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

Coronary Disease Clinical Trial

— EXTRA-RAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03259126
• Other study ID #: Pertini05
• Status: Completed
• Phase: N/A
• Start date: August 7, 2017
• Est. completion date: August 13, 2018

Study information

• Verified date: August 2018
• Source: Ospedale Sandro Pertini, Roma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: August 13, 2018
• Est. primary completion date: August 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Radiation
• X-rays; Effects

Intervention

Device:
• SCUT
Two different home made curtains were attached to the angiographic table

Locations

Country	Name	City	State
Italy	Ospedale Sandro Pertini	Rome	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Sandro Pertini, Roma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operator pelvic dose	Operator radiation dose at pelvic level	24 hours
Secondary	Operator thorax dose	Operator radiation dose at thorax level	24 hours
Secondary	Operator head dose	Operator radiation dose at head level	24 hours
Secondary	Operator pelvic dose and experimental curtain utilized	Operator radiation Dose at pelvic level comparing the two different experimental leaded curtain utilized	24 hours