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

Terminated

• Conditions: Vena Cava Filters
• Interventions: Procedure: Subjects scheduled for IVC filter placement

• Registration Number: NCT01995877
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-27
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects scheduled for IVC filter placement	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.

Primary Outcome Measures

Name	Time	Method
Body postural changes and the effect on the diameter of the inferior vena cava.	45 minutes	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.

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States