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

July 12, 2018 updated by: Yonsei University
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Placebo Comparator: sono only group (Group S)
sono only group After induction of anesthesia, sono-guided internal jugular vein cannulation was performed.
Device: Sono only
In group S, sono-guided internal jugular vein cannulation was performed after induction of anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First access success rate
Time Frame: 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
up to 5 minutes after insertion of puncture needle

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
insertion time
Time Frame: 10 minutes after the beginning of the procedure
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
Time Frame: 24 hours after surgery
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
Time Frame: 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)
10 minutes after the beginning of the procedure
the number of separate skin puncture
Time Frame: 10 minutes after the beginning of the procedure
10 minutes after the beginning of the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2018

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

July 12, 2018

First Submitted That Met QC Criteria

July 12, 2018

First Posted (Actual)

July 23, 2018

Study Record Updates

Last Update Posted (Actual)

July 23, 2018

Last Update Submitted That Met QC Criteria

July 12, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 1-2018-0027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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