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NCT Number: NCT07079904

Laser-assisted Ultrasound-guided Peripheral Vein Cannulation in Cardiac Surgery

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ultrasound Guided Peripheral Vein Catheterization With or Without Laser-Assisted.

Other

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

Primary outcomes

  1. First-attempt success rate

    Time frame: immediately after the intervention

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

Secondary outcomes

  1. The overall rate of successful catheterizations The overall rate of successful catheterizations

    Time frame: immediately after the intervention

    Counted at the completion of the procedure and calculated during the data collation phase

  2. The number of unintentional penetration of the posterior wall of the venous

    Time frame: From the beginning of puncture to completion of catheterization

    Counted during the procedure and calculated during the data collation phase

  3. The procedure time to success within the first attempt

    Time frame: From the beginning of puncture to completion of catheterization in the first attempt

    Counted during the procedure

  4. Overall procedure time

    Time frame: immediately after the procedure

    Counted during the procedure and calculated during the data collation phase

  5. The average number of adjustments

    Time frame: From the beginning of puncture to completion of catheterization

    Counted during the procedure and calculated during the data collation phase

  6. The midmost rate of first attempt

    Time frame: After the first needle insertion

    Ultrasound images were stored and evaluated after the whole procedure.

  7. The first needle-tip position

    Time frame: After the first needle insertion

    Ultrasonic images were stored and evaluated by quadrant method after the whole procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Shuai Wang

CONTACT

[email protected]

+8618852095101

YING ZHANG

CONTACT

025-52271064

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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