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

NCT07079904 | Recruiting DMC

• 1 other identifier: KY20250527-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 first-attempt success rate of peripheral venous catheterization compared with traditional ultrasound guidance.

Conditions

Ultrasonography, Interventional

Outcome Measures

Primary Outcomes (1)

• First-attempt success rate

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

  immediately after the intervention

Secondary Outcomes (7)

• The overall rate of successful catheterizations The overall rate of successful catheterizations

  immediately after the intervention

• The number of unintentional penetration of the posterior wall of the venous

  From the beginning of puncture to completion of catheterization

• The procedure time to success within the first attempt

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

• Overall procedure time

  immediately after the procedure

• The average number of adjustments

  From the beginning of puncture to completion of catheterization

Study Arms (2)

Group T

OTHER

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

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.

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

Interventions

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.

Group L; Group T

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

Study Officials

• Shuai Wang

  Nanjing First Hospital, Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Shuai Wang

CONTACT

+8618852095101; wangshuaisj@126.com

YING ZHANG

CONTACT

025-52271064

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Nurse

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 23, 2025
• Study Start: July 24, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)