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

NCT ID: NCT01995877

Last Updated: 2017-05-04

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 2 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-04-30

Brief Summary

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

Detailed Description

Patients are referred for IVC(inferior vena cava)filter placement secondary to trauma, surgery, a fractured pelvis or known blood clots in the lower extremities. The filter is placed to prevent blood clots from traveling into the lungs. The filters are placed during a interventional radiology procedure. During the procedure the diameter of the IVC(inferior vena cava)is measured with the patient in a horizontal position (laying down). The blood pressure in the IVC when a patient is in this position is relatively low in normal circumstances, but may increase substantially when the patient is vertical with secondary dilation of the IVC(inferior vena cava).

Migration of IVC(inferior vena cava)filters is not frequent; however it is a serious complication, which may be caused by changes in the diameter of the IVC(inferior vena cava)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(inferior vena cava).

For research purposes patients will have an intravascular ultrasound (IVUS) performed to measure the IVC diameter before and after a Valsalva maneuver (having the subject hold their breath and bear down as if they were having a bowel movement). The angiographic table will be elevated and the measurements will be repeated.

Conditions

Vena Cava Filters

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Subjects scheduled for IVC filter placement

Intervention Type: 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.

Interventions

Subjects scheduled for IVC filter placement

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.

Intervention Type: PROCEDURE

Other Intervention Names

IVUS(intra vascular ultrasound)

Eligibility Criteria

Inclusion Criteria

1. 18 years of age and older

2. Subjects who will have a clinically indicated IVC filter placement procedure scheduled.

3. Only subjects with no contraindications to being elevated up to a standing or near standing position on the angiography table.

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Exclusion Criteria

1. Pregnant

2. Have a broken leg or any other physical condition that won't allow you to stand.

3. If you are in a traction device

4. If you have a brain injury and require special monitoring of the pressure in the brain.

5. Patients on a ventilator cannot participate in this study.

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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bard Ltd

INDUSTRY

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Ranjith Vellody

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ranjith Vellody, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Hospital

Locations

University of Michigan Hospital

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00034464

Identifier Type: -

Identifier Source: org_study_id