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OpenTrials
Completed

NCT Number: NCT03259126

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Sandro Pertini

Rome, Lazio, 00168, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SCUT

Device

Two different home made curtains were attached to the angiographic table

Primary outcomes

  1. Operator pelvic dose

    Time frame: 24 hours

    Operator radiation dose at pelvic level

Secondary outcomes

  1. Operator thorax dose

    Time frame: 24 hours

    Operator radiation dose at thorax level

  2. Operator head dose

    Time frame: 24 hours

    Operator radiation dose at head level

  3. Operator pelvic dose and experimental curtain utilized

    Time frame: 24 hours

    Operator radiation Dose at pelvic level comparing the two different experimental leaded curtain utilized

Sponsors and collaborators

Lead sponsor

Ospedale Sandro Pertini, Roma

Other

Registry information

Official study title

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

Acronym: EXTRA-RAD

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 23, 2017
Registry last updated
Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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