Ideal Depth of Guide Wire for Central Catheterization

Ideal Depth of Guide Wire for Right Internal Jugular Vein During Central Line Insertion

prospective randomized double-blind controlled study

Study Overview

• Status: Completed
• Conditions: Patient Safety During Central Venous Catheterization
• Intervention / Treatment: Device: central venous catheterization

Detailed Description

Total of 69 ASA (American Society of Anesthesiologist) physical status class I or II patients will be enrolled.

Randomly assigned to three group according to the depth of guide-wire prior to tissue dilation during central catheterization via right internal jugular vein. (Group 1: 15 cm / Group 2: 17.5 cm / Group 3: 20 cm)

Central catheterization will be performed by anesthesiologists who be blinded to this study protocol.

An investigator will monitor and record whether any arrhythmia will occur.

The incidence of occurrence of arrhythmia will be compared between three groups.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Boramae Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients receiving general anesthesia requiring central venous catheterization via right internal jugular vein.
• ASA (American Society of Anesthesiologist) physical status class I or II

Exclusion Criteria:

• at the pre-anesthetic evaluation, history of any arrhythmia
• when monitoring before the induction of anesthesia in the operating room, newly arrhythmia is observed.
• abnormal electrolyte at the pre-anesthetic evaluation
• too difficult to access right internal jugular vein for central catheterization (too short neck, infection at the site of right internal jugular vein, ventriculoperitoneal shunt or chemo-port existence at the site of right internal jugular vein. too close site to operating field)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 15 cm; The depth of guide wire will be 15 cm from puncture site of skin prior to tissue dilation during central venous catheterization	Device: central venous catheterization; 15 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 15 cm. 17.5 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 17.5 cm. 20 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 20 cm.
Experimental: 17.5 cm; The depth of guide wire will be 17.5 cm from puncture site of skin prior to tissue dilation during central venous catheterization	Device: central venous catheterization; 15 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 15 cm. 17.5 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 17.5 cm. 20 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 20 cm.
Active Comparator: 20 cm; The depth of guide wire will be 20 cm from puncture site of skin prior to tissue dilation during central venous catheterization	Device: central venous catheterization; 15 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 15 cm. 17.5 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 17.5 cm. 20 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 20 cm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of arrhythmia	during central venous catheterization

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Director: Jung-Man Lee, M.D., Seoul National University Boramae Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: March 14, 2016
• First Submitted That Met QC Criteria: March 14, 2016
• First Posted (Estimate): March 17, 2016

Study Record Updates

• Last Update Posted (Estimate): July 11, 2016
• Last Update Submitted That Met QC Criteria: July 8, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 16-2015-105