Ideal Depth of Guide Wire for Central Catheterization

Patient Safety During Central Venous Catheterization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02711761
• Other study ID #: 16-2015-105
• Status: Completed
• Phase: N/A
• First received: March 14, 2016
• Last updated: July 8, 2016
• Start date: September 2015
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

prospective randomized double-blind controlled study

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: May 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Patient Safety During Central Venous Catheterization

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Boramae Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of arrhythmia		during central venous catheterization	Yes