Non Dilation on the Central Venous Catheterization（NDCVC-01）

Not Applicable

Not yet recruiting

• Conditions: the Success Rate of Non Dilation on the Central Venous Catheterization

• Registration Number: NCT06652191
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief Summary

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.

Detailed Description

The Central venous catheter is widely used, but there are various complications. During the procedure of skin expansion with central venous catheterization, the use of a dilator can lead to complications such as hematoma, fatal bleeding, discomfort or serious threat to the patient's life. The aim of this study was to eliminate the procedure of skin expansion, to ensure the success rate of catheterization, to reduce complications, to reduce operation time, to improve efficiency, and to improve patients' comfort.

This study is a single-center, prospective, randomized controlled trial.The sample size was calculated by non-inferiority test:(1)the success rate of central venous catheterization was 97.98% according to Meta-analysis references;(2)α =0.025;(3)power 90%;(4)missed follow-up rate 20%, and ultimately 336 samples were included in the study,168 patients in each group.

Patients will receive written and verbal information about the trial before written consent is obtained. Randomization will take place on the day of surgery, and patients will be assigned to the intervention group (direct catheterization with non-dilation) or the control group (catheterization after expanding the skin with a dilator) . The randomization is performed using concealed allocation where envelopes are prepared externally using a randomization list prepared by a research assistant.

Under ultrasound guidance, The patient will undergo central venous catheterization by an experienced anesthesiologist based on grouping information.In the control group, catheter was inserted after skin expansion with dilator, while in the test group, catheter was inserted directly with non-dilator.The success rate of catheterization, the total time of catheterization, and complications were recorded.The patients were followed up for 24 hours after surgery and asked about their comfort level.

Shapiro-Wilk test is used to test normality for continuous variables, with data expressed as mean ± standard deviation, and independent t-test is used for statistical analysis.For categorical data, the incidence of immediate complications is expressed as a percentage (%), and chi square test is used to statistically analyze the incidence of various complications.For the Primary outcome ,success rate of catheterization, the method of confidence interval is used. If the lower limit of confidence interval \> negative non-inferiority threshold, the non-inferiority is considered. P \< 0.05 was considered statistically significant.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-21
• Last Update Submitted: 2024-10-21
• Study First Posted: 2024-10-22
• Last Update Posted: 2024-10-22
• Study Start: 2024-10-28
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

• (1) patients aged 18 years or older
• (2) patients with internal jugular vein catheterization

Exclusion Criteria

• （1）Patients with infection at the puncture site
• （2）Patients with contraindications to central venous catheterization
• （3）Patients with imaging examination suggesting thrombosis in the internal jugular vein before puncture
• （4）Patients who refused to participate, did not sign or refused to sign the informed consent form

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Success Rate of Catheterization	Intraoperative (Start by locating the vessel until the catheter is confirmed to be in the target vessel)	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

Secondary Outcome Measures

Name	Time	Method
Total time of catheterization	Intraoperative (Start with the tip of the needle touching the skin until the catheter is in the target) vessel	This total time was defined as the time from the tip of the needle touching the skin to confirmation that the catheter was 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)	immediate complications include：arterial puncture; pneumothorax; hemothorax; hematoma; Oozing blood; arrhythmia.; definition: Arterial puncture : puncture of an artery with a needle during catheter placement.; Pneumothorax :a collection of air or gas in the pleural cavity, which can cause the lung to collapse, confirmed by positive imaging.; Hemothorax: a collection of blood in the pleural cavity, which can cause the lung to collapse, confirmed by positive imaging.; hematoma: hematoma on the ultrasonography surrounding the vessel, severe hematoma defined as a visible hemotama large enough to be seen outside the skin.; Oozing blood: Blood oozes from the skin at the point of puncture, or requiring dressing change.; arrhythmia:a irregular heartbeat, include premature beats; atrial tachycardia; paroxysmal supraventricular tachycardia; atrial flutter; atrial fibrillation and so on.
Patient Comfort Score	24 hours after catheterization	Patients were assessed for comfort using the visual analogue scale(0-10). 0 was very uncomfortable, 10 was very comfortable, and the higher the score, the more comfortable the patient was.

Trial Locations

Locations (1)

the Sixth Affiliated Hostipal, Sun Yet Sen University; 🇨🇳 Guangzhou, Guangdong, China