Ideal Depth of Guide Wire for Central Catheterization

NCT ID: NCT02711761

Last Updated: 2016-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-05-31

Brief Summary

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prospective randomized double-blind controlled study

Detailed Description

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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.

Conditions

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Patient Safety During Central Venous Catheterization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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15 cm

The depth of guide wire will be 15 cm from puncture site of skin prior to tissue dilation during central venous catheterization

Group Type EXPERIMENTAL

central venous catheterization

Intervention Type DEVICE

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.

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

Group Type EXPERIMENTAL

central venous catheterization

Intervention Type DEVICE

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.

20 cm

The depth of guide wire will be 20 cm from puncture site of skin prior to tissue dilation during central venous catheterization

Group Type ACTIVE_COMPARATOR

central venous catheterization

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jung-Man Lee

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jung-Man Lee, M.D.

Role: STUDY_DIRECTOR

Seoul National University Boramae Hospital

Locations

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Seoul National University Boramae Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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16-2015-105

Identifier Type: -

Identifier Source: org_study_id

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