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

University of Michigan

Status: Terminated

Conditions: Vena Cava Filters

Treatments: Procedure: Subjects scheduled for IVC filter placement

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01995877

HUM00034464

Details and patient eligibility

About

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

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

2 participants in 1 patient group

Subjects scheduled for IVC filter placement

Description:

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.

Treatment:

Procedure: Subjects scheduled for IVC filter placement