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临床试验/NCT03523533
NCT03523533终止不适用

Peripherally Inserted Internal Jugular Catheters: an Observational Study

University of New Mexico1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2018年8月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
5
试验地点
1
主要终点
Catheter Placement Time

研究概览

简要总结

This is an observational study intended to characterize the time-to-placement of peripherally-inserted internal jugular (PIJ) catheters in appropriate patients. As secondary outcomes and to ensure patient safety, the investigators will record and evaluate adverse outcomes, but the study is not powered to detect rare events.

详细描述

This is an observational study with one arm. All enrolled patients will receive a peripheral angiocatheter in the internal jugular vein. Approximately 60 subjects will be enrolled.

After recruitment and consent, an investigator will place the peripherally-inserted jugular (PIJ) catheters for this study, under ultrasound guidance. Clean technique similar to that used for traditional peripheral intravenous catheters will be used, including chlorhexidine skin preparation, caps, and sterile ultrasound gel with sterile occlusive dressing over the ultrasound transducer. For patients included in this study because of a clinically-determined need for a second IV line, the catheter will be placed after anesthesia induction. Patients included because of difficult IV access will have the PIJ catheter placed prior to induction.

The size of the angiocatheter will be left to the clinical discretion of the investigator, from among these choices: 18G x 2.5 inches, 16G x 2 inches, or 14G x 2 inches. All angiocatheters will be radiopaque in order to permit visualization in the event of any required imaging. Catheters will be placed with visualization under dynamic ultrasonography using a Sonosite S-Nerve ultrasound machine with 13-6 MHz 25 mm linear array. All catheters and ultrasound components are being used in accordance with their labeling.

The depth of catheter insertion into the internal jugular vein will be determined, and the catheter will be removed/replaced immediately if it is found to extend less than 1.0 cm into the vessel. If the catheter is removed or replaced, routine care will be followed: pressure will be held until bleeding subsides and the site dressed appropriately (e.g. gauze with tape or adhesive bandage). No more than three attempts will be made before abandoning the effort to place a PIJ catheter.

The PIJ catheter will be secured as per normal practice, with an adhesive IV securing device and an occlusive bandage placed over both the IV and its securing device.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • •Adult elective-surgery patients at University of New Mexico Hospital main operating rooms, who do not require central venous catheters, and who either:
  • •require a second intravenous access line (IV) as determined by the anesthesiologist, *or*
  • •require a primary IV *and* are determined by the anesthesiologist to have difficult IV access, defined as two or more failed attempts at peripheral IV placement, in the absence of an indication for a central venous catheter.

排除标准

  • •Infection over the intended peripheral angiocatheter insertion site
  • •Cervical spine injury or instability
  • •Known abnormal neck anatomy
  • •Pregnancy
  • •Prisoners
  • •Clinical indication for central venous catheter
  • •Any pre-existing suspicion for bacteremia
  • •Adults unable to consent, as determined by ability to provide consent for surgery

研究组 & 干预措施

Peripherally-inserted internal jugular catheter

Experimental

All enrolled patients will receive a peripheral angiocatheter in the internal jugular vein, under dynamic ultrasound guidance.

干预措施: Angiocatheter (Procedure)

结局指标

主要结局

Catheter Placement Time

时间窗: No more than 20 minutes

Elapsed time from first contact of skin prep solution to completely secured/covered catheter

次要结局

  • Location of Insertion(No more than 20 minutes)
  • Number of Attempts(No more than 20 minutes)
  • Number of Participants Experiencing Catheter-related Complications(1 week)
  • Depth of Insertion(No more than 20 minutes)

研究者

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

Tony Yen

Associate Professor

University of New Mexico

研究点 (1)

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