NCT03025178

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

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

First Submitted

Initial submission to the registry

January 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 8, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2018

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

September 16, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

January 17, 2017

Last Update Submit

September 12, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • The actual insertion depth of central venous catheter

    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 Outcomes (1)

  • 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)

Study Arms (1)

Central venous catheterization

EXPERIMENTAL

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

Interventions

The central venous catheter is placed at left internal jugular vein in infant, and its tip is confirmed by transthoracic echocardiography.

Central venous catheterization

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • An infant requiring a central venous catheter during surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SNUH

Seoul, Jongro Gu, 15710, South Korea

Location

Study Officials

  • Hee-Soo Kim, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 17, 2017

First Posted

January 19, 2017

Study Start

March 8, 2017

Primary Completion

March 9, 2018

Study Completion

April 1, 2018

Last Updated

September 16, 2019

Record last verified: 2019-09

Locations