary Outcome Measures :
  1. Radiation exposure [ Time Frame: During operations ]
    Radiation dosages in multiple dosimeters on operator

Secondary Outcome Measures :
  1. Fluoroscopy duration [ Time Frame: During operation ]
    Duration of fluoroscopy in seconds

  2. Fluoroscopy dose area product (DAP) [ Time Frame: During operation ]
    Patient radiation exposure

  3. Entrance skin air KERMA [ Time Frame: During operation ]
    Patient radiation exposure

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • all patients eligible for standard EVAR at Helsinki University Hospital

Exclusion Criteria:

  • any additional interventions such as embolization, recanalization, screw fixation

Information from the National Library of Medicine

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 identifier (NCT number): NCT04078165

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Contact: Pekka Aho, M.D., Ph.D. +094711
Contact: Maarit Venermo, M.D., Ph.D. +094711

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Helsinki University Hospital Not yet recruiting
Helsinki, Finland
Contact: Pekka Aho    +094711   
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         
Sponsors and Collaborators
Helsinki University Central Hospital
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Study Director: Maarit Venermo, MD, PhD Helsinki University

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Responsible Party: Maarit Venermo, Professor, Helsinki University Central Hospital Identifier: NCT04078165     History of Changes
Other Study ID Numbers: 2019/09/01
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maarit Venermo, Helsinki University Central Hospital:
radiation protection
endovascular surgery