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

Study Overview
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Brief Summary
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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

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

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Device: Sono with Device
* Device: sono only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult ( ≧19 years old) patients undergoing elective cardiac surgery Exclusion Criteria: emergency surgery patients under cervical immobilization anatomical abnormality infection or hematoma at puncture site patients who did not need internal jugular vein catheterization

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: sono with simple needle guide device group sono only group
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device group (Group D)<br>Arm Description: Patients in this group are assigned to receive internal jugular vein catheterization guided by ultrasound and simple needle guide device. | Device: Sono with Device<br>* 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.<br>|
| Placebo Comparator: sono only group (Group S)<br>Patients in this group are assigned to receive internal jugular vein catheterization guided by ultrasound without simple needle guide device. | Device: sono only<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| complication rate | incidence of Pneumothorax, Haemothorax, Hydrothorax, carotid artery puncture, Hematoma, Malpositions, puncture of posterior wall of internal jugular vein | 24 hours after surgery | 
| 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 | 
| 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 |