EXTended pRotective Curtain Under Table to Reduce Operato... | NCT03259126

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

NCT03259126

Sponsor

Ospedale Sandro Pertini, Roma

Status

Completed

Last Update Posted

Aug 20, 2018Actual

Enrollment

157Actual

Phase

Not Applicable

Conditions

Radiation
X-rays; Effects
Coronary Disease

Interventions

SCUT

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 7, 2017Actual

Primary Completion Date

Aug 13, 2018Actual

Completion Date

Aug 13, 2018Actual

First Submitted Date

Aug 16, 2017

First Submission Date that Met QC Criteria

Aug 22, 2017

First Posted Date

Aug 23, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2018

Last Update Posted Date

Aug 20, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alessandro Sciahbasi, MD, MD, PhD, Ospedale Sandro Pertini, RomaPrincipal Investigator

Lead Sponsor

Ospedale Sandro Pertini, RomaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

157Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SCUT	Experimental	Use of a "Small Curtain under table" (SCUT) placed under the cranial part of the angiographic table	Device: SCUT
Control	No Intervention	Control Group without the SCUT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SCUT	Device	Two different home made curtains were attached to the angiographic table	SCUT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Operator pelvic dose	Operator radiation dose at pelvic level	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Operator thorax dose	Operator radiation dose at thorax level	24 hours
Operator head dose	Operator radiation dose at head level	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alessandro Sciahbasi, MD, PhD	Ospeadale Sandro Pertini ASL RM2	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ospedale Sandro Pertini		Rome	Lazio	00168	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30732471	Derived	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.

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases