Dosimeter Location in Pain Physicians

Dosimeter Location and Measured Effective Radiation Dose in Pain Management Physicians

The primary objective is to determine if there is a significant difference in radiation readings between dosimeters worn on the chest versus the hand of interventional pain management physicians and elucidate which dosimeter had higher readings.

The secondary objective is to track incidences of physician glove breaches in both groups to assess if wearing hand dosimeters is associated with an increased risk of this event.

Study Overview

• Status: Completed
• Conditions: RAD
• Intervention / Treatment: Device: Hand Dosimeters; Device: Standard Practice

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Physicians actively performing fluoroscopy procedures at the Comprehensive Pain Center.

Exclusion Criteria:

• Those that do not want to participate in the quality improvement project.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chest and Hand Dosimeters; Subjects will wear both chest and hand dosimeters during all radiation procedures performed at the Comprehensive Pain Center during the study period.	Device: Hand Dosimeters; Participants were assigned to wear hand dosimeters in addition to the standard chest dosimeter worn by all participants
Active Comparator: Chest Dosimeter; Subjects will wear only a chest dosimeter during all radiation procedures performed at the Comprehensive Pain Center during the study period.	Device: Standard Practice; Participants only wore standard chest dosimeters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation Readings	Dose equivalent in mREM for each dosimeter that is worn by the subject.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Glove Breach Events	Number of intra-procedure glove breaches	6 months

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Sandy Christiansen, MD, Associate professor

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2022
• Primary Completion (Actual): April 21, 2023
• Study Completion (Actual): April 21, 2023

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Radiation; Physician; Pain Medicine; Dosimeter
• Other Study ID Numbers: STUDY00024903

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual data will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No