Facilitating Needle Alignment With Aiming Method

NCT03778437 | Completed

• 1 other identifier: 2018(45)
• Study Type: interventional
• Target: 474
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Central Venous Catheters

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• The incidence of arterial puncture

  24 hours

• The incidence of pneumothorax

  24 hours

Study Arms (3)

landmark techniques

ACTIVE COMPARATOR

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

ultrasound-guided with aiming method

EXPERIMENTAL

Subclavian vein catheterization is performed with our newly proposed aiming method with the guidance of ultrasound.

Procedure: subclavian vein catheterization

ultrasound-guided plus needle guide techniques

EXPERIMENTAL

Subclavian vein catheterization is performed under ultrasound guidance with in-plane technique.

Procedure: Ultrasound-guided plus needle guide techniques

Interventions

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.

ultrasound-guided with aiming method

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.

landmark techniques

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.

ultrasound-guided plus needle guide techniques

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Daping Hospital

Chongqing, 400042, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 19, 2018
• Study Start: February 12, 2019
• Primary Completion: December 20, 2019
• Study Completion: December 27, 2019
• Last Updated: September 23, 2020

Record last verified: 2020-09

Locations

CN (1)