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

Vena Cava Filters Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01995877
• Other study ID #: HUM00034464
• Status: Terminated
• Phase: N/A
• First received: November 21, 2013
• Last updated: May 1, 2017
• Start date: October 2010
• Est. completion date: April 2012

Study information

• Verified date: May 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vena Cava Filters

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Bard Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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