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

• Sponsor: Indonesia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03535038
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 2
• Actual Duration (Months): 6
• Patients Per Site Per Month: 5.8

Study Details

Study Description

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)	N/A

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 Design

• Study Type: Interventional
• 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: Jul 31, 2018
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Intravascular volume measurement [IVC is measured 30 minutes after VPW]

   Measured by VPW and IVC diameter using USG

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cipto Mangunkusumo Cental National Hospital	Jakarta	DKI Jakarta	Indonesia	10430

Sponsors and Collaborators

• Indonesia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Responsible Party: Amir S Madjid, Anesthesiologist, Indonesia University
• ClinicalTrials.gov Identifier: NCT03535038
• Other Study ID Numbers: IndonesiaUAnes023
• First Posted: May 24, 2018
• Last Update Posted: Jan 17, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Amir S Madjid, Anesthesiologist, Indonesia University: Intravascular volume; Inferior vena cava diameter; Ultrasonography; Vascular Pedicle Width; Chest x-ray

Study Results

No Results Posted as of Jan 17, 2019