跳至主要内容
临床试验/NCT07079904
NCT07079904招募中不适用

Comparison of Single Operator Laser-assisted Ultrasound-guided Peripheral Vein Cannulation With Traditional Ultrasound Guidance in Patients Receiving Cardiac Surgery

Nanjing First Hospital, Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年7月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
First-attempt success rate

研究概览

简要总结

The aim of this clinical trial is to investigate the advantages of single-operator laser-assisted ultrasound-guidance comparing with traditional ultrasound guidance in peripheral venous catheterization.The primary question addressed is whether single-operator laser-assisted ultrasound-guidance could improve the first-attempt success rate of peripheral venous catheterization compared with traditional ultrasound guidance.

详细描述

One hundred patients receiving cardiac surgery were randomized into two groups control group (group T, 50 patients), and experimental group (group L, 50 patients). In group T, ultrasound-guided short-axis out-of-plane technique with dynamic needle tip positioning is employed. The operator holds the puncture needle in the right hand at an angle of approximately 30-40° to the skin, and inserts the needle along the projection path of the laser on the body surface at a distance of about 0.5 cm from the probe. Under direct visualization, the needle tip is inserted into the blood vessel, and then the probe is slowly moved along the course of the vein to keep the needle tip directly above the vessel, thereby obtaining the optimal axial cross-section with this as the axis. After observing the high-echo needle tip displayed in the blood vessel on the ultrasound image, keep the puncture needle still and move the ultrasound probe until it disappears. Slowly advance the puncture needle so that the needle tip is always located in the center of the blood vessel during the puncture process. After observing the needle body reaching the blood vessel, withdraw the needle core, and then insert the catheter into it. In group L, an nurse prepares the equipment as follows before the patient enters the operating room: the mechanical arm is fixed near the operating table, and the laser emitter is attached is attached nearby. The tightness is adjusted to ensure a tighter fit between the probe and its housing. The ultrasound probe is then placed over the middle of the elbow and slightly moved so that the central auxiliary line on the screen passes through the center of the blood vessel. After the image is saved, another nurse measures the diameter and depth of the vein. The first point under the middle of the ultrasound probe is marked with a sterile marker pen. The probe is then moved 1.0 cm proximally, and the second point is marked in the same way. The probe is fixed to the skin at an angle of approximately 75°. After turning on the laser, the laser beam is aligned to pass through the middle mark of the ultrasound probe (centered on the vein lumen) and the two marked points: the laser beam thus becomes the skin projection of the venous anatomical path. At this point, the probe is fixed with the mechanical arm, and the needle is held in the right hand. Finally, the height of the ultrasound screen is adjusted to be level with the operator's eyes to reduce head and neck movement and facilitate guidance. Then, venous catheterization was completed with the "dynamic needle tip positioning" method.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •aged 18-80 years
  • •BMI 18-30 kg/m²
  • •ASA classification 1-4

排除标准

  • •infection or hematoma at the puncture site
  • •patients mentally unstable or unable to cooperate
  • •patient refused to participate

研究组 & 干预措施

Group T

Other

In group T, ultrasound-guided peripheral vein cannulation was performed using dynamic needle tip positioning technique.

干预措施: Ultrasound Guided Peripheral Vein Catheterization With or Without Laser-Assisted. (Other)

Group L

Experimental

In group L, ultrasound-guided peripheral vein cannulation was performed using dynamic needle tip positioning technique with laser-assisted.

干预措施: Ultrasound Guided Peripheral Vein Catheterization With or Without Laser-Assisted. (Other)

结局指标

主要结局

First-attempt success rate

时间窗: immediately after the intervention

The completion of the cannulation was defined as the presentation of the arterial waveform on the monitor.

次要结局

  • The overall rate of successful catheterizations The overall rate of successful catheterizations(immediately after the intervention)
  • The number of unintentional penetration of the posterior wall of the venous(From the beginning of puncture to completion of catheterization)
  • The procedure time to success within the first attempt(From the beginning of puncture to completion of catheterization in the first attempt)
  • Overall procedure time(immediately after the procedure)
  • The average number of adjustments(From the beginning of puncture to completion of catheterization)
  • The midmost rate of first attempt(After the first needle insertion)
  • The first needle-tip position(After the first needle insertion)

研究者

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

Shuai Wang

Deputy Chief Nurse

Nanjing First Hospital, Nanjing Medical University

研究点 (1)

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