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

Not Applicable

Withdrawn

• Conditions: Cardiac Surgery
• Interventions: Device: Sono with Device; Device: sono only

• Registration Number: NCT03390543
• 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 cardiac surgical patients

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2018-01-03
• Study First Posted: 2018-01-04
• Study Start: 2018-01-17
• Primary Completion: 2018-11-30
• Study Completion: 2018-12-31
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-01-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Device group (Group D)	Sono with Device	Arm Description: Patients in this group are assigned to receive internal jugular vein catheterization guided by ultrasound and simple needle guide device.
sono only group (Group S)	sono only	Patients in this group are assigned to receive internal jugular vein catheterization guided by ultrasound without simple needle guide device.

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
complication rate	24 hours after surgery	incidence of Pneumothorax, Haemothorax, Hydrothorax, carotid artery puncture, Hematoma, Malpositions, puncture of posterior wall of internal jugular vein
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 attempts	10 minutes after the beginning of the procedure	The number of attempts was counted each time a subject inserted a guide needle into the neck surface, followed by withdrawal, redirection, or reinsertion.
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

Trial Locations

Locations (1)

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