Reliability of Central Venous Pressure Measurements

NCT ID: NCT01116973

Last Updated: 2017-05-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-02
• Study Completion Date: 2016-08-27

Brief Summary

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.

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.

Conditions

Hemodynamics; Central Venous Pressure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CICC comparison with PICC

All patients will be having CVP reading taken from the CICC

Group Type: OTHER

PICC

Intervention Type: OTHER

Peripheral inserted catheter placement to take the reading

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

Group Type: OTHER

PICC

Intervention Type: OTHER

Peripheral inserted catheter placement to take the reading

Interventions

PICC

Peripheral inserted catheter placement to take the reading

Intervention Type: OTHER

Other Intervention Names

18-gauge double lumen PICC

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pamela Roberts, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

Univeristy of Oklahoma Health Sciences Center Dept. Anesthesiology

Oklahoma City, Oklahoma, United States

Univeristy of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

1911

Identifier Type: -

Identifier Source: org_study_id