Facilitating Needle Alignment With Aiming Method

Study Overview
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Brief Summary
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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.

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

Conditions
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Central Venous Catheters

Intervention / Treatment
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* Procedure: subclavian vein catheterization
* Procedure: landmark techniques
* Procedure: Ultrasound-guided plus needle guide techniques


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: landmark techniques<br>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<br>* 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.<br>|
| Experimental: ultrasound-guided with aiming method<br>Subclavian vein catheterization is performed with our newly proposed aiming method with the guidance of ultrasound. | Procedure: subclavian vein catheterization<br>* 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.<br>|
| Experimental: ultrasound-guided plus needle guide techniques<br>Subclavian vein catheterization is performed under ultrasound guidance with in-plane technique. | Procedure: Ultrasound-guided plus needle guide techniques<br>* 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.<br>|

What is the study measuring?
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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 |