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Clinical Trials/NCT05833516
NCT05833516CompletedNot Applicable

Operator Radiation Exposure in Hyper Adduction of Right Radial Artery/Arm vs Left Arm Drag Over Technique.

Maimonides Medical Center1 site in 1 country534 target enrollmentStarted: November 10, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
534
Locations
1
Primary Endpoint
Normalized Dose

Study Overview

Brief Summary

Several studies have shown that operator exposure via left transradial catheterization has yielded less operator exposure compared to standard right transradial procedure. However, in light of new data, the investigators hypothesize a hyperadducted right arm during right transradial cardiac catheterization will yield comparable, or the same operator radiation exposure.

Detailed Description

Few studies have examined operator's radiation exposure tor transradial cardiac catheterization between the left vs right radial artery approach. In light of recent studies (Schiabasi et al) demonstrating adduction of the right arm yields lower operator exposure than that of the right arm positioned away from the body to the operators. The investigators seek to examine if hyper adduction of the right arm yields similar operator exposure to that of the left radial approach.

Historically the left radial approach has been more favorable in terms of operator exposure. However, the primary access site for interventional cardiologists has been the right radial artery due to cardiac catheterization laboratories set up for operators to work on the right side of the table. This study seeks to find if a hyperadducted right arm yields less, more, or similar radiation exposure to the operator in cardiac catheterization laboratory than the left radial artery approach.

This study's primary outcome is to measure the radiation exposure to the primary operator during diagnostic cardiac catheterization at four different anatomical locations (these are Maimonides Medical Center employees -attending physicians in the catheterization lab). Study's secondary outcomes aim to measure Dose Area Product, mGy of radiation dose, & contrast administration to the patients undergoing the procedure and presence/absence of subclavian artery tortuosity which are recorded automatically and regardless during the diagnostic procedure.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • All the Cardiac catheterization laboratory physician operators who consent to participate in the study
  • Patients of any sex and gender.
  • Age > 18 years old.
  • Patients undergoing diagnostic coronary angiogram from in-patient and out-patient settings

Exclusion Criteria

  • History of prior CABG (Coronary Artery Bypass Surgery). CABG patients will be excluded due to inherent increased fluoroscopic time (finding grafts).
  • Patients undergoing elective PCI (Percutaneous Coronary Intervention)

Outcomes

Primary Outcomes

Normalized Dose

Time Frame: During Cardiac Catheterization

The second primary endpoint is Normalized dose, measured by dividing cumulative dose by dose area product (CD/DAP) and entered into query sheet then logged into an Excel spreadsheet.

Operator radiation exposure

Time Frame: During Cardiac Catheterization

The primary operators will wear real time radiation dose monitoring at the left eye, right eye, thorax and abdomen level. At the end of each diagnostic procedure the cumulative radiation dose (measured in µSv) data at each level will be collected

Secondary Outcomes

  • Flouroscopy time(During Cardiac Catheterization)
  • Dose Area product (DAP)(During Cardiac Catheterization)
  • mGy(During Cardiac Catheterization)
  • Subclavian tortuosity (Yes/no)(During Cardiac Catheterization)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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