Multiple Trauma/InjuriesUAVCTNCT05896735
Ultrasound-guided Axillary Vein Catheterization in Trauma
An observational study of Multiple Trauma/Injuries, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 0 to 100 years
- Conditions the study is for
- Multiple Trauma/Injuries
- What is being tested?
- Ultrasound-guided axillary vein catheterization
- Type of treatment
- Surgery or procedure
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Our study do not consider limits on age, sex, or pregnant.
Who may be able to join
- Trauma patients admitted to TICU
- Receiving axillary vein catheterization during TICU stay
Who cannot join
- Without record of axillary vein catheterization
- Without imaging confirming （X-ray or chest CT） the location of catheter tip
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310009
Shou-Yin Jiang, PhD., 86-15988854485, jansoean@zju.edu.cn
About this study
Official title: 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.
- Conditions
- Multiple Trauma/Injuries
- Being tested
- Ultrasound-guided axillary vein catheterization
- Keywords
- multiple trauma, axillary vein catheterization, intensive care unit, complications
- Medical subject headings
- Multiple Trauma, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided axillary vein catheterizationProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2021-10-1~2023-04-30
Secondary outcomes (5)
Puncture complications after axillary vein catheterization
Pneumothorax, thrombus, artery injury, local infection, catheter-related infection
Measured: 2021-10-1~2023-04-30
Thromboembolism events
Incidents of thromboembolism events after axillary vein catheterization during TICU stay
Measured: 2021-10-1~2023-04-30
TICU mortality
Death rate during TICU stay
Measured: 2021-10-1~2023-04-30
TICU length of stay
Time (d) spent during TICU therapy
Measured: 2021-10-1~2023-04-30
Ventilator support
Duration of ventilator support during TICU stay
Measured: 2021-10-1~2023-04-30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start25 Apr 2023
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple Trauma/InjuriesStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shou-Yin Jiang, PhD., Principal investigator, 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896735
- Sponsor's protocol ID
- 2023-0364
- Acronym
- UAVCT
- Status last verified
- Apr 2023
- First submitted
- 2 May 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 36316830Su 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.
PubMed 32643012He 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.
PubMed 28523170Wang 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.
PubMed 32114875
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Axillary Vein Catheterization in the Trauma Intensive Care Unit: A Single-Center Retrospective Study
- ClinicalTrials.gov ID
- NCT05896735
- Acronym / sponsor ID
- UAVCT / 2023-0364
- Conditions
- Multiple Trauma/Injuries
- Keywords
- multiple trauma, axillary vein catheterization, intensive care unit, complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Our study do not consider limits on age, sex, or pregnant.
Key inclusion criteria (2 listed)
- Trauma patients admitted to TICU
- Receiving axillary vein catheterization during TICU stay
Key exclusion criteria (2 listed)
- Without record of axillary vein catheterization
- Without imaging confirming （X-ray or chest CT） the location of catheter tip
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided axillary vein catheterizationAll 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. | Procedure or surgery | – |
Primary outcome
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.
5 secondary outcomes
Puncture complications after axillary vein catheterization
Time frame: 2021-10-1~2023-04-30
Thromboembolism events
Time frame: 2021-10-1~2023-04-30
TICU mortality
Time frame: 2021-10-1~2023-04-30
TICU length of stay
Time frame: 2021-10-1~2023-04-30
Ventilator support
Time frame: 2021-10-1~2023-04-30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Results publication: PubMed 36316830Zhou 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.
- Results publication: PubMed 32643012Su 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.
- Results publication: PubMed 28523170He 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.
- Results publication: PubMed 32114875Wang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shou-Yin Jiang, PhD. principal investigator
2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Trauma/Injuries, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shou-Yin Jiang, PhD. (86-15988854485, jansoean@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accurate placement of the CVC catheter tip for measuring CVP or invasive hemodynamic monitoring (time frame: 2021-10-1~2023-04-30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05896735, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.