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

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ClinicalTrials.gov Identifier: NCT03535038
Recruitment Status : Completed
First Posted : May 24, 2018
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Amir S Madjid, Indonesia University

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

Condition or disease Intervention/treatment Phase
Unintubated Patients in ICU and Resuscitation Room Diagnostic Test: Inferior vena cava (IVC) diameter using USG Diagnostic Test: Vascular pedicle width (VPW) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Agreement Test of Intravascular Volume Assessment Between Inferior Vena Cava (IVC) Diameter and Vascular Pedicle Width (VPW)
Actual Study Start Date : May 31, 2018
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays

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.




Primary Outcome Measures :
  1. Intravascular volume measurement [ Time Frame: IVC is measured 30 minutes after VPW ]
    Measured by VPW and IVC diameter using USG



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03535038


Locations
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Indonesia
Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University

Publications:

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Responsible Party: Amir S Madjid, Anesthesiologist, Indonesia University
ClinicalTrials.gov Identifier: NCT03535038     History of Changes
Other Study ID Numbers: IndonesiaUAnes023
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amir S Madjid, Indonesia University:
Intravascular volume
Inferior vena cava diameter
Ultrasonography
Vascular Pedicle Width
Chest x-ray