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Ultrasonography, InterventionalNCT07079904

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

A study testing Ultrasound Guided Peripheral Vein Catheterization With or Without Laser-Assisted. in people with Ultrasonography, Interventional, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ultrasonography, Interventional
What is being tested?
Ultrasound Guided Peripheral Vein Catheterization With or Without Laser-Assisted.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
24 Jul 2025to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

YING ZHANG contact

025-52271064

China1 site, 1 recruiting
  • Nanjing First Hospital

    Nanjing, Jiangsu, 210006

    Shuai Wang, +8618951670945, wangshuaisj@126.com

    Recruiting

Other trials in China

About this study

Official title: Comparison of Single Operator Laser-assisted Ultrasound-guided Peripheral Vein Cannulation With Traditional Ultrasound Guidance in Patients Receiving 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.

Read the detailed description

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.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07079904
Study groupRoleWhat they receive
Group TOtherIn group T, ultrasound-guided peripheral vein cannulation was performed using dynamic needle tip positioning technique.
Receives: Other: Ultrasound Guided Peripheral Vein Catheterization With or Without Laser-Assisted.
Group LExperimentalIn group L, ultrasound-guided peripheral vein cannulation was performed using dynamic needle tip positioning technique with laser-assisted.
Receives: Other: Ultrasound Guided Peripheral Vein Catheterization With or Without Laser-Assisted.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. First-attempt success rate

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

    Measured: immediately after the intervention

Secondary outcomes (7)
  1. The overall rate of successful catheterizations The overall rate of successful catheterizations

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

    Measured: immediately after the intervention

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

    Counted during the procedure and calculated during the data collation phase

    Measured: From the beginning of puncture to completion of catheterization

  3. The procedure time to success within the first attempt

    Counted during the procedure

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

  4. Overall procedure time

    Counted during the procedure and calculated during the data collation phase

    Measured: immediately after the procedure

  5. The average number of adjustments

    Counted during the procedure and calculated during the data collation phase

    Measured: From the beginning of puncture to completion of catheterization

  6. The midmost rate of first attempt

    Ultrasound images were stored and evaluated after the whole procedure.

    Measured: After the first needle insertion

  7. The first needle-tip position

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

    Measured: After the first needle insertion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2025
  2. Study start24 Jul 2025
  3. Primary completion21 Nov 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07079904
Sponsor's protocol ID
KY20250527-01
Status last verified
Oct 2026
First submitted
7 Jul 2025
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound Guided Peripheral Vein Catheterization With or Without Laser-Assisted. in people with Ultrasonography, Interventional, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shuai Wang (+8618852095101, wangshuaisj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First-attempt success rate (time frame: immediately after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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