Facilitating Needle Alignment With Aiming Method

NCT ID: NCT03778437

Last Updated: 2020-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 474 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-12
• Study Completion Date: 2019-12-27

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

landmark techniques

Intervention Type: 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 with aiming method

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

Group Type: EXPERIMENTAL

subclavian vein catheterization

Intervention Type: 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 plus needle guide techniques

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

Group Type: EXPERIMENTAL

Ultrasound-guided plus needle guide techniques

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Qingxiang Mao

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Daping Hospital

Chongqing, , China

Countries

China

Other Identifiers

2018(45)

Identifier Type: -

Identifier Source: org_study_id