EXTended pRotective Curtain Under Table to Reduce Operator RAdiation Dose in Percutaneous Coronary Procedures

Study Overview
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Brief Summary
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Radiation dose to interventional cardiologists performing transradial percutaneous coronary procedures is higher compared to those performing transfemoral exams. The radiation dose seems particularly high at pelvic level. We prepared an home-made protective extension of the leaded curtain under table that should reduce the operator exposure during interventional coronary procedures. The aim of the study is to evaluate the procedural efficacy of the protective extension on the operator radiation dose at pelvic level

Detailed Description
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Interventional cardiologists are routinely exposed to x-rays during their activity increasing the risk of deterministic and stochastic effects. Consequently all the operators should be aware of the possible risks and they should apply all efforts to reduce the radiation dose according to the As Low As Reasonably Achievable (ALARA) principle. Moreover interventional cardiologists have to utilise adequate protection devices (lead apron, protective thyroid collar, lead glasses). Operator performing transradial access procedures showed a significantly higher radiation exposure compared to those performing transfemoral interventions. So, transradial operators should use adjunctive protective shields (as leaded pelvic drapes placed on the patient abdomen) in order to reduce their radio-exposition. During transradial access a particularly high radiation exposure is observed at operator pelvic level and the use of the protective adjunctive drapes placed on the patient abdomen is only partially effective to control this exposition. Aim of our study was to evaluate the effect of a protective extension of the leaded curtain placed under the angiographic table in term of operator radiation exposure at pelvic level

Official Title
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Evaluation of a New Device Placed Under the Angiographic Table to Reduce Operator Radiation Exposure During Percutaneous Coronary Procedures Through Transradial Approach

Conditions
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Radiation, X-rays; Effects, Coronary Disease

Intervention / Treatment
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* Device: SCUT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patient undergoing percutaneous coronary procedures through transradial access Exclusion Criteria: Interventions performed through a different vascular access Procedures performed in patients with ST elevation acute myocardial infarction Haemodynamic instability Lack of written informed consent Age < 18 years old Previous coronary artery by-pass

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparison of operator radiation dose at pelvic level during percutaneous coronary procedures through transradial access with or without an extension of the leaded curtain under table
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCUT<br>Use of a Small Curtain under table (SCUT) placed under the cranial part of the angiographic table | Device: SCUT<br>* Two different home made curtains were attached to the angiographic table<br>|
| No Intervention: Control<br>Control Group without the SCUT | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operator pelvic dose | Operator radiation dose at pelvic level | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operator thorax dose | Operator radiation dose at thorax level | 24 hours | 
| Operator head dose | Operator radiation dose at head level | 24 hours | 
| Operator pelvic dose and experimental curtain utilized | Operator radiation Dose at pelvic level comparing the two different experimental leaded curtain utilized | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transradial, Coronary, X-ray, Radiation, Curtain