Comparative Study of Calculating the X-ray Dose to the Skin of the Patient Exposed

Completed

• Conditions: Measure of the X-ray Dose

• Registration Number: NCT04048694
• Lead Sponsor: University Hospital, Brest

Brief Summary

The main objective is to estimate the precision of the calculation by the software DoseMap ® towards the in vivo measure by gafchromic movie.

Detailed Description

The procedures of Interventional Cardiology are realized under exposure in the X-rays which can be sometimes important for the patient according to the nature of the procedure.

The estimation of the dose in the skin following a procedure of interventional cardiology is difficult. The knowledge of this dose allows to anticipate the appearance of determinist effects, and so to activate a dermatological follow-up of the exposed patient in case of overtaking of a dose threshold. Unfortunately, it is impossible to measure it directly and the thresholds of exposures are fixed from the measure of the kerma in the air accumulated at the exit of the tube with X-ray, what remains very indistinct.

Since a few years the manufacturers propose tools allowing an estimation of the dose the skin of the patient. The DoseMap software ® allows to consider this dose from the data of exposure supplied by the system. To do it, it uses a modelling simplified of the patient to feign the deposit of dose in the latter.

It seems to us interesting to verify the precision of this simulation by comparing it with a measure of the in vivo dose.

Study Timeline

• Study Start: 2016-04-11
• Study First Submitted: 2016-09-08
• Primary Completion: 2016-10-27
• Study Completion: 2016-10-27
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-06
• Last Update Submitted: 2019-08-06
• Study First Posted: 2019-08-07
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Procedure of Interventional Cardiology potentially more irradiant (angioplasty of the circumflex artery , or of several vessels)
• Body mass index > 25
• Collection of the Non-opposition of the patient

Exclusion Criteria

• Diagnostic coronarography,
• Emergency procedures,
• Minor patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference between the calculation by the software and the measurement by the dosimetry film	6 months

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France