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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03595137
Enrollment
80
Registered
2018-07-23
Start date
2018-07-13
Completion date
2020-12-31
Last updated
2018-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Undergoing Surgery

Brief 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

Interventions

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

1. sono with simple needle guide device group 2. sono only group

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
First access success rateup to 5 minutes after insertion of puncture needleFirst access success rate was defined as the number of sono-guided catheterization obtained within first attempt

Secondary

MeasureTime frameDescription
insertion time10 minutes after the beginning of the proceduredefined as the time in seconds between the beginning of the procedure and guide-wire insertion
complication rate24 hours after surgeryincidence of Pneumothorax, Haemothorax, Hydrothorax, carotid artery puncture, Hematoma, Malpositions, puncture of posterior wall of internal jugular vein
ease of procedure10 minutes after the beginning of the procedureIn 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)
the number of separate skin puncture10 minutes after the beginning of the procedure

Countries

South Korea

Contacts

Primary ContactJin Ha Park Park, MD
realsummer@yuhs.ac82-2-2228-2420

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026