Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05347290
Other study ID # 21-1302
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 9, 2022
Est. completion date December 9, 2022

Study information

Verified date February 2023
Source Northwell Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Previous studies have documented that orthopedic injuries and musculoskeletal pain are a likely result of wearing heavy leaded aprons that are designed to shield interventionalists and laboratory staff from radiation. A large, multicenter study found that interventional laboratory employees reported a 67% increase in the prevalence of musculoskeletal pain. Two Society of Cardiovascular Angiography and Intervention (SCAI) surveys were performed a decade apart in 2004 and 2014 which both showed similar results on the orthopedic complications on the operators who wear leaded apron protection. The surveys revealed a 60% incidence of orthopedic issues and operators who have been operating greater than 20 years in the Cath Lab compared to a 2.3% incidence of chronic spine problems in the general population. Interestingly, of the operators who had been in practice less than 5 years, 26% already had orthopedic complaints. The study also revealed that over a third of those surveyed had already had to take spine related periods of absence from the catheterization lab. Though in recent years focus on individual radiation attenuation technologies that support both attenuation and orthopedic safety have evolved, the emphasis has been on the operator. A solution has not existed to address radiation attenuation and orthopedic safety for the entire scrubbed interventional team with one system. To address the challenge of radiation protection in this environment without the burden of wearing a heavy lead apron, Rampart IC, M1128 was created. Rampart IC, M1128 is a fully adjustable and portable system that provides radiation protection for operators and their team without having to wear a lead apron. This study will have three randomization arms, each arm requiring 21 procedures for a total of 63 total procedures. Randomization stratification will be based on procedure, not individual subject. Each enrolled subject may be involved in more than one procedure/case. Computer software will be utilized to randomize procedures in a 1:1:1 ratio to either lead apron with ancillary shield, Rampart IC, M1128, or lead apron with the Rampart IC, M1128. Real-time dosimeters will be placed on interventional staff's left temple, shoulder, and hip in order to measure radiation attenuation.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date December 9, 2022
Est. primary completion date December 9, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Pregnancy - Unwilling to consent to the study protocol.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Rampart IC, M1128
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.
Lead Apron and Ancillary Shield
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.
Rampart IC, M1128 and Lead Apron
Participating providers will use both the lead apron and the Rampart Shield. Radiation exposure will be measured using real-time dosimeters.

Locations

Country Name City State
United States Lenox Hill Hospital New York New York

Sponsors (1)

Lead Sponsor Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in radiation attenuation Change in radiation attenuation as detected by dosimeter readings for staff assigned to each randomization stratification. 90 days
See also
  Status Clinical Trial Phase
Completed NCT03649451 - Reference Dose Levels During Fluoroscopically Guided Procedures in Operating Rooms
Completed NCT03305978 - Pulmonary Nodule Detection: Comparison of an Ultra Low Dose vs Standard Scan. N/A
Recruiting NCT04139096 - Genetic Susceptibility to Radiation Induced Thyroid Cancer
Completed NCT01430975 - Prospective Evaluation of Strontium in Patients After CardioGen-82 PET MPI Scanning at Two Clinical Sites N/A
Completed NCT01424774 - Prospective Evaluation of Strontium in Patients After CardioGen-82 PET MPI Scanning N/A
Completed NCT00378053 - A Prospective Study of Radiation Exposure to Surgeons N/A
Recruiting NCT05561439 - Individual Dosimetric Monitoring of Workers During Interventional Radiology and Cardiology Procedures for Cardiologists and Radiologists in France
Completed NCT04078165 - Suspended Personal Protection System Versus Conventional Protection (Aka Zero-Gravity vs Shield and Apron) N/A
Recruiting NCT04694391 - Genomic Study of Relapse Esophageal Cancer After Radiotherapy
Not yet recruiting NCT04403815 - Radiation Exposure During Coronary Procedures According to Vascular Access
Recruiting NCT04285944 - Operator Radiation Protection During Cardiac Catheterization Using Mavig X-ray Protective Drapes®. N/A
Completed NCT04363190 - Genomic Instability in Vascular Surgeons
Completed NCT04404257 - Reduce Radiation Exposure in Fluoroscopic Interventions Evaluation N/A
Recruiting NCT04678258 - Zero Fluoroscopy Voltage Guided vs. Linear CTI Ablation N/A
Recruiting NCT03386500 - Safety Study of BMX-001 (Radio-protector) in Patients With Newly Diagnosed Anal Cancer Phase 1/Phase 2
Recruiting NCT05833516 - Hyper Adduction of Right Radial Artery/Arm vs Left Drag Over Technique
Recruiting NCT03946280 - Utility of 3D Navigation to Reduce Ionizing Radiation in Common Flutter Ablation. Study of Personnel and Patient Dosimetry N/A
Completed NCT03985488 - Radiation Exposure Assessment in Fluoroscopy
Completed NCT03605030 - Reducing Radiation Exposure to Operators During Invasive Cardiac Procedures N/A
Recruiting NCT02689908 - Individualized Radiation Dose Control N/A

External Links