Evaluation of the Influence of Body Position on the Inferior Vena Cava (IVC) Diameter

NCT01995877 | Terminated DMC

• 1 other identifier: HUM00034464
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if laying down or standing up changes the diameter of the inferior vena cava.

Conditions

Vena Cava Filters

Outcome Measures

Primary Outcomes (1)

• Body postural changes and the effect on the diameter of the inferior vena cava.

  Migration of IVC filters is not frequent; however it is a serious complication, which may be caused by changes in the diameter of the IVC related to changes in the position of the body and/or increased pressure in the abdomen. The purpose of this study is to evaluate how much postural changes of the body affect the diameter of the IVC.

  45 minutes

Study Arms (1)

Subjects scheduled for IVC filter placement

A filter may be needed to be placed in the IVC (inferior vena cava) to prevent blood clots from traveling from legs to lungs. Patients who have had a pelvic fracture, or have blood clots in the leg(s) may need an IVC. Filter placement may be ordered when a patient is scheduled for major surgery and extensive bed rest.

Procedure: Subjects scheduled for IVC filter placement

Interventions

Subjects scheduled for IVC filter placement PROCEDURE

Subjects will have an intra vascular ultrasound (IVUS) performed while lying down on the exam table; this will be performed before and after the IVC (inferior vena cava) filter is placed. During the ultrasound, measurements of the diameter of different areas of the IVC will be taken. The table will then be moved so that you are in a standing position and the measurements will be taken again. The ultrasound will be done by the physician performing your procedure. When you are lying down, a sheath (small catheter) will be inserted into a vein in your groin. The IVUS (intra vascular ultrasound) catheter will be inserted through the sheath and used to measure the size of the IVC at various places. The IVUS procedure will add about 30-45 minutes to the filter placement procedure.

Also known as: IVUS(intra vascular ultrasound)

Subjects scheduled for IVC filter placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who are receiving an IVC(inferior vena cava) filter as part of their standard therapy.

You may qualify if:

• years of age and older
• Subjects who will have a clinically indicated IVC filter placement procedure scheduled.
• Only subjects with no contraindications to being elevated up to a standing or near standing position on the angiography table.

You may not qualify if:

• Pregnant
• Have a broken leg or any other physical condition that won't allow you to stand.
• If you are in a traction device
• If you have a brain injury and require special monitoring of the pressure in the brain.
• Patients on a ventilator cannot participate in this study.

Sponsors & Collaborators

• University of Michigan: lead
• Bard Ltd: collaborator

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• Ranjith Vellody, M.D.

  University of Michigan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: November 27, 2013
• Study Start: October 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 4, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)