Accuracy of CVC Depth Prediction in Internal Jugular Veins: The Difference Between The Andropoulos and ECG Methods

August 18, 2020 updated by: Aida Rosita Tantri, Indonesia University
compare the accuracy of CVC depth prediction in internal jugular veins: the difference between the andropoulos and ECG methods

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

seventy two subjects were given informed consent before the study started. compare the accuracy of CVC depth prediction in internal jugular veins with two difference methods, the andropoulos method and ECG method.

Study Type

Interventional

Enrollment (Actual)

72

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

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 10430
        • Cipto Mangunkusumo Cental National Hospital

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • signing informed consent form
  • indicated for CVC insertion
  • has no contraindication for right internal jugular vein CVC insertion

Exclusion Criteria:

  • has history of arrhythmia
  • has cardiac malformation history

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: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Andropulous method

Andropulous method uses equations to determine the depth of CVC insertion.

For subject with <100 cm in height:

Depth of CVC insertion (cm) = (height (cm)/ 10)-1

For subject with >100 cm in height:

Depth of CVC insertion (cm) = (height (cm)/ 10)-2
Other: andropulous method
Counts the CVC depth using specific equation
ACTIVE_COMPARATOR: ECG method
change in p wave from ECG
Device: ECG
Using ECG to monitor the insertion of the CVC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CVC prediction depth using andropulous equation
Time Frame: 30 minutes
CVC will be inserted in certain depth according to the calculated depth
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ECG change
Time Frame: 30 seconds
changes in p wave during CVC insertion
30 seconds

Collaborators and Investigators

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

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Aida R Tantri, Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 12, 2019

Primary Completion (ACTUAL)

June 12, 2020

Study Completion (ACTUAL)

June 12, 2020

Study Registration Dates

First Submitted

December 30, 2019

First Submitted That Met QC Criteria

December 30, 2019

First Posted (ACTUAL)

January 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 20, 2020

Last Update Submitted That Met QC Criteria

August 18, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • IndonesiaUAnes 042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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