Dosimeter Location in Pain Physicians

NCT06309407 | Completed Results FDA Device

• 1 other identifier: STUDY00024903
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

RAD

Keywords

Dosimeter; Radiation; Pain Medicine; Physician

Outcome Measures

Primary Outcomes (1)

• Radiation Readings

  Dose equivalent in mREM for each dosimeter that is worn by the subject.

  6 months

Secondary Outcomes (1)

• Total Number of Glove Breach Events

  6 months

Study Arms (2)

Chest and Hand Dosimeters

EXPERIMENTAL

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

Chest Dosimeter

ACTIVE COMPARATOR

Subjects will wear only a chest dosimeter during all radiation procedures performed at the Comprehensive Pain Center during the study period.

Device: Standard Practice

Interventions

Hand Dosimeters DEVICE

Participants were assigned to wear hand dosimeters in addition to the standard chest dosimeter worn by all participants

Chest and Hand Dosimeters

Standard Practice DEVICE

Participants only wore standard chest dosimeters

Chest Dosimeter

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Limitations and Caveats

Small sample size that is not powered to detect a difference.

Results Point of Contact

• Title: Dr. Sandy Christiansen
• Organization: Oregon Health and Science University

chrissan@ohsu.edu

2038092318

Study Officials

• Sandy Christiansen, MD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants were randomized to wear either chest dosimeters only or chest and hand dosimeters for the duration of the study in order to measure differences in radiation readings by each dosimeter location.

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 13, 2024
• Study Start: September 23, 2022
• Primary Completion: April 21, 2023
• Study Completion: April 21, 2023
• Last Updated: August 13, 2024
• Results First Posted: August 13, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)