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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05896735
Other study ID # 2023-0364
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 25, 2023
Est. completion date December 31, 2023

Study information

Verified date April 2023
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Shou-Yin Jiang, PhD.
Phone 86-15988854485
Email jansoean@zju.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

It is very important to choose the best central venous catheterization route for trauma patients, the determinants that need to be considered comprehensively include coagulation dysfunction, fracture of the clavicle on the side of the puncture, and tracheotomy care. More importantly, whether it can used simultaneously for accurate volume and invasive hemodynamic monitoring. For the purpose of support of cardiopulmonary function, the ideal position of the catheter tip is vital with regard to an accurate CVP and hemodynamic monitoring. Cannulation of the axillary vein is ideal for patients with severe poly-trauma because it avoids the thoracic cavity, intercostal arteries, tracheostomy, and clavicle, and is prone to compression even if the artery is injured. At present, there is no systematic introduction of ultrasound-guided axillary vein catheterization in the trauma ICU in the literature. Since Oct 2021, the investigators have attempted to practice axillary vein catheterization for this crucial trauma population; unfortunately, the investigators have not know till now whether this procedure is associated with accurate tip placement and its safety should also be weighted. So it is necessary to summarize the relevant clinical data.


Recruitment information / eligibility

Status Recruiting
Enrollment 132
Est. completion date December 31, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers No
Gender All
Age group 0 Years to 100 Years
Eligibility Inclusion Criteria: - Trauma patients admitted to TICU - Receiving axillary vein catheterization during TICU stay Exclusion Criteria: - Without record of axillary vein catheterization - Without imaging confirming (X-ray or chest CT) the location of catheter tip

Study Design


Intervention

Procedure:
Ultrasound-guided axillary vein catheterization
All axillary vein catheterizations were performed according to standard central venous catheterization procedures, which were performed under ultrasound guidance at the bedside. Before the operation, patients were placed in a supine position with the upper limb placed in a natural position, and the ultrasound probe and wires were wrapped with a sterile protective sheath. Ultrasound pre-scanning the axillary artery and axillary vein, and pay attention to using the minimum pressure to control the ultrasound probe to avoid crushing the blood vessels. The operator holds the ultrasound probe and puncture needle to puncture the axillary vein under the guidance of ultrasound. After drawing out of the dark red blood, the guide wire was inserted and the puncture needle was withdrawn. The three-lumen CVC catheter was then inserted using the Seldinger technique.

Locations

Country Name City State
China 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (4)

He YZ, Zhong M, Wu W, Song JQ, Zhu DM. A comparison of longitudinal and transverse approaches to ultrasound-guided axillary vein cannulation by experienced operators. J Thorac Dis. 2017 Apr;9(4):1133-1139. doi: 10.21037/jtd.2017.03.137. — View Citation

Su Y, Hou JY, Ma GG, Hao GW, Luo JC, Yu SJ, Liu K, Zheng JL, Xue Y, Luo Z, Tu GW. Comparison of the proximal and distal approaches for axillary vein catheterization under ultrasound guidance (PANDA) in cardiac surgery patients susceptible to bleeding: a r — View Citation

Wang HY, Sheng RM, Gao YD, Wang XM, Zhao WB. Ultrasound-guided proximal versus distal axillary vein puncture in elderly patients: A randomized controlled trial. J Vasc Access. 2020 Nov;21(6):854-860. doi: 10.1177/1129729820904866. Epub 2020 Mar 1. — View Citation

Zhou J, Wu L, Zhang C, Wang J, Liu Y, Ping L. Ultrasound guided axillary vein catheterization versus subclavian vein cannulation with landmark technique: A PRISMA-compliant systematic review and meta-analysis. Medicine (Baltimore). 2022 Oct 28;101(43):e31 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Accurate placement of the CVC catheter tip for measuring CVP or invasive hemodynamic monitoring Placement of the CVC catheter tip between level of tracheal carina and within 2 cm downward is ideal for measuring CVP or invasive hemodynamic monitoring. 2021-10-1~2023-04-30
Secondary Puncture complications after axillary vein catheterization Pneumothorax, thrombus, artery injury, local infection, catheter-related infection 2021-10-1~2023-04-30
Secondary Thromboembolism events Incidents of thromboembolism events after axillary vein catheterization during TICU stay 2021-10-1~2023-04-30
Secondary TICU mortality Death rate during TICU stay 2021-10-1~2023-04-30
Secondary TICU length of stay Time (d) spent during TICU therapy 2021-10-1~2023-04-30
Secondary Ventilator support Duration of ventilator support during TICU stay 2021-10-1~2023-04-30
See also
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Active, not recruiting NCT04074382 - FIT Study (Functional Outcomes In Trauma Study)
Completed NCT01523626 - A Multicenter, Randomized Study of Early Assessment by CT Scanning in Severely Injured Trauma Patients N/A