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

Yonsei University

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Conditions

Cardiac Surgery

Interventions

Sono with DeviceDEVICE

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 onlyDEVICE

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Seoul, Korea, South Korea

Outcomes

Primary Outcomes

First access success rate

First access success rate was defined as the number of sono-guided catheterization obtained within first attempt.

Time frame: up to 5 minutes after insertion of puncture needle

Secondary Outcomes

insertion time

defined as the time in seconds between the beginning of the procedure and guide-wire insertion

Time frame: 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

Time frame: 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)

Time frame: 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.

Time frame: 10 minutes after the beginning of the procedure

Data from ClinicalTrials.gov

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