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

Not Applicable

Completed

• Conditions: Coronary Disease; X-rays; Effects; Radiation
• Interventions: Device: SCUT

• Registration Number: NCT03259126
• Lead Sponsor: Ospedale Sandro Pertini, Roma

Brief Summary

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

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

Study Timeline

• Study Start: 2017-08-07
• Study First Submitted: 2017-08-16
• Study First Submitted QC: 2017-08-22
• Study First Posted: 2017-08-23
• Status Verified: 2018-08
• Primary Completion: 2018-08-13
• Study Completion: 2018-08-13
• Last Update Submitted: 2018-08-17
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

Inclusion Criteria

all patient undergoing percutaneous coronary procedures through transradial access

Exclusion Criteria

1. Interventions performed through a different vascular access
2. Procedures performed in patients with ST elevation acute myocardial infarction
3. Haemodynamic instability
4. Lack of written informed consent
5. Age < 18 years old
6. Previous coronary artery by-pass

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCUT	SCUT	Use of a "Small Curtain under table" (SCUT) placed under the cranial part of the angiographic table

Primary Outcome Measures

Name	Time	Method
Operator pelvic dose	24 hours	Operator radiation dose at pelvic level

Secondary Outcome Measures

Name	Time	Method
Operator pelvic dose and experimental curtain utilized	24 hours	Operator radiation Dose at pelvic level comparing the two different experimental leaded curtain utilized
Operator thorax dose	24 hours	Operator radiation dose at thorax level
Operator head dose	24 hours	Operator radiation dose at head level

Trial Locations

Locations (1)

Ospedale Sandro Pertini; 🇮🇹 Rome, Lazio, Italy