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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hand Dosimeters | Device | Participants were assigned to wear hand dosimeters in addition to the standard chest dosimeter worn by all participants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiation Readings | Dose equivalent in mREM for each dosimeter that is worn by the subject. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Glove Breach Events | Number of intra-procedure glove breaches | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandy Christiansen, MD | Associate Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
Individual data will not be shared with other researchers.
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All enrolled participants were randomized. There were no participants excluded before assignment to groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Hand Dosimeters: Participants were assigned to wear hand dosimeters in addition to the standard chest dosimeter worn by all participants |
| FG001 | Chest Dosimeter | Subjects will wear only a chest dosimeter during all radiation procedures performed at the Comprehensive Pain Center during the study period. Standard Practice: Participants only wore standard chest dosimeters |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Hand Dosimeters: Participants were assigned to wear hand dosimeters in addition to the standard chest dosimeter worn by all participants |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Radiation Readings | Dose equivalent in mREM for each dosimeter that is worn by the subject. | In the chest and hand dosimeter group, for each participant one chest and one hand dosimeter recording was analyzed. In the chest group, one chest dosimeter recordings was analyzed. | Posted | Mean | 95% Confidence Interval | mREM | 6 months | Dosimeters | Dosimeters |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Hand Dosimeters: Participants were assigned to wear hand dosimeters in addition to the standard chest dosimeter worn by all participants |
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Small sample size that is not powered to detect a difference.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sandy Christiansen | Oregon Health and Science University | 2038092318 | chrissan@ohsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 7, 2024 | May 7, 2024 | Prot_SAP_000.pdf |
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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.
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| Standard Practice | Device | Participants only wore standard chest dosimeters |
|
| Chest Dosimeter |
Subjects will wear only a chest dosimeter during all radiation procedures performed at the Comprehensive Pain Center during the study period. Standard Practice: Participants only wore standard chest dosimeters |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Subjects will wear only a chest dosimeter during all radiation procedures performed at the Comprehensive Pain Center during the study period. Standard Practice: Participants only wore standard chest dosimeters |
|
|
| Secondary | Total Number of Glove Breach Events | Number of intra-procedure glove breaches | Posted | Number | Number of Glove Breach Events | 6 months |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Chest Dosimeter | Subjects will wear only a chest dosimeter during all radiation procedures performed at the Comprehensive Pain Center during the study period. Standard Practice: Participants only wore standard chest dosimeters | 0 | 5 | 0 | 5 | 0 | 5 |
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