- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01116973
Reliability of Central Venous Pressure Measurements (CVP)
Reliability of Central Venous Pressure Measurements From Peripherally Inserted Central Catheters vs. Centrally Inserted Central Catheters
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
|
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:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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.