PROTECT: Radioprotective Light-weight Caps in the Interventional Cardiology Setting

• Sponsor: Baptist Health South Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT01620658
• Collaborator: (none)
• Enrollment: 197
• Location: 1
• Arms: 3
• Actual Duration (Months): 20
• Patients Per Site Per Month: 9.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Occupational Exposure to Radiation	Device: 0.5mm XPF cap; Device: 0.3mm XPF cap; Device: Standard cap	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 197 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Radioprotective Light-weight Caps in the Interventional Cardiology Setting: a Randomized Controlled Trial
• Actual Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: standard cap Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.	Device: Standard cap; Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
Experimental: 0.3mm XPF cap Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.	Device: 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.
Experimental: 0.5mm XPF cap Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.	Device: 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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. Absolute Radiation Exposure Outside of Cap [1 day]

   The cumulative radiation doses were defined as the summation of all correspondent equivalent doses measured.

Secondary Outcome Measures

1. 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).

2. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baptist Hospital of Miami, Miami Cardiac and Vascular Institute	Miami	Florida	United States	33176

Sponsors and Collaborators

• Baptist Health South Florida

Investigators

• Principal Investigator: Raul Herrera, MD, Baptist Hospital of Miami, Miami Cardiac and Vascular Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Raul Herrera, MD, Director, Division of Clinical Research & Outcomes, Baptist Health South Florida
• ClinicalTrials.gov Identifier: NCT01620658
• Other Study ID Numbers: PROTECT
• First Posted: Jun 15, 2012
• Last Update Posted: Mar 7, 2022
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Raul Herrera, MD, Director, Division of Clinical Research & Outcomes, Baptist Health South Florida: Occupational Exposure to Radiation

Study Results

Participant Flow

Recruitment Details	Patients presenting to the Miami Cardiac and Vascular Institute for Imaging Study/Procedure.
Pre-assignment Detail	Voluntary patient participation. PI responsible for patient selection.

Arm/Group Title	Standard Cap	0.3mm XPF Cap	0.5mm XPF Cap
Arm/Group Description	Interventionalist wear a standard fabric cap during fluoroscopy guided interventions. Standard cap: Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.	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.	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.
Period Title: Overall Study
STARTED	59	74	64
COMPLETED	35	45	44
NOT COMPLETED	24	29	20

Baseline Characteristics

Arm/Group Title	Standard Cap	0.3mm XPF Cap	0.5mm XPF Cap	Total
Arm/Group Description	Interventionalist wear a standard fabric cap during fluoroscopy guided interventions. Standard cap: Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.	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.	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.	Total of all reporting groups
Overall Participants	59	74	64	197
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	53	53	53	53
Sex: Female, Male (Count of Participants)
Female	29 49.2%	36 48.6%	30 46.9%	95 48.2%
Male	30 50.8%	38 51.4%	34 53.1%	102 51.8%
Region of Enrollment (participants) [Number]
United States	59 100%	74 100%	64 100%	197 100%

Outcome Measures

1. Primary Outcome

Title	Radiation Attenuation in Percentage (%)
Description	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

Outcome Measure Data

Analysis Population Description

Mean Radiation Protection is described under Outcome Measure Data below.

Arm/Group Title	Standard Cap	0.3mm XPF Cap	0.5mm XPF Cap
Arm/Group Description	Interventionalist wear a standard fabric cap during fluoroscopy guided interventions. Standard cap: Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.	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.	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.
Measure Participants	35	45	44
Mean (95% Confidence Interval) [Percentage]	12	91.5	97.1

2. Primary Outcome

Title	Absolute Radiation Exposure Outside of Cap
Description	The cumulative radiation doses were defined as the summation of all correspondent equivalent doses measured.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

The primary objective of the trial is to show how much radiation attenuation is provided by XPF in absolute and relative terms.

Arm/Group Title	Radiation Exposure Monitored With Standard Caps.	Radiation Exposure Monitored With XPF 0.3 mm Caps	Radiation Exposure Monitored With XPF 0.5mm Caps
Arm/Group Description	Operators were randomly assigned to wear standard fabric Caps. Radiation doses were measured by using dosimeters placed outside and underneath the caps.	Operators were randomly assigned to wear the 0.3 mm Caps. Radiation doses were measured by using dosimeters placed outside and underneath the caps.	Operators were randomly assigned to wear lead-equivalent XPF caps. Radiation doses were measured by using dosimeters placed outside and underneath the caps.
Measure Participants	35	45	44
Mean (95% Confidence Interval) [uSv]	132	118	59

3. Secondary Outcome

Title	Operator Comfort Assessment
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Caps	XPF 0.3 mm	XPF 0.5 mm
Arm/Group Description	Operators were randomly assigned to wear standard fabric Caps. The operator comfort rating on the VAS (score range, 0-100), with higher numbers indicating better comfort, was obtained in all cases and for all operators.	Operators were randomly assigned to wear XPF 0.3mm Caps. The operator comfort rating on the VAS (score range, 0-100), with higher numbers indicating better comfort, was obtained in all cases and for all operators.	Operators were randomly assigned to wear XPF 0.5mm Caps. The operator comfort rating on the VAS (score range, 0-100), with higher numbers indicating better comfort, was obtained in all cases and for all operators.
Measure Participants	59	74	64
Mean (Full Range) [score on a scale]	90	90	90

4. Secondary Outcome

Title	Operator Comfort Assessment Based on Weight
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Caps	XPF 0.5 mm	XPF 0.3 mm
Arm/Group Description	Operators were randomly assigned to wear standard fabric Caps. The operator comfort rating on the VAS (score range, 0-100), with higher numbers indicating better comfort, was obtained in all cases and for all operators.	Operators were randomly assigned to wear XPF 0.5mm Caps. The operator comfort rating on the VAS (score range, 0-100), with higher numbers indicating better comfort, was obtained in all cases and for all operators.	Operators were randomly assigned to wear XPF 0.3mm Caps. The operator comfort rating on the VAS (score range, 0-100), with higher numbers indicating better comfort, was obtained in all cases and for all operators.
Measure Participants	59	64	74
Mean (Full Range) [grams]	12.5	123.7	118.4

Adverse Events

Arm/Group Title	Standard Cap		0.3mm XPF Cap		0.5mm XPF Cap
Arm/Group Description	Interventionalist wear a standard fabric cap during fluoroscopy guided interventions. Standard cap: Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.		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.		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.
All Cause Mortality
	Standard Cap		0.3mm XPF Cap		0.5mm XPF Cap
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/74 (0%)		0/64 (0%)
Serious Adverse Events
	Standard Cap		0.3mm XPF Cap		0.5mm XPF Cap
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/74 (0%)		0/64 (0%)
Other (Not Including Serious) Adverse Events
	Standard Cap		0.3mm XPF Cap		0.5mm XPF Cap
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/74 (0%)		0/64 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.