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

NCT03390543 | Withdrawn

• 1 other identifier: 1-2017-0047
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 cardiac surgical patients

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• insertion time

  10 minutes after the beginning of the procedure

• complication rate

  24 hours after surgery

• ease of procedure

  10 minutes after the beginning of the procedure

• The number of attempts

  10 minutes after the beginning of the procedure

Study Arms (2)

Device group (Group D)

EXPERIMENTAL

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

sono only group (Group S)

PLACEBO COMPARATOR

Patients in this group are assigned to receive internal jugular vein catheterization guided by ultrasound without simple needle guide device.

Device: sono only

Interventions

Sono with Device 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.

Device group (Group D)

sono only DEVICE

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.

sono only group (Group S)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult ( ≧19 years old)
• patients undergoing elective cardiac surgery

You may not qualify if:

• emergency surgery
• patients under cervical immobilization
• anatomical abnormality
• infection or hematoma at puncture site
• patients who did not need internal jugular vein catheterization

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, Korea, 03722, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: participants, investicator, outcome assessors will be blinded for group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. sono with simple needle guide device group 2. sono only group

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 4, 2018
• Study Start: January 17, 2018
• Primary Completion: November 30, 2018
• Study Completion: December 31, 2018
• Last Updated: January 17, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)