EXTended pRotective Curtain Under Table to Reduce Operator RAdiation Dose in Percutaneous Coronary Procedures (EXTRA-RAD)

Ospedale Sandro Pertini, Roma

Status: Completed

Conditions: Radiation; Coronary Disease; X-rays; Effects

Treatments: Device: SCUT

Study type: Interventional

Funder types: Other

Identifiers

NCT03259126

Pertini05

Details and patient eligibility

About

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

Full 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

Enrollment: 157 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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157 participants in 2 patient groups

SCUT

Experimental group

Description:

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

Treatment:

Device: SCUT

Control

No Intervention group

Description:

Control Group without the SCUT