COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01995877
Recruitment Status : Terminated (Poor recruitment, PI leaving university)
First Posted : November 27, 2013
Last Update Posted : May 4, 2017
Sponsor:
Collaborator:
Bard Ltd
Information provided by (Responsible Party):
Ranjith Vellody, University of Michigan

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To determine if laying down or standing up changes the diameter of the inferior vena cava.

Condition or disease Intervention/treatment
Vena Cava Filters Procedure: Subjects scheduled for IVC filter placement

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Influence of Body Position on the Inferior Vena Cava (IVC) Diameter
Study Start Date : October 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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.
 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.

Other Name: IVUS(intra vascular ultrasound)


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Body postural changes and the effect on the diameter of the inferior vena cava. [ Time Frame: 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.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who are receiving an IVC(inferior vena cava) filter as part of their standard therapy.
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.

    -

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.

    -

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995877


Locations
Layout table for location information
United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Bard Ltd
Investigators
Layout table for investigator information
Principal Investigator: Ranjith Vellody, M.D. University of Michigan Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ranjith Vellody, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01995877    
Other Study ID Numbers: HUM00034464
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No