EffectivenesS of Additional X-ray PRotection dEviceS in Reducing Scattered Radiation in Radial interventiOn

Exposure of Member of Staff to Medical Diagnostic X-Ray Clinical Trial

— ESPRESSO  

Official title:

Wirksamkeit Additiver Strahlenschutzvorrichtungen Zwecks Reduzierung Der Ionisierenden Streustrahlung im Herzkatheterlabor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03634657
• Other study ID #: ESPRESSO
• Status: Completed
• Phase: N/A
• Start date: August 16, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: October 2020
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the radiation exposure of scattered radiation for the interventionalist during coronary angiography using different X-ray protection materials, namely, an X-ray Screen without additional X-ray protection, an X-ray Screen with additional protective strips and an X-ray Screen with additional protective strips AND protective patient cut-outs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: October 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• indication for coronary angiography

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Exposure of Member of Staff to Medical Diagnostic X-Ray

Intervention

Radiation:
• Plain X-ray protection shield
Coronary angiography with mere X-ray protection shield
• Protection shield & X-ray protective strips
Coronary angiography with X-ray protection shield & X-ray protective strips
• Protection shield & protective strips & patient cut-outs
Coronary angiography with X-ray protection shield & X-ray protective strips & X-ray protection patient cut-outs

Locations

Country	Name	City	State
Germany	University Medical Center Mainz	Mainz	Rheinland Pfalz

Sponsors (1)

Lead Sponsor	Collaborator
Tommaso Gori

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operator dose	Dose of radiation measured	Duration of coronary angiography of individuel patient, varies between approximately 5 minutes of radiation (easy access, exclusion coronary heart disease) and app. 3 hours (difficult and complex percutaneous coronary intervention).