Reliability of Central Venous Pressure Measurements (CVP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Oklahoma.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01116973
First received: May 3, 2010
Last updated: February 1, 2012
Last verified: February 2012
  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: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    This might also reduce the complications associated with CICC procedures


Estimated Enrollment: 65
Study Start Date: August 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (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
Comparison of CICC with reading from PICC
Interventional procedure
Either central venous catheter placement to measure CVP or Peripheral placement of catheter.
Other: PICC
Peripheral inserted catheter placement to take the reading
Other Name: The 7.0-French, 16-gauge distal exit port , a 5.0-French, 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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116973

Contacts
Contact: Pamela Roberts, MD 405-271-4351 pamela-roberts@ouhsc.edu
Contact: Qaiser S Khan, MD,MPH 405-271-8001 ext 36016 qaiser-khan@ouhsc.edu

Locations
United States, Oklahoma
Univeristy of Oklahoma Health Sciences Center Dept. Anesthesiology Recruiting
Oklahoma, Oklahoma, United States, 73104
Contact: Pamela Roberts, MD    405-271-4351    Pamela-roberts@ouhsc.edu   
Contact: Qaiser S Khan, MD,MPH    405-271-8001 ext 36016    qaiser-khan@ouhsc.edu   
Principal Investigator: Pamela Roberts, MD         
Univeristy of Oklahoma Health Sciences Center Recruiting
Oklahoma, Oklahoma, United States, 73104
Contact: Pamela Roberts, MD         
Principal Investigator: Pamela Robetrs, MD         
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Pamela Roberts, MD University of Oklahoma
  More Information

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01116973     History of Changes
Other Study ID Numbers: 14813
Study First Received: May 3, 2010
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014