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临床试验/NCT04382430
NCT04382430已完成不适用

Ultrasound Axillary Vein Access: Evaluation of Learning Curve for an Alternative Approach to Cardiac Device Implantation

University of Kansas Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年5月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Venous access time between US guided and conventional technique

研究概览

简要总结

The purpose of this study is to determine the learning curve associated with Ultrasound (US) guided axillary vein access for cardiac device implantation based on length of procedure among operators of various levels of experience and to assess the 30-day complication rate for patients undergoing US guided device placement versus traditional implant methods.

详细描述

Ultrasound (US) guided axillary vein access for device implantation is an uncommon approach to gain venous access for cardiac device implantation - an extremely common procedure. However, there has been a growing trend of utilizing this approach to obtain venous access for device implantation among operators. Axillary vein access was described back as far as 1997, when it was utilized for contrast guided venipuncture to access the axillary vein for device implantation. Literature has suggested that an axillary venous approach, with either a superficial landmark or radiographic contrast, has better long-term efficacy and lower lead complications than a conventional subclavian approach for patients that had permanent pacemaker implantation. There are a variety of ways to access the axillary vein including contrast venography to help localization, "blind puncture" (utilizing fluoroscopy to identify anatomical landmarks), and US. More recently, operators have begun to utilize US guidance for axillary vein access. Esmaiel has described that US guidance for axillary vein access could potentially improve the success rate of venous access and limit complications. Others, albeit few, have reported US guided access for cardiac device implantation has the ability to reduce complications, is faster to complete, and easier to learn. According to the Agency for Healthcare Research and Quality in the United States, US guided central venous catheter placement is one of the 11 patient safety practices that have the strongest evidence supporting its use in improving patient outcomes. Evidence supports US guidance being standard of care in central venous catheter placement and using US for axillary access as helpful in cardiac device implantation, but providers still utilize predominantly alternative approaches to obtain venous access via the subclavian vein, cephalic cutdown, extrathoracic axillary using fluoroscopy and thoracic axillary using fluoroscopy.

Currently, there is limited data describing outcomes, the efficiency of US guided axillary access for cardiac device implantation, and the learning curve associated with this technique. Data suggests that utilizing the US approach can improve outcomes, be more efficient, and be easier to learn. Investigators recently reported a high success (95%) and low complication rate with US guided axillary access in 187 patients. Despite this limited data, operators still largely use alternative approaches for venous access. In part, this may be due to the learning curve associated with US axillary venous access.

While there is data demonstrating the utility of US guided axillary access, there is little evidence showing the learning curve for operators associated with this technique. The aim of this project is to assess the learning curve of this technique among operators of various levels of experience.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Sign written Informed Consent Form.
  • •≥18 years of age up to 90 years old.
  • •Eligible and referred for cardiac device implantation.
  • •BMI < 35.

排除标准

  • •Unable to sign consent.
  • •Patient eligible for cardiac device upgrades/ extractions, subcutaneous implantable cardioverter defibrillators (SICD) & leadless devices.

研究组 & 干预措施

US Guided Axillary venous access

Experimental

Physician/ provider will perform 2 unassisted & 10 solo Ultrasound (US) guided venous access and pocket creation cardiac device implant. First 2 device implant will be done to educate physicians about ultrasound guided venous access. Subsequent subject will be randomized to 2:1 in ultrasound vs. conventional technique.

干预措施: Ultrasound guided venous access (Procedure)

Conventional technique

Active Comparator

Physician/ provider will perform 5 cardiac device implant using conventional technique for venous access and pocket creation.

干预措施: Conventional technique (Procedure)

结局指标

主要结局

Venous access time between US guided and conventional technique

时间窗: During procedure

Assess changes in venous access and pocket creation time with progressive experience with US guided axillary venous access (learning curve).

Time spent for pocket creation between US guided venous access technique and conventional technique.

时间窗: During procedure

Compare the pocket creation time with US guided axillary venous access versus conventional techniques.

Time spent to obtain venous access & pocket creation between experienced and inexperienced physicians.

时间窗: During procedure

Compare venous access and pocket creation time amongst experienced and inexperienced physicians.

To assess 30 day post procedure complications

时间窗: 30 Day post procedure

Assess 30-day complications between techniques.

Assess acute procedural success between two techniques.

时间窗: During procedure

Compare overall procedural success whether device was successfully placed or not post procedure between US guided axillary venous access \& conventional technique. Success as Assigned- whether implant technique assigned was successful or whether had to switch to an alternative technique.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Seth Sheldon

Clinical Assistant Professor of Medicine - Cardiology, Principal Investigator

University of Kansas Medical Center

研究点 (1)

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