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NCT Number: NCT03778437

Facilitating Needle Alignment With Aiming Method

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.

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Key information

Conditions

Central Venous Catheters

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daping Hospital

Chongqing, 400042, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

subclavian vein catheterization

Procedure

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.

landmark techniques

Procedure

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.

Ultrasound-guided plus needle guide techniques

Procedure

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.

Primary outcomes

  1. Procedural time

    Time frame: 24 hours

    the time from skin break to guide wire was positioned into the subclavian vein

  2. Number of skin breaks

    Time frame: 24 hours

    number of skin punctures

Secondary outcomes

  1. The incidence of arterial puncture

    Time frame: 24 hours

    aspiration of arterial blood during needle insertion or local haematoma in ultrasound image

  2. The incidence of pneumothorax

    Time frame: 24 hours

    aspiration of air during needle insertion, or thoracic ultrasonography, or chest radiography

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2018
Registry last updated
Sep 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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