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

Not Applicable

• Conditions: Patients Undergoing Surgery
• Interventions: Device: Sono with Device; Device: Sono only

• Registration Number: NCT03595137
• Lead Sponsor: Yonsei University

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-07-12
• Study First Submitted QC: 2018-07-12
• Last Update Submitted: 2018-07-12
• Study Start: 2018-07-13
• Study First Posted: 2018-07-23
• Last Update Posted: 2018-07-23
• Primary Completion: 2019-07-01
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. adult ( ≧19 years old)
2. patients undergoing elective surgery

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sono with simple needle guide device group (Group D)	Sono with Device	sono with simple needle guide device 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 group (Group S)	Sono only	sono only group After induction of anesthesia, sono-guided internal jugular vein cannulation was performed.

Primary Outcome Measures

Name	Time	Method
First access success rate	up to 5 minutes after insertion of puncture needle	First access success rate was defined as the number of sono-guided catheterization obtained within first attempt

Secondary Outcome Measures

Name	Time	Method
insertion time	10 minutes after the beginning of the procedure	defined as the time in seconds between the beginning of the procedure and guide-wire insertion
ease of procedure	10 minutes after the beginning of the 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)
the number of separate skin puncture	10 minutes after the beginning of the procedure
complication rate	24 hours after surgery	incidence of Pneumothorax, Haemothorax, Hydrothorax, carotid artery puncture, Hematoma, Malpositions, puncture of posterior wall of internal jugular vein

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of