- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05896735
Ultrasound-guided Axillary Vein Catheterization in Trauma (UAVCT)
June 12, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
Ultrasound-guided Axillary Vein Catheterization in the Trauma Intensive Care Unit: A Single-Center Retrospective Study
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
132
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shou-Yin Jiang, PhD.
- Phone Number: 86-15988854485
- Email: jansoean@zju.edu.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310009
- Recruiting
- 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
-
Contact:
- Shou-Yin Jiang, PhD.
- Phone Number: 86-15988854485
- Email: jansoean@zju.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Our study do not consider limits on age, sex, or pregnant.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accurate placement of the CVC catheter tip for measuring CVP or invasive hemodynamic monitoring
Time Frame: 2021-10-1~2023-04-30
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Puncture complications after axillary vein catheterization
Time Frame: 2021-10-1~2023-04-30
|
Pneumothorax, thrombus, artery injury, local infection, catheter-related infection
|
2021-10-1~2023-04-30
|
|
TICU mortality
Time Frame: 2021-10-1~2023-04-30
|
Death rate during TICU stay
|
2021-10-1~2023-04-30
|
|
TICU length of stay
Time Frame: 2021-10-1~2023-04-30
|
Time (d) spent during TICU therapy
|
2021-10-1~2023-04-30
|
|
Ventilator support
Time Frame: 2021-10-1~2023-04-30
|
Duration of ventilator support during TICU stay
|
2021-10-1~2023-04-30
|
|
Thromboembolism events
Time Frame: 2021-10-1~2023-04-30
|
Incidents of thromboembolism events after axillary vein catheterization during TICU stay
|
2021-10-1~2023-04-30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shou-Yin Jiang, PhD., 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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):e31509. doi: 10.1097/MD.0000000000031509.
- 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 randomized controlled trial. Ann Intensive Care. 2020 Jul 8;10(1):90. doi: 10.1186/s13613-020-00703-6.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 25, 2023
Primary Completion (Estimated)
July 31, 2023
Study Completion (Estimated)
December 31, 2023
Study Registration Dates
First Submitted
May 2, 2023
First Submitted That Met QC Criteria
May 31, 2023
First Posted (Actual)
June 9, 2023
Study Record Updates
Last Update Posted (Actual)
June 13, 2023
Last Update Submitted That Met QC Criteria
June 12, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-0364
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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