Clinical trial NCT01995877: Evaluation of the Influence of Body Position on the Inferior Vena Cava (IVC) Diameter
Official title: Evaluation of the Influence of Body Position on the Inferior Vena Cava (IVC) Diameter
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Vena Cava Filters
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Bard Ltd
First posted: 2013-11-27
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are receiving an IVC(inferior vena cava) filter as part of their standard therapy.

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.

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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Primary outcomes:
measure: Body postural changes and the effect on the diameter of the inferior vena cava.
timeFrame: 45 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan Hospital
name: Ranjith Vellody, M.D.
role: PRINCIPAL_INVESTIGATOR
References: