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临床试验/NCT04245553
NCT04245553已完成不适用

Does Point of Care Ultrasound Change Needle Insertion Location During Routine Bedside Paracentesis?

Steven Montague2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2020年2月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
2
主要终点
Preference of land-marking method

研究概览

简要总结

Paracentesis is a bedside procedure in which a needle is inserted into a patient's peritoneum in order to obtain ascitic fluid. This is a safe bedside procedure with very low risks of complications that is usually performed using physical exam maneuvers to determine the site of needle insertion. Point of care ultrasound (POCUS) technology has improved the safety of central venous catheter insertion and thoracentesis, yet the data on safety in paracentesis is equivocal. In a practical study, we aim to determine if POCUS will change the needle insertion site over the traditional anatomic landmarking method. Operators will landmark for paracentesis using conventional physical exam and then utilize POCUS to determine if there is a more optimal site. The primary endpoint will be whether POCUS yielded a change in the needle insertion site, as defined by a location greater than 5cm from the anatomic site, at least 20% of the time. The results will further our understanding of POCUS in improving procedural safety, thereby adding to the currently limited literature on this topic. Furthermore, this study will inform residency training programs about the utility in POCUS training for paracentesis and may advocate for the availability of POCUS devices to physicians performing this procedure.

研究设计

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

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants scheduled to have either a diagnostic of therapeutic paracentesis.
  • Participants can be either inpatients under the care of general internal medicine, or outpatients under the care of gastroenterology or general internal medicine.
  • Operators will be recruited on a volunteer basis and will include medical residents or subspecialty fellows with knowledge of POCUS for paracentesis purposes, either through core residency programs or more advanced training.

排除标准

  • Loculated ascites
  • Current anticoagulation
  • Hemodynamic instability
  • Bowel obstruction
  • Pregnancy
  • Abdominal wall cellulitis
  • Platelet count <20

结局指标

主要结局

Preference of land-marking method

时间窗: Determined immediatly after the POCUS landmarking is done.

Does the clinician performing the procedure prefer the needle insertion site found using point of care ultrasound, or using the traditional anatomic method. A clinically significant difference in location is defined as greater than or equal to 5cm apart. If the difference in locations is not at least 5cm apart, this will be defined as no preference in land-marking methods.

次要结局

  • Depth of Ascitis(Determined immediatly after the POCUS landmarking is done.)
  • Immediate Complications(Occuring at any time between the needle insertion and removal of the paracentesis drain.)

研究者

发起方
Steven Montague
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Steven Montague

Medical Doctor, Assistant Professor

Queen's University

研究点 (2)

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