Occupational Exposure to Radiation
Conditions
Keywords
Occupational Exposure to Radiation
Brief summary
The primary objective of the present trial is to compare the radiation attenuation provided by XPF caps (0.5mm lead-equivalent and 0.3mm lead-equivalent) to the standard protection (fabric cap, basically no protection) as measured in % radiation attenuation) during 150 days of fluoroscopy guided cardiology interventions. The second objective is to compare the operator comfort (rated on a visual analog scale) of wearing the XPF protection caps compared to the standard fabric caps.
Detailed description
The primary objective of the present trial is to compare the radiation attenuation provided by XPF caps (0.5mm lead-equivalent and 0.3mm lead-equivalent) to the standard protection (fabric cap, basically no protection) as measured in % radiation attenuation) during 150 days of fluoroscopy guided cardiology interventions. The second objective is to compare the operator comfort (rated on a visual analog scale) of wearing the XPF protection caps compared to the standard fabric caps. For more information please contact Dr. Raul Herrera, MD, Director Baptist Cardiac and Vascular Institute Baptist Hospital of Miami.
Interventions
DEVICE0.5mm XPF cap
Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions. XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.
DEVICE0.3mm XPF cap
Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions. XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.
DEVICEStandard cap
Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
Sponsors
Baptist Health South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Interventional Cardiologist practicing in Baptist Cardiac & Vascular Institute * cardiac procedure requiring C-arm fluoroscopy
Exclusion criteria
* Interventional Neuroradiologists and Interventional Radiologists will not be included in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiation Attenuation in Percentage (%) | 1 day | The null hypothesis is that the XPF 0.5mm lead-equivalent caps attenuation is equal to the XPF 0.3mm lead-equivalent and standard cap attenuations. The alternative hypothesis is that the XPF 0.5mm lead-equivalent cap attenuation is superior or inferior to the XPF 0.3mm lead-equivalent and standard cap attenuations. The groups will be compared separately and a pooled analysis, comparing XPF 0.5mm and 0.3mm combined vs. standard is also planned.The radiation protection (radiation dose reduction) expressed as a percentage was calculated by subtracting radiation measured underneath the cap from radiation measured outside the cap and then dividing this difference by the product of radiation measured outside the cap multiplied by 100. |
| Absolute Radiation Exposure Outside of Cap | 1 day | The cumulative radiation doses were defined as the summation of all correspondent equivalent doses measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operator Comfort Assessment | 1 day per participant, a total of 197 operator days | After completion of the last procedure on each day, the operators were asked to rate the comfort of wearing the cap on a scale from 0 (unbearably heavy, badly fitting) to 100 (very light, well fitting). |
| Operator Comfort Assessment Based on Weight | 1 day per participant, a total of 197 operator days | After completion of the last procedure on each day, the caps worn by the operators were weighed to assess comfort of wearing the standard cap, XPF 0.3mm and XPF 0.5mm caps. The operators were asked to rate the comfort of wearing the cap on a scale from 0 (unbearably heavy, badly fitting) to 100 (very light, well fitting). |
Countries
United States
Participant flow
Recruitment details
Patients presenting to the Miami Cardiac and Vascular Institute for Imaging Study/Procedure.
Pre-assignment details
Voluntary patient participation. PI responsible for patient selection.
Participants by arm
| Arm | Count |
|---|---|
| Standard Cap Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
Standard cap: Interventionalist wear a standard fabric cap during fluoroscopy guided interventions. | 59 |
| 0.3mm XPF Cap Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.
0.3mm XPF cap: Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.
XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material. | 74 |
| 0.5mm XPF Cap Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.
0.5mm XPF cap: Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.
XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material. | 64 |
| Total | 197 |
Baseline characteristics
| Characteristic | Standard Cap | 0.3mm XPF Cap | 0.5mm XPF Cap | Total |
|---|---|---|---|---|
| Age, Continuous | 53 years | 53 years | 53 years | 53 years |
| Region of Enrollment United States | 59 participants | 74 participants | 64 participants | 197 participants |
| Sex: Female, Male Female | 29 Participants | 36 Participants | 30 Participants | 95 Participants |
| Sex: Female, Male Male | 30 Participants | 38 Participants | 34 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 74 | 0 / 64 |
| other Total, other adverse events | 0 / 59 | 0 / 74 | 0 / 64 |
| serious Total, serious adverse events | 0 / 59 | 0 / 74 | 0 / 64 |
Outcome results
Primary
Absolute Radiation Exposure Outside of Cap
The cumulative radiation doses were defined as the summation of all correspondent equivalent doses measured.
Time frame: 1 day
Population: The primary objective of the trial is to show how much radiation attenuation is provided by XPF in absolute and relative terms.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Cap | Absolute Radiation Exposure Outside of Cap | 132 uSv |
| 0.3mm XPF Cap | Absolute Radiation Exposure Outside of Cap | 118 uSv |
| 0.5mm XPF Cap | Absolute Radiation Exposure Outside of Cap | 59 uSv |
Primary
Radiation Attenuation in Percentage (%)
The null hypothesis is that the XPF 0.5mm lead-equivalent caps attenuation is equal to the XPF 0.3mm lead-equivalent and standard cap attenuations. The alternative hypothesis is that the XPF 0.5mm lead-equivalent cap attenuation is superior or inferior to the XPF 0.3mm lead-equivalent and standard cap attenuations. The groups will be compared separately and a pooled analysis, comparing XPF 0.5mm and 0.3mm combined vs. standard is also planned.The radiation protection (radiation dose reduction) expressed as a percentage was calculated by subtracting radiation measured underneath the cap from radiation measured outside the cap and then dividing this difference by the product of radiation measured outside the cap multiplied by 100.
Time frame: 1 day
Population: Mean Radiation Protection is described under Outcome Measure Data below.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Cap | Radiation Attenuation in Percentage (%) | 12 Percentage |
| 0.3mm XPF Cap | Radiation Attenuation in Percentage (%) | 91.5 Percentage |
| 0.5mm XPF Cap | Radiation Attenuation in Percentage (%) | 97.1 Percentage |
Secondary
Operator Comfort Assessment
After completion of the last procedure on each day, the operators were asked to rate the comfort of wearing the cap on a scale from 0 (unbearably heavy, badly fitting) to 100 (very light, well fitting).
Time frame: 1 day per participant, a total of 197 operator days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Cap | Operator Comfort Assessment | 90 score on a scale |
| 0.3mm XPF Cap | Operator Comfort Assessment | 90 score on a scale |
| 0.5mm XPF Cap | Operator Comfort Assessment | 90 score on a scale |
Secondary
Operator Comfort Assessment Based on Weight
After completion of the last procedure on each day, the caps worn by the operators were weighed to assess comfort of wearing the standard cap, XPF 0.3mm and XPF 0.5mm caps. The operators were asked to rate the comfort of wearing the cap on a scale from 0 (unbearably heavy, badly fitting) to 100 (very light, well fitting).
Time frame: 1 day per participant, a total of 197 operator days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Cap | Operator Comfort Assessment Based on Weight | 12.5 grams |
| 0.3mm XPF Cap | Operator Comfort Assessment Based on Weight | 123.7 grams |
| 0.5mm XPF Cap | Operator Comfort Assessment Based on Weight | 118.4 grams |