NCT06652191|Unknown
Non Dilation on the Central Venous Catheterization（NDCVC-01）
NDCVC-01
Effect of Central Venous Puncture Dilation and Non Dilation on the Success Rate of Catheterization
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NDCVC-01
Effect of Central Venous Puncture Dilation and Non Dilation on the Success Rate of Catheterization
Sponsor study identifier
interventional
336
1 country
1
Study Start
October 28, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The central venous catheter is widely used and used in high dosage, and various complications such as hematoma, hemopneumothorax and arterial puncture may occur during puncture and use. In addition to conventional techniques, studies have been done to improve the success rate of puncture and reduce the incidence of complications by modifying different procedures. However, among the complications caused by the procedure of percutaneous catheter placement, the fatal bleeding caused by skin dilation may threaten the patient' s life. There are few studies on dilators and skin dilation steps at home and abroad. In this study, the conventional puncture technique was improved and the skin dilation step was omitted, hoping to reduce complications, reduce puncture time, improve efficiency and improve patient comfort on the premise of ensuring the success rate of catheterization.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 21, 2024
Actual (reported)October 22, 2024
Actual (reported)October 28, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Success Rate of Catheterization
The ratio of the number of successful catheterization to the number of participants in each group. Confirm that the catheter in the target vessel is defined as:(1)The syringe smoothly draws back blood;(2)After the fluid is connected, the infusion drops flow smoothly
Intraoperative (Start by locating the vessel until the catheter is confirmed to be in the target vessel)
Total time of catheterization
Intraoperative (Start with the tip of the needle touching the skin until the catheter is in the target) vessel
Incidence of immediate complications
Intraoperative (Start by locating the vessel until the catheter is confirmed to be in the target vessel)
Patient Comfort Score
24 hours after catheterization
Under the guidance of real-time ultrasound, the right internal jugular vein was punctured and a guide wire was inserted, place the catheter into the vessel directly along the guide wire without using an dilator to expand the skin
Under the guidance of real-time ultrasound, the right internal jugular vein was punctured and a guide wire was inserted, after the skin is expanded with a dilator, the catheter is inserted into the vessel along the guide wire
Under the guidance of real-time ultrasound, the right internal jugular vein was punctured and a guide wire was inserted, place the catheter into the vessel directly along the guide wire without using an dilator to expand the skin
Under the guidance of real-time ultrasound, the right internal jugular vein was punctured and a guide wire was inserted, after the skin is expanded with a dilator, the catheter is inserted into the vessel along the guide wire
the Sixth Affiliated Hostipal, Sun Yet Sen University
Guangzhou, Guangdong, 510655, China
iData Research. Central Venous Catheter Market Size, Share & Trends Analysis, Global, 2020-2026. 2020. Accessed October 26, 2023
秦志均,等.改良中心静脉穿刺术对穿刺置管并发症的影响.现代临床医学2016( 04) :023
Collier PE. Prevention and treatment of dilator injuries during central venous catheter placement. J Vasc Surg Venous Lymphat Disord. 2019 Nov;7(6):789-792. doi: 10.1016/j.jvsv.2019.06.020. Epub 2019 Aug 27.
Kulvatunyou N, Heard SO, Bankey PE. A subclavian artery injury, secondary to internal jugular vein cannulation, is a predictable right-sided phenomenon. Anesth Analg. 2002 Sep;95(3):564-6, table of contents. doi: 10.1097/00000539-200209000-00012.
Sanqing Jin, MD
Sixth Affiliated Hospital, Sun Yat-sen University
First Submitted
October 21, 2024
First Posted
October 22, 2024
Study Start
October 28, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 31, 2025
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Oropello JM, Leibowitz AB, Manasia A, Del Guidice R, Benjamin E. Dilator-associated complications of central vein catheter insertion: possible mechanisms of injury and suggestions for prevention. J Cardiothorac Vasc Anesth. 1996 Aug;10(5):634-7. doi: 10.1016/s1053-0770(96)80142-x. No abstract available.
Adhya S, Laha SK. Central venous catheterization. N Engl J Med. 2007 Aug 30;357(9):944; author reply 944-5. No abstract available.
Safety Committee of Japanese Society of Anesthesiologists. Practical guide for safe central venous catheterization and management 2017. J Anesth. 2020 Apr;34(2):167-186. doi: 10.1007/s00540-019-02702-9. Epub 2019 Nov 30.
Hind D, Calvert N, McWilliams R, Davidson A, Paisley S, Beverley C, Thomas S. Ultrasonic locating devices for central venous cannulation: meta-analysis. BMJ. 2003 Aug 16;327(7411):361. doi: 10.1136/bmj.327.7411.361.
Lim T, Ryu HG, Jung CW, Jeon Y, Bahk JH. Effect of the bevel direction of puncture needle on success rate and complications during internal jugular vein catheterization. Crit Care Med. 2012 Feb;40(2):491-4. doi: 10.1097/CCM.0b013e318232da48.
Lee YH, Kim TK, Jung YS, Cho YJ, Yoon S, Seo JH, Jeon Y, Bahk JH, Hong DM. Comparison of Needle Insertion and Guidewire Placement Techniques During Internal Jugular Vein Catheterization: The Thin-Wall Introducer Needle Technique Versus the Cannula-Over-Needle Technique. Crit Care Med. 2015 Oct;43(10):2112-6. doi: 10.1097/CCM.0000000000001167.
Kim E, Kim BG, Lim YJ, Jeon YT, Hwang JW, Kim HC, Choi YH, Park HP. A prospective randomised trial comparing insertion success rate and incidence of catheterisation-related complications for subclavian venous catheterisation using a thin-walled introducer needle or a catheter-over-needle technique. Anaesthesia. 2016 Sep;71(9):1030-6. doi: 10.1111/anae.13543. Epub 2016 Jul 11.
Song IK, Kim EH, Lee JH, Jang YE, Kim HS, Kim JT. Seldinger vs modified Seldinger techniques for ultrasound-guided central venous catheterisation in neonates: a randomised controlled trial. Br J Anaesth. 2018 Dec;121(6):1332-1337. doi: 10.1016/j.bja.2018.08.008. Epub 2018 Sep 7.
Teja B, Bosch NA, Diep C, Pereira TV, Mauricio P, Sklar MC, Sankar A, Wijeysundera HC, Saskin R, Walkey A, Wijeysundera DN, Wunsch H. Complication Rates of Central Venous Catheters: A Systematic Review and Meta-Analysis. JAMA Intern Med. 2024 May 1;184(5):474-482. doi: 10.1001/jamainternmed.2023.8232.
McGee DC, Gould MK. Preventing complications of central venous catheterization. N Engl J Med. 2003 Mar 20;348(12):1123-33. doi: 10.1056/NEJMra011883. No abstract available.
Smith RN, Nolan JP. Central venous catheters. BMJ. 2013 Nov 11;347:f6570. doi: 10.1136/bmj.f6570. No abstract available.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 22, 2024
Record last verified: 2024-07
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Source: ClinicalTrials.gov.
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