The Effect of Simple Needle Guide Device for Ultrasound-guided Internal Jugular Vein Catheterization in Cardiac Surgical Patients

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03390543
• Other study ID #: 1-2017-0047
• Status: Withdrawn
• Phase: N/A
• Start date: January 17, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: n/a
• 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 cardiac surgical patients

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. adult ( ?19 years old)

2. patients undergoing elective cardiac surgery

Exclusion Criteria:

1. emergency surgery

2. patients under cervical immobilization

3. anatomical abnormality

4. infection or hematoma at puncture site

5. patients who did not need internal jugular vein catheterization

Related Conditions & MeSH terms

• Cardiac 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, both the device and sono-guided internal jugular vein catheterization was performed.
• sono only
In Group S, simple needle guide device was not attached to the sono probe. After induction of anesthesia, only sono-guided internal jugular vein catheterization was performed.

Locations

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

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 attempts	The number of attempts was counted each time a subject inserted a guide needle into the neck surface, followed by withdrawal, redirection, or reinsertion.	10 minutes after the beginning of the procedure