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

NCT06958731 | Enrolling By Invitation

• 1 other identifier: 2025-169
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Catheterization, Central Venous; Ultrasound Guided

Keywords

internal jugular vein catheterization; ultrasound guided

Outcome Measures

Primary Outcomes (1)

• the first-attempt success rate of internal jugular vein catheterization without complications

  perioperative/periprocedural

Secondary Outcomes (12)

• First-attempt puncture success rate

  perioperative/periprocedural

• Overall catheterization success rate

  perioperative/periprocedural

• First-attempt needle tip positioning score

  perioperative/periprocedural

• Midpoint accuracy rate of needle tip placement on first attempt

  perioperative/periprocedural

• Number of needle direction adjustments during puncture

  perioperative/periprocedural

Study Arms (2)

the single-operator Laser-assisted T-shaped probe ultrasound-guidance group

EXPERIMENTAL

Device: TuoRen Ultrasonic System

traditional ultrasound-guided in-plane group

EXPERIMENTAL

Device: Huasheng Color Ultrasonic Diagnostic System

Interventions

TuoRen Ultrasonic System DEVICE

The Single-operator Laser-assisted T-shaped probe consisted of TuoRen Ultrasonic System (TUR200, Shenzhen Tuoren Bio-Medical Electronics Co., LTD) with a T-shaped probe (L38T7C), a 3D-printed probe-carrying enclosure with a linear laser transmitter ( ZLM120AL650-22130BXS, Shenzhen Zhonglai Technology Co., Ltd.) and ultrasonic probe manipulator.

the single-operator Laser-assisted T-shaped probe ultrasound-guidance group

Huasheng Color Ultrasonic Diagnostic System DEVICE

Ultrasonic (Huasheng Color Ultrasonic Diagnostic System, Navi s, Shenzhen Huasheng Medical Technology Co., LTD.) and a 4.0MHz phased probe were used for the long-axis in-plane internal jugular vein catheterization

traditional ultrasound-guided in-plane group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient fully understood the benefits and risks of the study, voluntarily participated, and signed the informed consent form
• Require internal jugular vein catheterization
• ASA grade I\~IV
• Over 18 years and older

You may not qualify if:

• Congenital malformation or abnormal development of the internal jugular vein;
• Prior internal jugular vein catheterization performed within the past month
• Puncture site injury, infection, or hematoma
• History of surgical intervention in the right neck region
• Restricted neck mobility due to prior surgery or traumatic injury

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

the first hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: May 6, 2025
• Study Start: January 12, 2026
• Primary Completion: May 21, 2026
• Study Completion: June 1, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)