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

Primary Purpose

Radiation, X-rays; Effects, Coronary Disease

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
SCUT
Sponsored by
Ospedale Sandro Pertini, Roma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiation focused on measuring Transradial, Coronary, X-ray, Radiation, Curtain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ospedale Sandro Pertini

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SCUT

Control

Arm Description

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

Control Group without the SCUT

Outcomes

Primary Outcome Measures

Operator pelvic dose
Operator radiation dose at pelvic level

Secondary Outcome Measures

Operator thorax dose
Operator radiation dose at thorax level
Operator head dose
Operator radiation dose at head level
Operator pelvic dose and experimental curtain utilized
Operator radiation Dose at pelvic level comparing the two different experimental leaded curtain utilized

Full Information

First Posted
August 16, 2017
Last Updated
August 17, 2018
Sponsor
Ospedale Sandro Pertini, Roma
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1. Study Identification

Unique Protocol Identification Number
NCT03259126
Brief Title
EXTended pRotective Curtain Under Table to Reduce Operator RAdiation Dose in Percutaneous Coronary Procedures
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 7, 2017 (Actual)
Primary Completion Date
August 13, 2018 (Actual)
Study Completion Date
August 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Sandro Pertini, Roma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation, X-rays; Effects, Coronary Disease
Keywords
Transradial, Coronary, X-ray, Radiation, Curtain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SCUT
Arm Type
Experimental
Arm Description
Use of a "Small Curtain under table" (SCUT) placed under the cranial part of the angiographic table
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control Group without the SCUT
Intervention Type
Device
Intervention Name(s)
SCUT
Intervention Description
Two different home made curtains were attached to the angiographic table
Primary Outcome Measure Information:
Title
Operator pelvic dose
Description
Operator radiation dose at pelvic level
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Operator thorax dose
Description
Operator radiation dose at thorax level
Time Frame
24 hours
Title
Operator head dose
Description
Operator radiation dose at head level
Time Frame
24 hours
Title
Operator pelvic dose and experimental curtain utilized
Description
Operator radiation Dose at pelvic level comparing the two different experimental leaded curtain utilized
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Sciahbasi, MD, PhD
Organizational Affiliation
Ospeadale Sandro Pertini ASL RM2
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Sandro Pertini
City
Rome
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30732471
Citation
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.
Results Reference
derived

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

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