Reliability of Central Venous Pressure Measurements (CVP)

May 1, 2017 updated by: University of Oklahoma

Reliability of Central Venous Pressure Measurements From Peripherally Inserted Central Catheters vs. Centrally Inserted Central Catheters

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.

Study Overview

Status

Terminated

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Univeristy of Oklahoma Health Sciences Center Dept. Anesthesiology
      • Oklahoma City, Oklahoma, United States, 73104
        • Univeristy of Oklahoma Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CICC comparison with PICC
All patients will be having CVP reading taken from the CICC
Peripheral inserted catheter placement to take the reading
Other Names:
  • 18-gauge double lumen PICC
Other: 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
Peripheral inserted catheter placement to take the reading
Other Names:
  • 18-gauge double lumen PICC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CICC reading comparison with PICC
Time Frame: 1 year
This might also reduce the complications associated with CICC procedures
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2009

Primary Completion (Actual)

August 27, 2016

Study Completion (Actual)

August 27, 2016

Study Registration Dates

First Submitted

May 3, 2010

First Submitted That Met QC Criteria

May 4, 2010

First Posted (Estimate)

May 5, 2010

Study Record Updates

Last Update Posted (Actual)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 1911

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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