Comparison Of Effective Radiation Shielding Between Rampart IC, M1128 Shield vs Conventional Apron And Shields In Clinical Interventional Procedures

NCT05347290 | Completed DMC FDA Device

• 1 other identifier: 21-1302
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Previous studies have documented that orthopedic injuries and musculoskeletal pain are a likely result of wearing heavy leaded aprons. This single-center, randomized 1-3 month clinical study compares conventional lead aprons and ancillary shields to the Rampart IC, M1128 radiation protection system in order to improve radiation safety with minimal orthopedic strain by using the RAMPART device. There will be three study arms, each arm requiring 21 procedures for a total of 63 total procedures, Each procedure will be randomized, instead of individual subjects. Each enrolled subject may be involved in more than one procedure/case. Randomization stratification will be 1:1:1 to either Rampart shield only, lead apron and ancillary shield, or lead apron and Rampart Shield. Real-time dosimeters will be used in each procedure to measure radiation attenuation.

Conditions

Radiation Exposure

Keywords

radiation; radiation exposure; interventional cardiology; cardiac catherization laboratory; cardiac cath lab; lead apron; RAMPART Shield; radiation protection

Outcome Measures

Primary Outcomes (1)

• Change in radiation attenuation

  Change in radiation attenuation as detected by dosimeter readings for staff assigned to each randomization stratification.

  90 days

Study Arms (3)

Lead Apron + Rampart IC, M1128

EXPERIMENTAL

Consented providers will perform catherization procedures utilizing both lead apron and Rampart system. Radiation will be measured by dosimeters worn by the providers.

Device: Rampart IC, M1128 and Lead Apron

Rampart M1128 IC, Only

EXPERIMENTAL

Consented providers will perform catherization procedures utilizing only the Rampart system. Radiation will be measured by dosimeters worn by the providers.

Device: Rampart IC, M1128

Lead Apron Only

ACTIVE COMPARATOR

This is the control group. Consented providers will perform catherization procedures utilizing only the lead apron and ancillary shields (lead skirt, vest, thyroid collar (all at least 0.5mm Pb) with use of under table lead per lab operating policy and mobile suspended lead-acrylic shield and lead glasses). Radiation will be measured by dosimeters worn by the providers.

Device: Lead Apron and Ancillary Shield

Interventions

Rampart IC, M1128 DEVICE

Rampart IC, M1128 aims to address the challenge of radiation protection in the cardiac catheterization laboratory without the burden of wearing a heavy lead apron. Rampart M1128 is a compactly designed, portable, fully adjustable system that provides radiation protection for interventionalists and their technicians. It has independently adjustable flexible panels, allowing interventionalists multiple vascular access points, including right radial, bi-lateral femoral, and bi-lateral pedal. Participants in this arm will conduct catherization procedures using only the Rampart System, and radiation exposure will be measured using real-time dosimeters.

Also known as: Rampart Shield, Rampart, Rampart System, Rampart M1128

Rampart M1128 IC, Only

Lead Apron and Ancillary Shield DEVICE

Participating providers in this arm will use conventional skirt and vest, thyroid collar, and 100% use of 2 types of ancillary shields. Most wrap-around skirts and vests were (0.25-0.5 mm) Pb. Thyroid shields were 0.5 mm Pb equivalent. Under the table lead x 2. Radiation exposure will be measured using real-time dosimeters.

Also known as: LAS, Lead Apron

Lead Apron Only

Rampart IC, M1128 and Lead Apron DEVICE

Participating providers will use both the lead apron and the Rampart Shield. Radiation exposure will be measured using real-time dosimeters.

Lead Apron + Rampart IC, M1128

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants \> 18 years of age.
• Interventional cardiology staff at Lenox Hill Hospital that are scheduled to work in Room C of the cardiac catheterization laboratory.

You may not qualify if:

• Pregnancy
• Unwilling to consent to the study protocol.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Lenox Hill Hospital

New York, New York, 10075, United States

Location

Related Publications (9)

• Andreassi MG, Piccaluga E, Guagliumi G, Del Greco M, Gaita F, Picano E. Occupational Health Risks in Cardiac Catheterization Laboratory Workers. Circ Cardiovasc Interv. 2016 Apr;9(4):e003273. doi: 10.1161/CIRCINTERVENTIONS.115.003273.

  PMID: 27072525 BACKGROUND

• Zakeri F, Hirobe T, Akbari Noghabi K. Biological effects of low-dose ionizing radiation exposure on interventional cardiologists. Occup Med (Lond). 2010 Sep;60(6):464-9. doi: 10.1093/occmed/kqq062. Epub 2010 Jun 2.

  PMID: 20519631 BACKGROUND

• Klein LW, Miller DL, Balter S, Laskey W, Haines D, Norbash A, Mauro MA, Goldstein JA. Occupational health hazards in the interventional laboratory: time for a safer environment. Radiology. 2009 Feb;250(2):538-44. doi: 10.1148/radiol.2502082558.

  PMID: 19188321 BACKGROUND

• Picano E, Vano E. The radiation issue in cardiology: the time for action is now. Cardiovasc Ultrasound. 2011 Nov 21;9:35. doi: 10.1186/1476-7120-9-35.

  PMID: 22104562 BACKGROUND

• Orme NM, Rihal CS, Gulati R, Holmes DR Jr, Lennon RJ, Lewis BR, McPhail IR, Thielen KR, Pislaru SV, Sandhu GS, Singh M. Occupational health hazards of working in the interventional laboratory: a multisite case control study of physicians and allied staff. J Am Coll Cardiol. 2015 Mar 3;65(8):820-826. doi: 10.1016/j.jacc.2014.11.056.

  PMID: 25720626 BACKGROUND

• Goldstein JA, Balter S, Cowley M, Hodgson J, Klein LW; Interventional Committee of the Society of Cardiovascular Interventions. Occupational hazards of interventional cardiologists: prevalence of orthopedic health problems in contemporary practice. Catheter Cardiovasc Interv. 2004 Dec;63(4):407-11. doi: 10.1002/ccd.20201.

  PMID: 15558765 BACKGROUND

• Klein LW, Tra Y, Garratt KN, Powell W, Lopez-Cruz G, Chambers C, Goldstein JA; Society for Cardiovascular Angiography and Interventions. Occupational health hazards of interventional cardiologists in the current decade: Results of the 2014 SCAI membership survey. Catheter Cardiovasc Interv. 2015 Nov;86(5):913-24. doi: 10.1002/ccd.25927. Epub 2015 Mar 24.

  PMID: 25810341 BACKGROUND

• Hirshfeld JW Jr, Balter S, Brinker JA, Kern MJ, Klein LW, Lindsay BD, Tommaso CL, Tracy CM, Wagner LK, Creager MA, Elnicki M, Lorell BH, Rodgers GP, Weitz HH; American College of Cardiology Foundation; American Heart Association/; HRS; SCAI; American College of Physicians Task Force on Clinical Competence and Training. ACCF/AHA/HRS/SCAI clinical competence statement on physician knowledge to optimize patient safety and image quality in fluoroscopically guided invasive cardiovascular procedures: a report of the American College of Cardiology Foundation/American Heart Association/American College of Physicians Task Force on Clinical Competence and Training. Circulation. 2005 Feb 1;111(4):511-32. doi: 10.1161/01.CIR.0000157946.29224.5D. No abstract available.

  PMID: 15687141 BACKGROUND

• Ross AM, Segal J, Borenstein D, Jenkins E, Cho S. Prevalence of spinal disc disease among interventional cardiologists. Am J Cardiol. 1997 Jan 1;79(1):68-70. doi: 10.1016/s0002-9149(96)00678-9.

  PMID: 9024739 BACKGROUND

Related Links

• Rampart IC, M1128 website

Study Officials

• Varinder P Singh, M.D.

  Senior Vice President, Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Vice President, Cardiology

Model Details: This single center randomized 1-3 month clinical study compares conventional lead aprons and ancillary shields to the Rampart IC, M1128 fully configurable, portable, floor supported system that provides radiation protection and orthopedic safety for operators and the scrubbed interventional team members. There will be three study arms, each arm requiring 21 procedures for a total of 63 total procedures. Each enrolled subject may be involved in more than one procedure/case. For all arms, subjects will wear real-time dosimeters on their right temple, shoulder, and hip, and values will be collected post-procedure.

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 26, 2022
• Study Start: March 9, 2022
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2022
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)