Comparison of Two Protocols of Optimization of X Ray Radiations in Pediatric Interventional Neuroradiology

Not Applicable

Terminated

• Conditions: Occlusion or Malformation of a Cerebral Vessel
• Interventions: Device: protocol of optimization ALARA; Device: protocol of optimization Philips

• Registration Number: NCT02008305
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

Interventional Neuroradiology replaces surgery. This technology requires various exposition to X rays : number of X rays photographs, radioscopy, distance between patient and detector, speed of acquisition of X-rays photographs, high tension and intensity.

The manipulator must find the right balance between quality of photographs and dose delivered to the patient (optimization).

Children are particularly exposed to these risks of irradiation (sensitivity to X-rays and long life expectancy with risks. So, it is fundamental to optimize the dose delivered during the procedures.

The investigators propose to analyse a study comparing two protocols of optimization of doses. The investigators' hypothesis is that the protocol experimented in this trial allows less radiation of the children, compared to the usual protocol.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-06
• Study First Posted: 2013-12-11
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-08
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• malformation or occlusion of a cerebral vessel requiring interventional Neuroradiology

Exclusion Criteria

• opposition ot the parent(s) to the participation of their child in the trial and/or no social security.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
protocol of optimization ALARA	protocol of optimization ALARA	protocol of optimization ALARA protocol of optimization of doses
protocol of opimization Philips	protocol of optimization Philips	protocol of optimization Philips usual protocol of optimization of doses

Primary Outcome Measures

Name	Time	Method
Comparison of the average dose per child, according to the protocol	maximum one day per patient

Secondary Outcome Measures

Name	Time	Method
number of X-rays photographs according to the protocol, quality of photographs according to the protocol,	maximum one day per patient

Trial Locations

Locations (1)

Fondation ophtalmique Adolphe de Rothschild; 🇫🇷 Paris, France