Clinical Trials Directory

Trials / Completed

CompletedNCT05833516

Hyper Adduction of Right Radial Artery/Arm vs Left Drag Over Technique

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

Status
Completed
Phase
Study type
Observational
Enrollment
534 (actual)
Sponsor
Maimonides Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTCardiac CatheterizationThe cardiac catheterization is an invasive procedure in which right or left radial artery of patient will be accessed to obtain cardiac angiogram. The study participants are both operators and patients by obtaining the amount of radiation they both were exposed in these two different arm techniques. The patient will have to do nothing more than following the existing standard protocols which are followed nationwide. As, the radiation exposure to patients are already measured in the software itself. The operators however would be wearing radiation badges in 4 different anatomic locations to record radiation data for study.

Timeline

Start date
2022-11-10
Primary completion
2024-02-23
Completion
2024-02-23
First posted
2023-04-27
Last updated
2025-03-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05833516. Inclusion in this directory is not an endorsement.