Clinical Research Directory

In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial

Sponsor: The First Hospital of Jilin University

Summary

Background: Ultrasound guidance is an important technique to improve the success rate of internal jugular vein catheterization (IJVC) at the first-attempt, however, both long-axis in-plane and short-axis out-of-plane techniques have their own disadvantages. The T-shaped ultrasonic probe invented by us combined with the help of laser positioning and 3D printing manipulator could realize real-time bi-plane guidance of the needle short-axis out-of-plane and long-axis in-plane. With the help of the Single-operator Laser-assisted T-shaped probe, the whole process of needle insertion, guide wire placement and catheter placement can be visualized, which is expected to improve the success rate on the first-attempt. Objective: The primary outcome was the first-attempt success rate of initial RIJV catheterization without complications. The completion of the catheterization was defined as the presentation of the CVP waveform on the monitor. The secondary outcomes included first-attempt puncture success rate,first-attempt catheterisation success rate,overall catheterisation success rate,first-attempt needle tip location,first-attempt needle tip midline placement rate,number of needle direction adjustments,number of ultrasound probe repositionings, number of puncture attempts,first-attempt localisation time,first-attempt guidewire insertion success time,overall catheterisation success time. Design, Setting, and Participants: This single-center, prospective, parallel-group, randomized controlled study enrolled surgical patients over 18 years and older (ASA grade Ⅰ-Ⅳ) who required IJVC ,fully understands the benefits and risks of the study, participates voluntarily, and signs the informed consent form in the First Hospital of Jilin University. The exclusion criteria were congenital abnormal development of the internal jugular vein; prior puncture at the same site last month; puncture site injury, infection, or hematoma; right neck surgery history and neck fixation due to surgery or injury. The participants were randomized into the traditional ultrasound-guidance group or the single-operator Laser-assisted T-shaped probe ultrasound-guidance group. After inducing general anesthesia, ultrasound-guided internal jugular vein catheterization was performed by the experienced operators. Interventions: 352 patients were stratified into eight subgroups based on whether common carotid artery coverage exceeded 50% ,internal jugular vein depth exceeded 10mm , and internal jugular vein anteroposterior diameter exceeded 10mm . Each subgroup generated an independent randomisation sequence according to the block randomisation principle (T-mode ultrasound-guided group and 'long-axis plane' ultrasound-guided group). Upon enrolment, new subjects were assigned to corresponding subgroups based on stratification factors. Within each subgroup's dedicated random sequence, the allocation plan (T-shaped ultrasound guidance group or 'long-axis plane' ultrasound guidance group) was sequentially retrieved and marked. The next subject in that subgroup would receive the subsequent plan in the sequence. The operating team comprised six physicians (including two residents, two specialists, and two anaesthesiologists), who were not involved in other aspects of the study. Given the significant technical differences between the two approaches, the operators, equipment assistants, and research assistants were aware of the groupings. Conversely, participants' families were unaware of the groupings and could withdraw from the trial at any time. All data were collected and analysed by the same research assistant.

Official title: In-plane Versus Real-time Bi-plane Single-operator Laser-assisted With an Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization: A Randomized Clinical Trial

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