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

NCT ID: NCT03390543

Last Updated: 2019-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-17

Study Completion Date

2018-12-31

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

Detailed Description

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Conditions

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Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1. sono with simple needle guide device group
2. sono only group
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
participants, investicator, outcome assessors will be blinded for group allocation.

Study Groups

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Device group (Group D)

Arm Description: Patients in this group are assigned to receive internal jugular vein catheterization guided by ultrasound and simple needle guide device.

Group Type EXPERIMENTAL

Sono with Device

Intervention Type 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 group (Group S)

Patients in this group are assigned to receive internal jugular vein catheterization guided by ultrasound without simple needle guide device.

Group Type PLACEBO_COMPARATOR

sono only

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, Korea, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1-2017-0047

Identifier Type: -

Identifier Source: org_study_id

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