Optimal Insertion Depth of Left Internal Jugular Vein Catheter in Infants

September 12, 2019 updated by: Hee-Soo Kim, Seoul National University Hospital

External Validation of Predictive Formula for Optimal Insertion Depth of Left Internal Jugular Venous Catheter in Infants

We previously performed a study to create formula for the optimal insertion depth of left internal jugular vein catheter in infant, which was registered at cris.nih.go.kr. We found that two calculation methods using height and the distance between landmarks (0.11 × height (cm) + 0.19 and 1.02 × I-A-B (cm) + 1.55, where I was insertion point of needle, A was the most prominent point of the sternal head of the left clavicle, and B was the midpoint of the perpendicular line drawn between the sternal head of the right clavicle and an imaginary line between the nipples) were clinically feasible to determine the insertion depth of left internal jugular vein catheter. In this study, we will compare the actual insertion depth with the insertion depth determined from above two calculation methods in other 46 infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

determine the optimal insertion depth of left internal jugular vein catheter in infants

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • An infant requiring a central venous catheter during surgery

Exclusion Criteria:

  • Extracardiac vascular anomaly
  • Dextrocardia
  • Anatomical abnormality in neck and thorax

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Central venous catheterization
Central venous catheterization will be performed using 4Fr central venous catheter at left internal jugular vein in infant. The tip of central venous catheter will be confirmed by transthoracic echocardiography. The actual insertion depth of central venous catheter will be compared to the predicted insertion depth derived from two calculation methods using height and the distance between the anatomical landmarks.
Procedure: 4Fr central venous catheter insertion
The central venous catheter is placed at left internal jugular vein in infant, and its tip is confirmed by transthoracic echocardiography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The actual insertion depth of central venous catheter
Time Frame: About 5 minutes during central venous catheterization (10 minutes after anesthetic induction)
The actual insertion depth of central venous catheter placed at left internal jugular vein
About 5 minutes during central venous catheterization (10 minutes after anesthetic induction)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The differences between the actual insertion depth and the predicted insertion depth derived from two calculation methods
Time Frame: About 5 minutes during central venous catheterization (10 minutes after anesthetic induction)
The differences between the actual insertion depth and the predicted insertion depth derived from two calculation methods
About 5 minutes during central venous catheterization (10 minutes after anesthetic induction)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2017

Primary Completion (Actual)

March 9, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

January 17, 2017

First Submitted That Met QC Criteria

January 17, 2017

First Posted (Estimate)

January 19, 2017

Study Record Updates

Last Update Posted (Actual)

September 16, 2019

Last Update Submitted That Met QC Criteria

September 12, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • H1701-038-821

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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