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Brain Radiation Exposure and Attenuation During Invasive Cardiology Procedures (BRAIN)

2013년 7월 26일 업데이트: Ryan Reeves, University of California, San Diego

Brain Radiation Exposure and Attenuation During Invasive Cardiology Procedures.

Invasive cardiac procedures involve procedural guidance with x-rays in the form of fluoroscopy. X-ray exposure poses a potential risk of acute and long-term complications to staff involved in these procedures. Lead shields are placed between the operators (on their left side) and the x-ray source to limit exposure. However as the operator requires direct access to the patient and x-ray scatter occurs, full protection is not possible. Lead gowns, thyroid collars, and leaded glasses are typically worn to protect the body, thyroid, and eyes respectively, but their thickness is limited by their relatively heavy weight. Nevertheless this leaves the brain exposed. Further, interest in the risk of brain cancer in invasive cardiologists has re-emerged after a recent report of left-sided brain cancer in primary operators of interventional cardiology procedures. Lead caps have been tested in the past but the relatively heavyweight of lead has limited wide-spread implementation. The cap typically worn during invasive procedures is lightweight, has no significant x-ray absorption properties, and is worn to help maintain a sterile environment. A novel, lead-free cap, composed mainly of barium sulfate and bismuth oxide, has been developed that has been shown to absorb x-rays while being significantly lighter than lead. The investigators propose using multiple x-ray detectors to test exposure differences between the primary and secondary operators, the left side and right side of the head, and absorption via a lead-free cap.

연구 개요

상세 설명

This is a prospective study evaluating radiation exposure to operators of invasive cardiovascular procedures at the UCSD Medical Center in La Jolla. Primary and secondary operators of cardiac catheterization procedures using fluoroscopy guidance, including cardiac catheterization, coronary angiography, and interventional procedures will wear multiple dosimeters to evaluate levels of radiation exposure. The primary and secondary operators will wear six dosimeters on their heads; three outside the non-lead attenuating cap and three underneath the cap. Above and beneath the cap, the dosimeters will be on the left side, in the center, and on the right side of the head. The dosimeters will be worn for a target of at least 50 procedures for each operator. The primary operators will be closest to the procedural site and the fluoroscopy unit for the majority of the procedure, while the secondary operators will be to the right side of the primary operators during the procedures. The operators will maintain this designation while participating in the study. All operators will continue to wear the dosimeters issued by the catheterization laboratory as part of standard radiation monitoring.

Each operator will be assigned six dosimeters, which will be secured within the cap at the time of assignment. The use of each cap and respective set of dosimeters will be recorded in a log book in the secure cardiac catheterization laboratory and associated with specific cardiac case numbers. Specific factors related to operator radiation exposure for each procedure will be recorded including: operator height, patient weight and BMI, dose area product (DAP), fluoroscopy time, length of procedure, type of procedure, access site, and complexity of procedure as determined by the attending physician. The operators will comment on the comfort of the cap using a semi-quantitative scale and the levels of exposure will be measured from the dosimeters. The operators will also be asked to compare and contrast the study cap with any other attenuating or non-attenuating cap that has been previously worn. At the conclusion of the study, statistical analysis will be performed to determine the differential levels of exposure between the primary and secondary operators, between different sides of the head, and the attenuation ability of the XPF cap. The dosimeters on the outside of the cap will serve as the control in evaluating the attenuating ability of the cap compared to the corresponding dosimeters on the inside. Each dosimeter location on the outside of the cap will be compared to the other locations for both the outside and the inside sets. And finally, the exposure measurements will be compared between the primary and secondary operators for each dosimeter location. The specific factors listed above that affect operator exposure will be taken into account as well.

연구 유형

관찰

등록 (실제)

11

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • California
      • La Jolla, California, 미국, 92093
        • University of California, San Diego, Sulpizio Cardiovascular Center

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

We plan to enroll up to 12 invasive cardiologists routinely performing cardiac catheterization procedures at the UCSD Medical Center, La Jolla campus. We plan to monitor radiation exposure in at least 50 cases for each operator.

설명

Inclusion Criteria:

  • 18 years or older
  • Routinely performing cardiac catheterization procedures as the primary or secondary operators

Exclusion Criteria:

  • Cases with emergent indications including STEMI will be excluded
  • Cases consisting of solely right heart catheterization will be excluded

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Differential radiation exposure from corresponding locations on the outside and inside of the non-lead attenuating cap.
기간: Radiation exposure has been ongoing and will be assessed upon dosimeter measurement in within 1 month by an independent radiation monitoring service.
Radiation exposure has been ongoing and will be assessed upon dosimeter measurement in within 1 month by an independent radiation monitoring service.

2차 결과 측정

결과 측정
기간
Differential radiation exposure between the left and right sides of the heads of invasive cardiology operators.
기간: Dosimeters measurement to be read/reported within one month.
Dosimeters measurement to be read/reported within one month.

기타 결과 측정

결과 측정
기간
Differential radiation exposure between primary and secondary operators of invasive cardiology procedures.
기간: Dosimeters measurement to be read/reported within one month.
Dosimeters measurement to be read/reported within one month.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2013년 1월 1일

기본 완료 (실제)

2013년 7월 1일

연구 등록 날짜

최초 제출

2013년 7월 19일

QC 기준을 충족하는 최초 제출

2013년 7월 26일

처음 게시됨 (추정)

2013년 7월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 7월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2013년 7월 26일

마지막으로 확인됨

2013년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • UCSD #120980

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