NCT05896735

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 2, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 13, 2023

Status Verified

April 1, 2023

Enrollment Period

3 months

First QC Date

May 2, 2023

Last Update Submit

June 12, 2023

Conditions

Keywords

multiple traumaaxillary vein catheterizationintensive care unitcomplications

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Puncture complications after axillary vein catheterization

    2021-10-1~2023-04-30

  • Thromboembolism events

    2021-10-1~2023-04-30

  • TICU mortality

    2021-10-1~2023-04-30

  • TICU length of stay

    2021-10-1~2023-04-30

  • Ventilator support

    2021-10-1~2023-04-30

Interventions

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.

Eligibility Criteria

Age0 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Our study do not consider limits on age, sex, or pregnant.

You may qualify if:

  • Trauma patients admitted to TICU
  • Receiving axillary vein catheterization during TICU stay

You may not qualify if:

  • Without record of axillary vein catheterization
  • Without imaging confirming (X-ray or chest CT) the location of catheter tip

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (4)

  • 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.

MeSH Terms

Conditions

Multiple TraumaWounds and Injuries

Study Officials

  • Shou-Yin Jiang, PhD.

    2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shou-Yin Jiang, PhD.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2023

First Posted

June 9, 2023

Study Start

April 25, 2023

Primary Completion

July 31, 2023

Study Completion

December 31, 2023

Last Updated

June 13, 2023

Record last verified: 2023-04

Locations