Ultrasound-guided Femoral Vein Accessibility, Safety and Time for Atrial Fibrillation Treatment (ULTRA-FAST)
Ultrasound-guided or Anatomical Femoral Venipuncture for Pulmonary Vein Isolation for Atrial Fibrillation Treatment
연구 개요
상태
상세 설명
The number of pulmonary vein isolation (PVI) therapy for atrial fibrillation (AF) is increasing. Multiple femoral vein cannulation is mandatory for this procedure. There are mainly two methods to cannulate the femoral vein; by anatomical landmark or by under real-time ultrasound-guided. As high anticoagulant level is required for the procedure, there are 0-13% of vascular access complication.
Real-time ultrasound assistance for central venous catheter cannulation has been proven to reduce complications. In the field of AF treatment, multiple femoral vein cannulation is required as many catheter is required for the procedure and larger sheaths are inserted with a high anticoagulant level during the procedure. In this setting, the use of ultrasound use is not well studied.
The current study is to confirm whether real time ultrasound-guided femoral vein cannulation for PVI can prevent complications, reduce puncture time, puncture attempts and accidental artery puncture compared to conventional anatomical approach. Two seethes for each femoral vein is going to be cannulated.
The study design is a multicenter prospective randomized trial to compare the above safety and efficacy by using the ultrasound-guided and anatomical landmark approach. Also time for cannulation, number of puncture attempts, need of X-ray for cannulation will be analyzed in the setting of patient factors including age, body mass index and sex.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients undergoing pulmonary vein isolation with radiofrequency catheter ablation for atrial fibrillation treatment.
Exclusion Criteria:
- Patients with prior known vascular access problems or priory included to the current study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Real-time ultrasound-guided puncture
Cannulate each femoral veins with two wires with real-time ultrasound-guided method.
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A 7 megahertz ultrasound linear probe will be used.
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다른: Anatomical landmark guided puncture
Cannulate each femoral veins with two wires with the anatomical landmark guided method.
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Anatomical landmark puncture
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Major complications
기간: After the puncture up to 12 weeks
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Total patient number of vascular complications requiring surgical treatment, retroperitoneal hematoma requiring blood transfusion or hemoglobin drop of 3 >g/dl, strong pain at the groin, prolonging hospital stay and requiring hospital admission after discharge.
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After the puncture up to 12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Unsuccessful femoral vein cannulation
기간: Immediately after the puncture
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Number of patients with unsuccessful femoral vein cannulation defined as crossing over to the other randomized method or change of operator to cannulate all wires.
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Immediately after the puncture
|
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Number of puncture attempts
기간: Immediately after the puncture
|
Number of puncture attempts to cannulate all wires.
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Immediately after the puncture
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Total puncture time
기간: Immediately after the puncture
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Time from giving anesthesia to the groin till confirming all wires in the infra vena cava with the X-ray.
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Immediately after the puncture
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Number of artery mis-punctures
기간: Immediately after the puncture
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Number of artery mis-punctures attempts to cannulate all wires.
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Immediately after the puncture
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Use of X-ray for successful wire cannulation
기간: Immediately after the puncture
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If there is a need of X-ray to cannulate the wire into the infra vena cava.
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Immediately after the puncture
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공동 작업자 및 조사자
수사관
- 연구 책임자: Joseph Kautzner, MD, PhD, Institute for Clinical and Experimental Medicine
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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