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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
他の：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Major complications
時間枠：After the puncture up to 12 weeks
|
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.
|
After the puncture up to 12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Unsuccessful femoral vein cannulation
時間枠：Immediately after the puncture
|
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.
|
Immediately after the puncture
|
|
Number of puncture attempts
時間枠：Immediately after the puncture
|
Number of puncture attempts to cannulate all wires.
|
Immediately after the puncture
|
|
Total puncture time
時間枠：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
時間枠：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
|
|
Use of X-ray for successful wire cannulation
時間枠：Immediately after the puncture
|
If there is a need of X-ray to cannulate the wire into the infra vena cava.
|
Immediately after the puncture
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Joseph Kautzner, MD, PhD、Institute for Clinical and Experimental Medicine
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
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最終確認日
詳しくは
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