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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Cardiac Surgery
• Intervention / Treatment: Device: Sono with Device; Device: sono only

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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, both the device and sono-guided internal jugular vein catheterization was performed.
PLACEBO_COMPARATOR: 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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 17, 2018
• Primary Completion (ANTICIPATED): November 30, 2018
• Study Completion (ANTICIPATED): December 31, 2018

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: January 3, 2018
• First Posted (ACTUAL): January 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 17, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1-2017-0047

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