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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03259126
Acronym
EXTRA-RAD
Enrollment
157
Registered
2017-08-23
Start date
2017-08-07
Completion date
2018-08-13
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Disease, Radiation, X-rays; Effects

Keywords

Transradial, Coronary, X-ray, Radiation, Curtain

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

Interventions

DEVICESCUT

Two different home made curtains were attached to the angiographic table

Sponsors

Ospedale Sandro Pertini, Roma
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Operator pelvic dose24 hoursOperator radiation dose at pelvic level

Secondary

MeasureTime frameDescription
Operator thorax dose24 hoursOperator radiation dose at thorax level
Operator head dose24 hoursOperator radiation dose at head level
Operator pelvic dose and experimental curtain utilized24 hoursOperator radiation Dose at pelvic level comparing the two different experimental leaded curtain utilized

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026