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

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

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

Study Overview

• Status: Completed
• Conditions: Coronary Disease; Radiation; X-rays; Effects
• Intervention / Treatment: Device: SCUT

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 Type: Interventional
• Enrollment (Actual): 157
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Ospedale Sandro Pertini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ospedale Sandro Pertini, Roma
• Investigators: Principal Investigator: Alessandro Sciahbasi, MD, PhD, Ospeadale Sandro Pertini ASL RM2

Publications and helpful links

General Publications

• Sciahbasi A, Sarandrea A, Rigattieri S, Patrizi R, Cera M, Di Russo C, Zezza L, Fedele S, Ferraiuolo G. Extended Protective Shield Under Table to Reduce Operator Radiation Dose in Percutaneous Coronary Procedures. Circ Cardiovasc Interv. 2019 Feb;12(2):e007586. doi: 10.1161/CIRCINTERVENTIONS.118.007586.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2017
• Primary Completion (Actual): August 13, 2018
• Study Completion (Actual): August 13, 2018

Study Registration Dates

• First Submitted: August 16, 2017
• First Submitted That Met QC Criteria: August 22, 2017
• First Posted (Actual): August 23, 2017

Study Record Updates

• Last Update Posted (Actual): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 17, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Coronary; Radiation; X-ray; Transradial; Curtain
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease
• Other Study ID Numbers: Pertini05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No