Reliability of Central Venous Pressure Measurements

NCT01116973 | Terminated

• 1 other identifier: 1911
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

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.

Conditions

Hemodynamics; Central Venous Pressure

Keywords

CVP monitoring compared with peripheral monitoring

Outcome Measures

Primary Outcomes (1)

• Central venous pressure comparison with peripheral venous pressure

  We will compare the realiablity of reading collected via central venous pressure reading and compare it with peripheral venous pressure reading.

  1 year

Secondary Outcomes (1)

• CICC reading comparison with PICC

  1 year

Study Arms (2)

CICC comparison with PICC

OTHER

All patients will be having CVP reading taken from the CICC

Other: PICC

PICC group

OTHER

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

Interventions

PICC OTHER

Peripheral inserted catheter placement to take the reading

Also known as: 18-gauge double lumen PICC

CICC comparison with PICC; PICC group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (2)

Univeristy of Oklahoma Health Sciences Center Dept. Anesthesiology

Oklahoma City, Oklahoma, 73104, United States

Location

Univeristy of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Study Officials

• Pamela Roberts, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 5, 2010
• Study Start: September 2, 2009
• Primary Completion: August 27, 2016
• Study Completion: August 27, 2016
• Last Updated: May 4, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)