Cardiac Catheterization, Radiation Exposure
Conditions
Keywords
ControlRad System, Cardiac Catheterization, Radiation Exposure, Fluoroscopic x-ray
Brief summary
The purpose of this study is to determine whether the ControlRad system device when installed in Fluoroscopic (x-ray) machine reduces radiation dose to operators (Doctors and nurses) and to the patient who is undergoing cardiac Catheterization and electrophysiology (EP) implant procedures.
Detailed description
This is a Prospective, randomized (like a flip of a coin) single center study evaluating the ControlRad system device when installed - retrofitted on existing C-arms for fluoroscopy (x-ray) will reduce radiation exposure without compromising image quality in the region of interest and overall workflow during cardiac catheterization and electrophysiology (EP) implant procedures. Enrollment will be limited to 40 cardiac catheterization, and 30 pacemaker and/or ICD procedures. All patients presenting to Beaumont Hospital Royal Oak who are scheduled for cardiac catheterization with coronary angiography and electrophysiology implant in Cath Lab 5 where device is installed will be considered for inclusion in the study. Physicians and staff (20 fellows; 35 attending physicians; and 56 Cath-lab staff,including Nurse/Anesthesia team) will be invited to participate in the study. For each procedure, 3 staff members will be study subjects: a) the primary operator, b) the secondary operator, c) the nurse/tech and or Anesthetist who circulates in the room. Different operators and staff may participate in each case depending on cath-lab scheduling. The Primary operator is the physician who usually stands nearest to the C-arm. In most cases in Beaumont this is a Cardiology Fellow in cardiac catheterization cases and Attending Physician for the EP cases. The Secondary operator is the physician who typically stands to the right of the primary operator and in most cases is the attending cardiologist or scrub assistant (nurse/technician). The Nurse or Anesthesia team typically circulates in the room and is responsible for monitoring the patient, administering medications and obtaining equipment for the procedure. Two methods will be used to measure radiation dose during the catheterization procedure. The Real-time Dosimeter Badge (RaySafe) and the Landauer Luxel Aluminium Oxide Dosimeter Badges. Cardiac Catheterization and electrophysiology implant procedures will be performed according to standard guidelines. Participants will be randomized 1:1 to either cardiac catheterization without ControlRad or cardiac catheterization with the ControlRad system. The same 1:1 randomization process will be applied to the EP patient population. Participants will be blinded to the randomization. Once procedure is done,participation also ended and the badges will be removed by the Radiation Safety Officer or research coordinator.
Interventions
RADIATIONControlRad System
Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.
RADIATIONWithout ControlRad System
Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.
Sponsors
Corewell Health East
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participant will be blinded to the arm assigned to; but the investigators, cath lab operators and staff will be informed of the randomized assignment.
Intervention model description
Randomized 1:1 like a flip of a coin, to receive either cardiac catheterization and or electrophysiology implant procedures without ControlRad system or cardiac catheterization and or electrophysiology (EP) implant procedures with the ControlRad system.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \- Patient * Scheduled to undergo left heart catheterization with angiography, and/or percutaneous coronary intervention * Scheduled to undergo pacemaker or ICD implant * EP device upgrade * Able to provide written informed consent prior to the procedure * Age ≥18 years * Physicians and Staff o Able to provide consent for the study
Exclusion criteria
* \- Patient * Cardiogenic shock * Reason for cath procedure is pericardiocentesis * Subcutaneous ICDs * Lead revisions * Inability to provide informed consent * Pregnant * Physicians and Staff * Those who are not willing to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiation Dose to Primary Operator (RaySafe), Cardiac Catheterization | During each cardiac catheterization, an average of 90 minutes | Median effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case. |
| Radiation Dose to Primary Operator (Luxel Dosimeter), Cardiac Catheterization | During each cardiac catheterization, an average of 90 minutes | Mean effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm. |
| Radiation Dose to Primary Operator, EP Procedure (Luxel) | During each EP implant procedure, an average of 90 minutes | Mean effective radiation dose in microsievert (μSv) to the primary operator at the end of each EP implant procedure. A single Luxel dosimeter was and a cumulative dose was recorded. |
| Radiation Dose to Primary Operator, EP Procedure (RaySafe) | During each EP implant procedure, an average of 90 minutes duration | Median effective radiation dose in microsievert (μSv) to the primary operator at the end of each EP implant procedure using a RaySafe dosimeter. This is measured after each case. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiation Dose to Patient, Cardiac Catheterization | During each cardiac catheterization, an average of 90 minutes | Median radiation dose-area product (DAP) to the patient at the end of each cardiac catheterization case using data from a fluoroscopy machine. DAP is defined as the absorbed dose multiplied by the area irradiated micro-gray μGy\*m\^2. |
| Radiation Dose in Cath Lab Room #5, Cardiac Catheterization | During each cardiac catheterization, an average of 90 minutes | Mean radiation dose microsieverts (μSv) at the end of each cardiac catheterization case at a standard location on the wall of the catheterization laboratory. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm. |
| Radiation Dose to Secondary Operator, EP Procedure (RaySafe) | During each EP implant procedure, an average of 90 minutes | Mean effective radiation dose (μSv) to the secondary operator at the at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case. |
| Radiation Dose to Secondary Operator, EP Procedure (Luxel) | During each EP implant procedure, an average of 90 minutes | Mean effective radiation dose (μSv) to the secondary operator at the at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm. |
| Radiation Dose to Secondary Operator, Cardiac Catheterization (RaySafe) | During each cardiac catheterization, an average of 90 minutes | Median effective radiation dose (μSv) to the secondary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case. |
| Radiation Dose to Nurse or Anesthetist, EP Procedure (Luxel) | During each EP implant procedure, an average of 90 minutes | Mean effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm. |
| Radiation Dose to Patient, EP Procedure | During each EP implant procedure, an average of 30-45 minutes of active radiation | Mean radiation dose-area product (DAP) to the patient at the end of each EP implant procedure using data from a fluoroscopy machine. DAP is defined as the absorbed dose multiplied by the area irradiated (μGy\*m\^2) |
| Radiation Dose in Cath Lab Room #5, EP Procedure | During each EP implant procedure, an average of 90 minutes | Mean radiation dose (μSv) at the end of each EP implant procedure at a standard location on the wall of the catheterization laboratory. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm. |
| Radiation Dose to Nurse or Anesthetist, EP Procedure (RaySafe) | During each EP implant procedure, an average of 90 minutes | Median effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case. |
| Radiation Dose to Secondary Operator (Luxel Dosimeter), Cardiac Catheterization | During each cardiac catheterization, an average of 90 minutes | Mean effective radiation dose in microsievert (μSv) to the secondary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm. |
| Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (RaySafe) | During each cardiac catheterization, an average of 90 minutes | Median effective radiation dose in microsievert (μSv) to the Nurse 0r Anesthetist at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case. |
| Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (Luxel) | During each cardiac catheterization, an average of 90 minutes | Mean effective radiation dose in microsievert (μSv) to the Nurse or Anesthetist at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ControlRad System Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5
ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5. | 85 |
| Without ControlRad System Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5.
Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device. | 85 |
| Total | 170 |
Baseline characteristics
| Characteristic | Without ControlRad System | Total | ControlRad System |
|---|---|---|---|
| Age, Continuous | 57.1 years STANDARD_DEVIATION 9.9 | 63.7 years STANDARD_DEVIATION 1.2 | 70.3 years STANDARD_DEVIATION 4.6 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 85 participants | 170 participants | 85 participants |
| Sex: Female, Male Female | 36 Participants | 71 Participants | 35 Participants |
| Sex: Female, Male Male | 49 Participants | 99 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 85 | 0 / 85 |
| other Total, other adverse events | 0 / 85 | 0 / 85 |
| serious Total, serious adverse events | 0 / 85 | 1 / 85 |
Outcome results
Primary
Radiation Dose to Primary Operator, EP Procedure (Luxel)
Mean effective radiation dose in microsievert (μSv) to the primary operator at the end of each EP implant procedure. A single Luxel dosimeter was and a cumulative dose was recorded.
Time frame: During each EP implant procedure, an average of 90 minutes
Population: This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ControlRad System | Radiation Dose to Primary Operator, EP Procedure (Luxel) | 21.7 microsieverts |
| Without ControlRad System | Radiation Dose to Primary Operator, EP Procedure (Luxel) | 58.1 microsieverts |
Primary
Radiation Dose to Primary Operator, EP Procedure (RaySafe)
Median effective radiation dose in microsievert (μSv) to the primary operator at the end of each EP implant procedure using a RaySafe dosimeter. This is measured after each case.
Time frame: During each EP implant procedure, an average of 90 minutes duration
Population: This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ControlRad System | Radiation Dose to Primary Operator, EP Procedure (RaySafe) | 25 microsieverts |
| Without ControlRad System | Radiation Dose to Primary Operator, EP Procedure (RaySafe) | 61 microsieverts |
Primary
Radiation Dose to Primary Operator (Luxel Dosimeter), Cardiac Catheterization
Mean effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.
Time frame: During each cardiac catheterization, an average of 90 minutes
Population: This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ControlRad System | Radiation Dose to Primary Operator (Luxel Dosimeter), Cardiac Catheterization | 18 microsievert |
| Without ControlRad System | Radiation Dose to Primary Operator (Luxel Dosimeter), Cardiac Catheterization | 41 microsievert |
Primary
Radiation Dose to Primary Operator (RaySafe), Cardiac Catheterization
Median effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.
Time frame: During each cardiac catheterization, an average of 90 minutes
Population: This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ControlRad System | Radiation Dose to Primary Operator (RaySafe), Cardiac Catheterization | 18 microsievert |
| Without ControlRad System | Radiation Dose to Primary Operator (RaySafe), Cardiac Catheterization | 39 microsievert |
Secondary
Radiation Dose in Cath Lab Room #5, Cardiac Catheterization
Mean radiation dose microsieverts (μSv) at the end of each cardiac catheterization case at a standard location on the wall of the catheterization laboratory. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.
Time frame: During each cardiac catheterization, an average of 90 minutes
Population: This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ControlRad System | Radiation Dose in Cath Lab Room #5, Cardiac Catheterization | 15 microsieverts |
| Without ControlRad System | Radiation Dose in Cath Lab Room #5, Cardiac Catheterization | 25 microsieverts |
Secondary
Radiation Dose in Cath Lab Room #5, EP Procedure
Mean radiation dose (μSv) at the end of each EP implant procedure at a standard location on the wall of the catheterization laboratory. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.
Time frame: During each EP implant procedure, an average of 90 minutes
Population: This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ControlRad System | Radiation Dose in Cath Lab Room #5, EP Procedure | 0 microsieverts |
| Without ControlRad System | Radiation Dose in Cath Lab Room #5, EP Procedure | 0 microsieverts |
Secondary
Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (Luxel)
Mean effective radiation dose in microsievert (μSv) to the Nurse or Anesthetist at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.
Time frame: During each cardiac catheterization, an average of 90 minutes
Population: This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ControlRad System | Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (Luxel) | NA microsievert |
| Without ControlRad System | Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (Luxel) | NA microsievert |
Secondary
Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (RaySafe)
Median effective radiation dose in microsievert (μSv) to the Nurse 0r Anesthetist at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.
Time frame: During each cardiac catheterization, an average of 90 minutes
Population: This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ControlRad System | Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (RaySafe) | NA microsievert |
| Without ControlRad System | Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (RaySafe) | NA microsievert |
Secondary
Radiation Dose to Nurse or Anesthetist, EP Procedure (Luxel)
Mean effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.
Time frame: During each EP implant procedure, an average of 90 minutes
Population: This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ControlRad System | Radiation Dose to Nurse or Anesthetist, EP Procedure (Luxel) | 0 microsieverts |
| Without ControlRad System | Radiation Dose to Nurse or Anesthetist, EP Procedure (Luxel) | 3.8 microsieverts |
Secondary
Radiation Dose to Nurse or Anesthetist, EP Procedure (RaySafe)
Median effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.
Time frame: During each EP implant procedure, an average of 90 minutes
Population: This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ControlRad System | Radiation Dose to Nurse or Anesthetist, EP Procedure (RaySafe) | 0 microsieverts |
| Without ControlRad System | Radiation Dose to Nurse or Anesthetist, EP Procedure (RaySafe) | 2 microsieverts |
Secondary
Radiation Dose to Patient, Cardiac Catheterization
Median radiation dose-area product (DAP) to the patient at the end of each cardiac catheterization case using data from a fluoroscopy machine. DAP is defined as the absorbed dose multiplied by the area irradiated micro-gray μGy\*m\^2.
Time frame: During each cardiac catheterization, an average of 90 minutes
Population: This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ControlRad System | Radiation Dose to Patient, Cardiac Catheterization | 2276 μGy*m^2 |
| Without ControlRad System | Radiation Dose to Patient, Cardiac Catheterization | 3487 μGy*m^2 |
Secondary
Radiation Dose to Patient, EP Procedure
Mean radiation dose-area product (DAP) to the patient at the end of each EP implant procedure using data from a fluoroscopy machine. DAP is defined as the absorbed dose multiplied by the area irradiated (μGy\*m\^2)
Time frame: During each EP implant procedure, an average of 30-45 minutes of active radiation
Population: This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ControlRad System | Radiation Dose to Patient, EP Procedure | 43.7 μGy*m^2 |
| Without ControlRad System | Radiation Dose to Patient, EP Procedure | 72.5 μGy*m^2 |
Secondary
Radiation Dose to Secondary Operator, Cardiac Catheterization (RaySafe)
Median effective radiation dose (μSv) to the secondary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.
Time frame: During each cardiac catheterization, an average of 90 minutes
Population: This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ControlRad System | Radiation Dose to Secondary Operator, Cardiac Catheterization (RaySafe) | 12 microsievert |
| Without ControlRad System | Radiation Dose to Secondary Operator, Cardiac Catheterization (RaySafe) | 21 microsievert |
Secondary
Radiation Dose to Secondary Operator, EP Procedure (Luxel)
Mean effective radiation dose (μSv) to the secondary operator at the at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.
Time frame: During each EP implant procedure, an average of 90 minutes
Population: This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ControlRad System | Radiation Dose to Secondary Operator, EP Procedure (Luxel) | 1.6 microsieverts |
| Without ControlRad System | Radiation Dose to Secondary Operator, EP Procedure (Luxel) | 9 microsieverts |
Secondary
Radiation Dose to Secondary Operator, EP Procedure (RaySafe)
Mean effective radiation dose (μSv) to the secondary operator at the at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.
Time frame: During each EP implant procedure, an average of 90 minutes
Population: This outcome measured only the EP procedures, 43 in the ControlRad group and 47 in the Without ControlRad group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ControlRad System | Radiation Dose to Secondary Operator, EP Procedure (RaySafe) | 3 microsieverts |
| Without ControlRad System | Radiation Dose to Secondary Operator, EP Procedure (RaySafe) | 5 microsieverts |
Secondary
Radiation Dose to Secondary Operator (Luxel Dosimeter), Cardiac Catheterization
Mean effective radiation dose in microsievert (μSv) to the secondary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.
Time frame: During each cardiac catheterization, an average of 90 minutes
Population: This outcome measured only the cardiac catheterization procedures, 42 participants in the ControlRad group and 38 in the group without ControlRad. A single badge was used for all cases, the result is provided as a number per arm. The number is cumulative of the arm with no measure of dispersion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ControlRad System | Radiation Dose to Secondary Operator (Luxel Dosimeter), Cardiac Catheterization | 13 microsievert |
| Without ControlRad System | Radiation Dose to Secondary Operator (Luxel Dosimeter), Cardiac Catheterization | 26 microsievert |