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.
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
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Shuai Wang, +8618951670945, wangshuaisj@126.com
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.
- Conditions
- Ultrasonography, Interventional
- 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 group | Role | What they receive |
|---|---|---|
| Group T | Other | In 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 L | Experimental | In 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.
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)
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
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
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
Overall procedure time
Counted during the procedure and calculated during the data collation phase
Measured: immediately after the procedure
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
The midmost rate of first attempt
Ultrasound images were stored and evaluated after the whole procedure.
Measured: After the first needle insertion
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.
- First posted23 Jul 2025
- Study start24 Jul 2025
- Primary completion21 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasonography, InterventionalStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuai Wang, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Shuai Wang, Study chair, Nanjing First Hospital, Nanjing Medical University
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Single Operator Laser-assisted Ultrasound-guided Peripheral Vein Cannulation With Traditional Ultrasound Guidance in Patients Receiving Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07079904
- Acronym / sponsor ID
- KY20250527-01
- Conditions
- Ultrasonography, Interventional
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 21 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group T | Other | Other: Ultrasound Guided Peripheral Vein Catheterization With or Without Laser-Assisted.In group T, ultrasound-guided peripheral vein cannulation was performed using dynamic needle tip positioning technique. |
| Group L | Experimental | Other: Ultrasound Guided Peripheral Vein Catheterization With or Without Laser-Assisted.In group L, ultrasound-guided peripheral vein cannulation was performed using dynamic needle tip positioning technique with laser-assisted. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18-80 years
- BMI 18-30 kg/m²
- ASA classification 1-4
Key exclusion criteria (3 listed)
- infection or hematoma at the puncture site
- patients mentally unstable or unable to cooperate
- patient refused to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound Guided Peripheral Vein Catheterization With or Without Laser-Assisted.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. | Other | Group L, Group T |
Primary outcome
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.
7 secondary outcomes
The overall rate of successful catheterizations The overall rate of successful catheterizations
Time frame: immediately after the intervention
The number of unintentional penetration of the posterior wall of the venous
Time frame: From the beginning of puncture to completion of catheterization
The procedure time to success within the first attempt
Time frame: From the beginning of puncture to completion of catheterization in the first attempt
Overall procedure time
Time frame: immediately after the procedure
The average number of adjustments
Time frame: From the beginning of puncture to completion of catheterization
The midmost rate of first attempt
Time frame: After the first needle insertion
The first needle-tip position
Time frame: After the first needle insertion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
YING ZHANG contact
Shuai Wang study chair
Nanjing First Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
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.