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Reliability of Central Venous Pressure Measurements (CVP)

This study has been terminated.
(Change in guidelines by the manufacturer.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01116973
First Posted: May 5, 2010
Last Update Posted: May 4, 2017
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.
Information provided by (Responsible Party):
University of Oklahoma
  Purpose
The purpose of this study is to compare CVP measurements from CICCs and PICCs. The investigators will also evaluate whether or not the duration of CICC placement affects the differences in CVP measurements between the CICCs and PICCs. The investigators hypothesize that the differences between the CVP measurements of the CICCs and PICCs will be clinically insignificant.

Condition Intervention
Hemodynamics Central Venous Pressure Other: PICC

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Reliability of Central Venous Pressure Measurements From Peripherally Inserted Central Catheters vs. Centrally Inserted Central Catheters

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Central venous pressure comparison with peripheral venous pressure [ Time Frame: 1 year ]
    We will compare the realiablity of reading collected via central venous pressure reading and compare it with peripheral venous pressure reading.


Secondary Outcome Measures:
  • CICC reading comparison with PICC [ Time Frame: 1 year ]
    This might also reduce the complications associated with CICC procedures


Enrollment: 17
Actual Study Start Date: September 2, 2009
Study Completion Date: August 27, 2016
Primary Completion Date: August 27, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CICC comparison with PICC
All patients will be having CVP reading taken from the CICC
Other: PICC
Peripheral inserted catheter placement to take the reading
Other Name: 18-gauge double lumen PICC
PICC group
The transition to the PICC, a 5.0-French, 18-gauge double lumen PICC (BARD, Power PICC Solo Catheter with Tip Location Stylet; Salt Lake City, UT) will be inserted
Other: PICC
Peripheral inserted catheter placement to take the reading
Other Name: 18-gauge double lumen PICC

Detailed Description:

Centrally inserted central catheters (CICC) are commonly used in the intensive care unit (ICU) for delivery of fluids, medications, and nutrition. They are also used to measure central venous pressure (CVP) which provides critical information about blood volume status and cardiac function of a patient. Currently, CICCs are the gold standard for measuring CVP, but they have a number of associated risks including pneumothorax, major hemorrhage, neck hematoma, and carotid puncture. An alternative to a CICC is a peripherally inserted central catheter (PICC). A PICC can be placed with lower risks than a CICC, has a lower rate of bloodstream infections, and provides longer-term IV access at a lower cost. PICCs can be used to deliver fluids, medications, and nutrition. However, there is minimal evidence that a PICC can measure CVP as effectively as a CICC. Therefore, a CICC is preferred when a patient requires CVP monitoring in our ICU. Our aim is to compare CVP measurements from CICCs and PICCs. We will also evaluate whether or not the duration of CICC placement affects the differences in CVP measurements between the CICCs and PICCs. We hypothesize that the differences between the CVP measurements of the CICCs and PICCs will be clinically insignificant.

The goal of this study is to determine if the central venous pressure (CVP) measurements obtained from a peripherally inserted central catheter (PICC) consistently correlate with the CVP measurements obtained from a centrally inserted central catheter (CICC). If the difference between the CVP measurements from the CICC and PICC are found to be clinically insignificant, then it may be practical to place PICCs in favor of CICCs thereby avoiding some of the potential complications associated with CICC placement. We also aim to evaluate whether or not the duration of CICC placement affects the differences in CVP measurements between the CICCs and PICCs. We hypothesize that the differences between the CVP measurements of the CICCs and PICCs will be clinically insignificant.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject's ability to lay in a supine position with their hands at their sides during CVP measurements
  • A consent form signed by the patient or patient's representative
  • Subjects that are age 18-90
  • Subjects that have an indwelling CICC and are transitioning to a PICC for long-term IV access
  • CICC placed in the internal jugular vein or subclavian vein position

Exclusion Criteria:

  • Inability to obtain consent
  • Subjects under 18 years of age
  • Non-English speaking subjects
  • Subjects that are unable to lay flat due to pulmonary complications, increased intracranial pressure (ICP), or unstable spinal cord injuries
  • Subjects with known cardiac abnormalities (atrial septal defects or ventricular septal defects, severe tricuspid valve disease, severe pulmonary hypertension, Ejection fraction < 15%)
  • Prisoners
  • Subjects with known upper extremity deep vein thromboses (subclavian or distal)
  • Subjects with non-functional CICC or PICC distal ports
  • Subjects with femoral CICCs
  • Pregnant women
  Contacts and Locations
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): NCT01116973


Locations
United States, Oklahoma
Univeristy of Oklahoma Health Sciences Center Dept. Anesthesiology
Oklahoma City, Oklahoma, United States, 73104
Univeristy of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Pamela Roberts, MD University of Oklahoma
  More Information

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01116973     History of Changes
Other Study ID Numbers: 1911
First Submitted: May 3, 2010
First Posted: May 5, 2010
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Oklahoma:
CVP monitoring compared with peripheral monitoring