Facilitating Needle Alignment With Aiming Method

Aiming Method May Facilitate Needle Alignment in Ultrasound-guided Subclavian Vein Catheterization

Although ultrasound-guided catheterization of the subclavian vein is becoming standard procedure in anesthetic practice, failure to align the needle and the transducer still can lead to possibly complications. In this study, we proposed a new alignment method, namely Aiming Method. The purpose of this study is to investigate whether the use of this aiming method improved resident volunteers' performance of ultrasound-guided SC insertion in real patients. Specifically, residents were asked to perform three different methods: landmark techniques, ultrasound-guided with aiming method and ultrasound-guided plus needle guide techniques.

Study Overview

• Status: Completed
• Conditions: Central Venous Catheters
• Intervention / Treatment: Procedure: landmark techniques; Procedure: subclavian vein catheterization; Procedure: Ultrasound-guided plus needle guide techniques

• Study Type: Interventional
• Enrollment (Actual): 474
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing, China, 400042
    • Daping Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years to 70 years
• American Society of Anesthesiologists (ASA) Physical Status Ⅰ-Ⅲ
• Elective surgery patients requiring subclavian vein catheterization

Exclusion Criteria:

• Local anatomic abnormalities in subclavicular area
• Preexisting subclavian vein thrombosis or coagulation disorders
• Refusal of subclavian vein catheterization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: landmark techniques; Subclavian vein catheterization is performed without the guidance of ultrasound. The needle was inserted 1 cm inferior and 1 cm lateral to the junction of the middle and medial thirds of the clavicle (infraclavicular approach)	Procedure: landmark techniques; The patient is positioned in Tredelenburg with the arm abducted to 90°. Venipuncture should occur 1 cm lateral to the curvature of the middle third of the clavicle with the needle pointing horizontally directed at the sternal notch. If subclavian vein is missing at the first try, withdraw the needle and direct horizontally at the cricoid cartilage at the second try.
Experimental: ultrasound-guided with aiming method; Subclavian vein catheterization is performed with our newly proposed aiming method with the guidance of ultrasound.	Procedure: subclavian vein catheterization; Here we introduced a new freehand method, named as Aiming Method, which facilitated the alignment of injection needles with ultrasound beams. During this aiming method, patient is still positioned in Tredelenburg with the arm abducted to 90° and no needle guidance will be used.
Experimental: ultrasound-guided plus needle guide techniques; Subclavian vein catheterization is performed under ultrasound guidance with in-plane technique.	Procedure: Ultrasound-guided plus needle guide techniques; Subclavian vein catheterization is performed under ultrasound guidance with in-plane technique. The patient is positioned in Tredelenburg with the arm abducted to 90°. During the needle insertion, the needle is secured in the needle guidance device which keeps the alignment of needle and ultrasonic beam.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural time	the time from skin break to guide wire was positioned into the subclavian vein	24 hours
Number of skin breaks	number of skin punctures	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of arterial puncture	aspiration of arterial blood during needle insertion or local haematoma in ultrasound image	24 hours
The incidence of pneumothorax	aspiration of air during needle insertion, or thoracic ultrasonography, or chest radiography	24 hours

Collaborators and Investigators

• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2019
• Primary Completion (Actual): December 20, 2019
• Study Completion (Actual): December 27, 2019

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: December 14, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 20, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2018(45)

Drug and device information, study documents

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