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临床试验/NCT01742416
NCT01742416已完成不适用

Ultrasound Assisted Arterial Cannulation in Small Children - To See or Not to See?

The Hospital for Sick Children2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年11月最近更新:
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
40
试验地点
2
主要终点
Number of Attempts

研究概览

简要总结

Arterial cannulation is a commonly performed invasive procedure in the operation room, the emergency department, and in the intensive care unit. The indications include the need for continuous blood-pressure monitoring, frequent arterial blood-gas analysis, and repeated blood sampling for laboratory evaluation. This procedure can be challenging even in the best of hands. Traditionally, the artery is located by feeling the pulse of the patient. The pulse may, however be weak or absent in patients with hypotension, edema, obesity or local thrombosis due to previous arterial cannulation in the same location. Furthermore, the catheter may not be passed successfully into the artery, despite apparent good blood return on initial puncture, or hematoma and spasms of the artery may develop after failed attempts, thus making further attempts even more difficult. While ultrasound (US) is being used with increasing frequency for central venous access, fewer clinicians are familiar with US-guided arterial catheterization. The aim of this study is to investigate if ultrasound facilitates arterial cannulation in children ≤24 months compared with the palpation method and to investigate the potential extra costs/savings of introducing the method. This study hypothesizes that the ultrasound method will facilitate arterial cannulation in small children compared with the palpation method.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
1 Day 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children 24 months or younger
  • Children undergoing elective surgical procedures where arterial cannulation is planned by the attending anaesthetist. These procedures include cardiac surgery, craniotomies, cranial vault surgery, and some abdominal procedures.

排除标准

  • Refusal of consent from the parents
  • Refusal of participation from the anaesthetist
  • Children with anticipated circulatory instability after anaesthesia induction
  • Pulmonary hypertension defined as an estimated pulmonary arterial pressure which is greater than or equal to 66% of systemic blood pressure
  • Children with severe heart failure (right and/or left)

研究组 & 干预措施

Palpation Method

Active Comparator

干预措施: Palpation Method (Procedure)

Ultrasound

Experimental

干预措施: Ultrasound (Procedure)

结局指标

主要结局

Number of Attempts

时间窗: Change from baseline to successful cannulation (estimated average of 30 minutes)

To measure the number of attempts to cannulate the artery per participant.

次要结局

  • Time to Successful Cannulation(Change from baseline to successful cannulation (estimated average of 30 minutes))
  • Rate of Success of First Attempt(Change from baseline to success of first attempt, when artery is successfully cannulated on first attempt (estimated average of 30 minutes))
  • Learning Curve(At approximately 4 months)
  • Number of Attempted Sites(Change from baseline to successful cannulation (estimated average of 30 minutes))
  • Cost of Procedure(Duration of the study (6 months))

研究者

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

Katherine Taylor

Staff Anesthesiologist

The Hospital for Sick Children

研究点 (2)

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