Reduce Radiation Exposure in Fluoroscopic Interventions Evaluation (REDEFINE): A Prospective, Randomized Evaluation of the ControlRad System to Reduce Radiation Exposure During Cardiac Catheterization and Electrophysiology (EP) Procedures.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Radiation Dose to Primary Operator (RaySafe), Cardiac Catheterization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participant will be blinded to the arm assigned to; but the investigators, cath lab operators and staff will be informed of the randomized assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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
排除标准
- •- Patient
- •Cardiogenic shock
- •Reason for cath procedure is pericardiocentesis
- •Subcutaneous ICDs
- •Lead revisions
- •Inability to provide informed consent
- •Physicians and Staff
- •Those who are not willing to participate in the study
结局指标
主要结局
Radiation Dose to Primary Operator (RaySafe), Cardiac Catheterization
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Radiation Dose to Nurse or Anesthetist, EP Procedure (Luxel)(During each EP implant procedure, an average of 90 minutes)
- Radiation Dose to Patient, EP Procedure(During each EP implant procedure, an average of 30-45 minutes of active radiation)
- Radiation Dose in Cath Lab Room #5, EP Procedure(During each EP implant procedure, an average of 90 minutes)
- Radiation Dose to Secondary Operator (Luxel Dosimeter), Cardiac Catheterization(During each cardiac catheterization, an average of 90 minutes)
- Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (Luxel)(During each cardiac catheterization, an average of 90 minutes)
- Radiation Dose to Secondary Operator, EP Procedure (RaySafe)(During each EP implant procedure, an average of 90 minutes)
- Radiation Dose to Secondary Operator, EP Procedure (Luxel)(During each EP implant procedure, an average of 90 minutes)
- Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (RaySafe)(During each cardiac catheterization, an average of 90 minutes)
- Radiation Dose to Secondary Operator, Cardiac Catheterization (RaySafe)(During each cardiac catheterization, an average of 90 minutes)
- Radiation Dose to Patient, Cardiac Catheterization(During each cardiac catheterization, an average of 90 minutes)
- Radiation Dose in Cath Lab Room #5, Cardiac Catheterization(During each cardiac catheterization, an average of 90 minutes)
- Radiation Dose to Nurse or Anesthetist, EP Procedure (RaySafe)(During each EP implant procedure, an average of 90 minutes)
研究者
Simon Dixon, MD
Principal Investigator
William Beaumont Hospitals