Does the Central Venous Puncture Needle Need to be 7 cm?

Does the Central Venous Puncture Needle Need to be 7 cm? ; Safety and Usefulness of Needle Length Adjustment Method Using Suture Wing

The central venous catheter (CVC) has been used for the first time in clinical use in 1921 and has been used worldwide by 2023. Although there are differences between studies, it is reported that side effects occur in approximately 5-20% of patients undergoing CVC. Common side effects include hematoma, venous puncture, arterial puncture, and pneumothorax, and horner syndrome is also reported in 5% of cases. In particular, in the case of the internal jugular vein (IJV), the possibility of puncture of the internal carotid artery is higher than that of other sites, and the puncture level also varies depending on the depth of needle insertion, which in some cases can cause very serious side effects. The incidence rate of side effects depends on the method of inserting the CVC and the skill of the operator. Previous method approached the IJV using the anatomy ladmark with the blind Seldinger technique, recently, as the use of ultrasound has become more common.

Ultra sound guided CVC insertion tecnique reduce the incidence of side effect. However, there are still major complications exist because less experiance operator inserts needle too deep without caution and only depends on the image of sonography.

Currently, the length of the needle commonly used in the CVC catheter set is 7 cm. In general, the depth from the skin to the IJV is within 1.5cm on either the right or the left, and under the premise that the needle insertion angle is 45 degrees, the distance from the skin to the IJV is within 2cm. Based on this, in previous studies, it was announced that the length of the needle required for IJV access was less than 4 cm.

The purpose of this study is to study the usefulness and safety of the method of sono-guided CVC catheter insertion by fixing the needle at a position 4 cm from the needle tip by placing the suture wing (18G, single catheter set).

Study Overview

• Status: Not yet recruiting
• Conditions: Central Venous Catheters
• Intervention / Treatment: Device: central venous catheter insertion

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ji young yoo; Phone Number: 01056902104; Email: anesyoo@aumc.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients who need CVC catheter for operation

Exclusion Criteria:

• Obesity (BMI > 35)
• wound or infection exist at the puncture site
• History of long term catheter placment in the IJV
• Abnormally small size or deformity of the IJV

• Past history of difiiculty in CVC catheterization

  • If the IJV is located at a depth of 3cm or more from theskin on ultrasound evaluation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: wing group

Device: central venous catheter insertion; All patients were under trendlenburg position (10 degrees) and disinfected for CVC catheterization. After attaching 2 suture wings of 18G single catheter set to the insertion needle in the 7 Fr or 8 Fr central catheter set, check the IJV to be punctured with an ultrasonic probe. The IJV is punctured using a cross sectional image confirmed at the cricoid cartilage level. After confirming the needle tip on the ultrasound image and blood coming out, the guide wire is mounted on the IJV and then a CVC catheter (arrow international INC) ., USA) is inserted. All actions are performed by a specialist who has more than 30 CVC catheterization experiences using ultrasound, and the occurrence of side effects and the time from puncture to guide wire entry are recorded by another researcher. After the procedure, the researcher who directly performed the procedure records the difficulty or difference compared to when using a conventional needle that does not have a suture wing installed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difficulty of catheterization	It would be evaluated by the operator who performed the catheterization. The severity of difficulty would be determined by total sum of the following scores.; needle tip visibility with sono: good (0), not good (1), bad(2); blood aspiration was during needle withdrawal :1; Number of attempt :1 ,2, 3 Total score would be ranged from 0 to 6	through study completion, an average of 10 minutes

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): May 27, 2023
• Primary Completion (Estimated): June 30, 2023
• Study Completion (Estimated): July 31, 2023

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: AJIRB-MED-INT-22-188

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No