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

NCT ID: NCT03595137

Last Updated: 2018-07-23

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-13

Study Completion Date

2020-12-31

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 surgical patients

Detailed Description

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Conditions

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Patients Undergoing 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

Study Groups

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sono with simple needle guide device group (Group D)

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.

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, sono-guided internal jugular vein cannulation was performed.

sono only group (Group S)

sono only group After induction of anesthesia, sono-guided internal jugular vein cannulation was performed.

Group Type PLACEBO_COMPARATOR

Sono only

Intervention Type DEVICE

In group S, sono-guided internal jugular vein cannulation was performed after induction of anesthesia

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, sono-guided internal jugular vein cannulation was performed.

Intervention Type DEVICE

Sono only

In group S, sono-guided internal jugular vein cannulation was performed after induction of anesthesia

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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
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, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jin Ha Park Park, MD

Role: CONTACT

82-2-2228-2420

Facility Contacts

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Jin Ha Park, MD

Role: primary

82-2-2228-2420

Other Identifiers

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1-2018-0027

Identifier Type: -

Identifier Source: org_study_id

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