NCT02711761

Brief Summary

prospective randomized double-blind controlled study

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

6 months

First QC Date

March 14, 2016

Last Update Submit

July 8, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of arrhythmia

    during central venous catheterization

Study Arms (3)

15 cm

EXPERIMENTAL

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

17.5 cm

EXPERIMENTAL

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

20 cm

ACTIVE COMPARATOR

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

Interventions

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.

15 cm17.5 cm20 cm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Boramae Hospital

Seoul, Seoul, South Korea

Location

MeSH Terms

Interventions

Catheterization, Central Venous

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Officials

  • Jung-Man Lee, M.D.

    Seoul National University Boramae Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 14, 2016

First Posted

March 17, 2016

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

May 1, 2016

Last Updated

July 11, 2016

Record last verified: 2016-07

Locations