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

Not Applicable

Completed

• Conditions: Radiation Exposure
• Interventions: Device: Rampart IC, M1128 and Lead Apron; Device: Rampart IC, M1128; Device: Lead Apron and Ancillary Shield

• Registration Number: NCT05347290
• Lead Sponsor: Northwell Health

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.

Detailed 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.

Study Timeline

• Study Start: 2022-03-09
• Study First Submitted: 2022-03-31
• Study First Submitted QC: 2022-04-20
• Study First Posted: 2022-04-26
• Primary Completion: 2022-12-09
• Study Completion: 2022-12-09
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lead Apron + Rampart IC, M1128	Rampart IC, M1128 and Lead Apron	Consented providers will perform catherization procedures utilizing both lead apron and Rampart system. Radiation will be measured by dosimeters worn by the providers.
Rampart M1128 IC, Only	Rampart IC, M1128	Consented providers will perform catherization procedures utilizing only the Rampart system. Radiation will be measured by dosimeters worn by the providers.
Lead Apron Only	Lead Apron and Ancillary Shield	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.

Primary Outcome Measures

Name	Time	Method
Change in radiation attenuation	90 days	Change in radiation attenuation as detected by dosimeter readings for staff assigned to each randomization stratification.

Trial Locations

Locations (1)

Lenox Hill Hospital; 🇺🇸 New York, New York, United States