UAVCT: Ultrasound-guided Axillary Vein Catheterization in Trauma

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05896735
• Collaborator: (none)
• Enrollment: 132
• Location: 1
• Anticipated Duration (Months): 8.2
• Patients Per Site Per Month: 16.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Trauma/Injuries	Procedure: Ultrasound-guided axillary vein catheterization

Study Design

• Study Type: Observational
• Anticipated Enrollment: 132 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Ultrasound-guided Axillary Vein Catheterization in the Trauma Intensive Care Unit: A Single-Center Retrospective Study
• Actual Study Start Date: Apr 25, 2023
• Anticipated Primary Completion Date: Jul 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Outcome Measures

Primary Outcome Measures

1. Accurate placement of the CVC catheter tip for measuring CVP or invasive hemodynamic monitoring [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.

Secondary Outcome Measures

1. Puncture complications after axillary vein catheterization [2021-10-1~2023-04-30]

   Pneumothorax, thrombus, artery injury, local infection, catheter-related infection

2. Thromboembolism events [2021-10-1~2023-04-30]

   Incidents of thromboembolism events after axillary vein catheterization during TICU stay

3. TICU mortality [2021-10-1~2023-04-30]

   Death rate during TICU stay

4. TICU length of stay [2021-10-1~2023-04-30]

   Time (d) spent during TICU therapy

5. Ventilator support [2021-10-1~2023-04-30]

   Duration of ventilator support during TICU stay

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Hangzhou	Zhejiang	China	310009

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

• Principal Investigator: Shou-Yin Jiang, PhD., 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT05896735
• Other Study ID Numbers: 2023-0364
• First Posted: Jun 9, 2023
• Last Update Posted: Jun 13, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University: multiple trauma; axillary vein catheterization; intensive care unit; complications
• Additional relevant MeSH terms: Wounds and Injuries; Multiple Trauma

Study Results

No Results Posted as of Jun 13, 2023