RADIATION PROTECTion With a Pelvic Lead Shield and a Radi... | NCT02128035

NCT02128035

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
Project Number 12-520	Other Identifier	Hamilton Health Sciences Research Ethics Board

Status Module

Name	Class
McMaster University	OTHER
Population Health Research Institute	OTHER

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Without Lead Shield	No Intervention	All routine measures to reduce radiation exposure (including lead aprons, lead collar, lead lenses, movable ceiling suspended lead shield with a long lead skirt attached to its lower margin) will be used as done routinely and will be left to the operators' discretion. The LEAD SHIELD will not be used in this group. Interventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures.
With Lead Shield	Experimental	All routine measures to reduce radiation exposure (including lead aprons, lead collar, lead lenses, movable ceiling suspended lead shield with a long lead skirt attached to its lower margin) will be used as done routinely and will be left to the operators' discretion. In this group, a LEAD SHIELD will be used. The Pelvic lead shield will be draped on patient from umbilicus to knees. Interventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures.	Procedure: With Lead Shield

Interventions

Name	Type	Description	Arm Group Labels	Other Names
With Lead Shield	Procedure	A pelvic lead shield will be draped on patient from umbilicus to knees. Interventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total Radiation Dose	The total radiation dose that the interventional cardiologist got exposed to as read by dosimeters (µSv) at left breast. The difference between both groups in radiation dose that the interventional cardiologist got exposed to divided by Air Kerma (µSv/mGy). For the radiation protection cap, the primary outcome is the difference between total radiation dose as measured by two dosimeters (µSv) at left temporal region of the head of the interventional cardiologist (one on the outside of the radiation protection cap and the other one on the inside of the cap).	Duration of Procedure (an expected average of 30 minutes)

Secondary Outcomes

Measure	Description	Time Frame
Radiation Exposure Dose per minute	The difference between both groups in radiation exposure dose per minute (µSv /min) at left breast and left temporal region.	Duration of Procedure (an expected average of 30 minutes)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Sanjit S Jolly, MD	Hamilton Health Sciences, McMaster University	Principal Investigator
Ashraf Al Azzoni, MD	Hamilton Health Sciences Corporation	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hamilton Health Sciences		Hamilton	Ontario	L8L2X2	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26253734	Derived	Alazzoni A, Gordon CL, Syed J, Natarajan MK, Rokoss M, Schwalm JD, Mehta SR, Sheth T, Valettas N, Velianou J, Pandie S, Al Khdair D, Tsang M, Meeks B, Colbran K, Waller E, Fu Lee S, Marsden T, Jolly SS. Randomized Controlled Trial of Radiation Protection With a Patient Lead Shield and a Novel, Nonlead Surgical Cap for Operators Performing Coronary Angiography or Intervention. Circ Cardiovasc Interv. 2015 Aug;8(8):e002384. doi: 10.1161/CIRCINTERVENTIONS.115.002384.

Condition Browse Module