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

October 21, 2024 updated by: Sixth Affiliated Hospital, Sun Yat-sen University

Effect of Central Venous Puncture Dilation and Non Dilation on the Success Rate of Catheterization

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

336

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The test group:Direct catheterization with non-dilation
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
Procedure: Direct catheterization with non-dilation
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
Active Comparator: The control group: Catheterization after expanding the skin with a dilator
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
Procedure: Catheterization after expanding the skin with a dilator
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success Rate of Catheterization
Time Frame: 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
Intraoperative (Start by locating the vessel until the catheter is confirmed to be in the target vessel)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total time of catheterization
Time Frame: 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
Intraoperative (Start with the tip of the needle touching the skin until the catheter is in the target) vessel
Incidence of immediate complications
Time Frame: 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.
Intraoperative (Start by locating the vessel until the catheter is confirmed to be in the target vessel)
Patient Comfort Score
Time Frame: 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.
24 hours after catheterization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

  • Principal Investigator: Sanqing Jin, MD, The Sixth Affiliated Hospital, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 28, 2024

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

October 21, 2024

First Submitted That Met QC Criteria

October 21, 2024

First Posted (Actual)

October 22, 2024

Study Record Updates

Last Update Posted (Actual)

October 22, 2024

Last Update Submitted That Met QC Criteria

October 21, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024ZSLYEC-387

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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