The Effect of Simple Needle Guide Device for Ultrasound-guided Internal Jugular Vein Catheterization in Surgical Patients: a Randomized-controlled Trial

Patients Undergoing Surgery Clinical Trial

Official title:

The Effect of Simple Needle Guide Device for Ultrasound-guided Internal Jugular Vein Catheterization in Surgical Patients: a Randomized-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03595137
• Other study ID #: 1-2018-0027
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2018
• Source: Yonsei University
• Contact: Jin Ha Park Park, MD
• Phone: 82-2-2228-2420
• Email: realsummer[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of simple needle guide device for ultrasound-guided internal jugular vein catheterization in surgical patients

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2020
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. adult ( ?19 years old)

2. patients undergoing elective surgery

Exclusion Criteria:

1. emergency surgery

2. patients under cervical immobilization

3. anatomical abnormality for Right internal jugular vein catheterization

4. infection or hematoma at puncture site

5. patients who did not need internal jugular vein catheterization

Related Conditions & MeSH terms

• Patients Undergoing Surgery

Intervention

Device:
• Sono with Device
In Group D, simple needle guide device was attached to the sono probe. Device was designed to assist the detection of the puncture site. After induction of anesthesia, sono-guided internal jugular vein cannulation was performed.
• Sono only
In group S, sono-guided internal jugular vein cannulation was performed after induction of anesthesia

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First access success rate	First access success rate was defined as the number of sono-guided catheterization obtained within first attempt	up to 5 minutes after insertion of puncture needle
Secondary	insertion time	defined as the time in seconds between the beginning of the procedure and guide-wire insertion	10 minutes after the beginning of the procedure
Secondary	complication rate	incidence of Pneumothorax, Haemothorax, Hydrothorax, carotid artery puncture, Hematoma, Malpositions, puncture of posterior wall of internal jugular vein	24 hours after surgery
Secondary	ease of procedure	In order to measure the degree of difficulty felt by the subjects during the procedure, a 100mm visual analogue scale was used to measure 10 difficulty levels (100mm; ease, 0mm ; difficult)	10 minutes after the beginning of the procedure
Secondary	the number of separate skin puncture		10 minutes after the beginning of the procedure