Measurement of Intravascular Volume Using USG of IVC Diameter Compared to VPW Chest X-ray

January 15, 2019 updated by: Amir S Madjid, Indonesia University

Agreement Test of Intravascular Volume Assessment Between Inferior Vena Cava (IVC) Diameter and Vascular Pedicle Width (VPW)

This study aimed to know the consistency of intravascular volume measurement using USG of IVC compared to VPW chest x-ray

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Validation and reliability test were done for USG operators by assessing IVC in 20 patients supervised by intensivists. Subjects were given informed consent before participating in the study. Subjects underwent the chest x-ray examination with supine position. The measurement of VPW was done by radiologists, considered normal if the value is 53 ± 5 mm, overload if VPW > 71 mm. The subjects then underwent the IVC diameter measurement using USG Philips En Visor C, with transthoracal subcostal approach. The result is considered normal if IVC diameter is 1.5 - 2.5 cm and overload if >2.5 cm, otherwise the subjects is excluded. If the IVC can not be done, subjects will be excluded.

Study Type

Interventional

Enrollment (Actual)

35

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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult non-intubated patients aged 18-65 in ICU or resucitation room
  • BMI 18.5-35 kg/m2
  • Signed informed consent of the patient to be included in the study

Exclusion Criteria:

  • BMI >35, intubated
  • History of thoracic or heart surgery
  • History of external and internal radiation
  • Pregnant

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: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Inferior vena cava (IVC) diameter
subjects underwent IVC diameter measurement after VPW measurement
Diagnostic test: Inferior vena cava (IVC) diameter using USG
IVC diameter is measured from the distal of right hepatic pain and inferior vena cava meeting point using Philips En Visor C USG.
ACTIVE_COMPARATOR: Vascular pedicle width (VPW)
Supine chest x ray was done and the VPW is assessed by radiologists.
Diagnostic test: Vascular pedicle width (VPW)
VPW is measured by drawing a line from the left subclavian artery exit point from aorta perpendicular to the point where superior vena cava crosses with right bronchi.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intravascular volume measurement
Time Frame: IVC is measured 30 minutes after VPW
Measured by VPW and IVC diameter using USG
IVC is measured 30 minutes after VPW

Collaborators and Investigators

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

Sponsor

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)

May 31, 2018

Primary Completion (ACTUAL)

July 31, 2018

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

May 12, 2018

First Submitted That Met QC Criteria

May 12, 2018

First Posted (ACTUAL)

May 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 17, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IndonesiaUAnes023

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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