CClinicalTrials.gg
Status unknownNCT03595137Updated Jul 23, 2018

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

An interventional study of Sono with Device and Sono only in Patients Undergoing Surgery, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2018-07-23.

Sponsored by Yonsei University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Patients Undergoing Surgery
03

In context

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceSono 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.

  • DeviceSono only

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

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. the number of separate skin puncture

    Time frame: 10 minutes after the beginning of the procedure

07

Study locations

1 of 1 sites recruiting
  • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
    Seoul, 03722, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03595137
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Jul 23, 2018
Start date
Jul 13, 2018
Primary completion
Jul 1, 2019 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Jul 23, 2018

Study contacts

Jin Ha Park Park, MD
Contact
realsummer@yuhs.ac
82-2-2228-2420

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion