Facilitating Needle Alignment With Aiming Method

Central Venous Catheters Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03778437
• Other study ID #: 2018(45)
• Status: Completed
• Phase: N/A
• Start date: February 12, 2019
• Est. completion date: December 27, 2019

Study information

• Verified date: September 2020
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 474
• Est. completion date: December 27, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18 years to 70 years

• American Society of Anesthesiologists (ASA) Physical Status ?-?

• 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

Related Conditions & MeSH terms

• Central Venous Catheters

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Daping Hospital	Chongqing

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural time	the time from skin break to guide wire was positioned into the subclavian vein	24 hours
Primary	Number of skin breaks	number of skin punctures	24 hours
Secondary	The incidence of arterial puncture	aspiration of arterial blood during needle insertion or local haematoma in ultrasound image	24 hours
Secondary	The incidence of pneumothorax	aspiration of air during needle insertion, or thoracic ultrasonography, or chest radiography	24 hours