Clinical trial NCT03259126: EXTended pRotective Curtain Under Table to Reduce Operator RAdiation Dose in Percutaneous Coronary Procedures
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
Overall status: COMPLETED
Phase: NA
Conditions: Radiation
X-rays; Effects
Coronary Disease
Keywords: Transradial
Coronary
X-ray
Radiation
Curtain
Lead sponsor: Ospedale Sandro Pertini, Roma
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Operator pelvic dose
timeFrame: 24 hours
Secondary outcomes:
measure: Operator thorax dose
timeFrame: 24 hours
measure: Operator head dose
timeFrame: 24 hours
measure: Operator pelvic dose and experimental curtain utilized
timeFrame: 24 hours
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Ospedale Sandro Pertini
state: Lazio
Study officials:
affiliation: Ospeadale Sandro Pertini ASL RM2
name: Alessandro Sciahbasi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.