Non-invasive Assessments of Central Venous Pressure
|ClinicalTrials.gov Identifier: NCT01079611|
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : June 20, 2012
Background: Estimates of central venous pressure (CVP) can be very helpful in guiding fluid therapy in the intensive care unit, operating room or emergency room. Current standard technique for CVP assessment is invasive, requiring insertion of a catheter into a subclavian, internal jugular or peripheral vein. Several ultrasound based and clinical methods have been described as potential non-invasive alternatives to assess CVP.
Aim: To prospectively evaluate the accuracy of CVP assessment by a) inferior vena cava diameter and collapsibility b) internal jugular vein diameter c) compression sonography of a forearm vein and d) clinical assessment of peripheral vein collapse in comparison to invasive CVP measurement.
Study design: single center, prospective observational study
Patients and Methods:
We will examine 77 consecutive patients with invasive venous access and invasive hemodynamic monitoring at the surgical intensive care unit (ICU). After obtaining informed consent, ultrasound examinations of the inferior vena cava, internal jugular vein and compression sonography of a forearm vein as well as clinical evaluation of peripheral vein collapsibility will be performed in a random sequence by different experienced examiner. Invasive CVP is recorded simultaneously to each measurement. Examiners are blinded to clinical parameters and results of previous CVP measurements.
Primary endpoint: Accuracy of each non-invasive method to determine CVP defined by invasively measured CVP.
Secondary endpoint: Comparison of the feasibility of each non-invasive method.
Expected results: We hypothesize that sonographic measurement of inferior vena cava diameter, internal jugular vein diameter and compression sonography of a forearm vein as well as clinical assessment of peripheral vein collapsibility are reliable methods for CVP determination in comparison to invasive CVP measurement.
Significance: The validation and comparison of sonographic / clinic CVP assessment would enable clinicians to choose an accurate non-invasive method to assess volume status which is an important adjunct in the management of many critically ill patients. The non-invasiveness of these methods broadens the feasibility to measure CVP and may guide fluid therapy in new patient populations.
|Condition or disease|
|Venous Pressure, Central Ultrasonic Diagnosis|
|Study Type :||Observational|
|Actual Enrollment :||81 participants|
|Official Title:||Non-invasive Assessments of Central Venous Pressure by Ultrasound and Clinical Examination: a Prospective Comparative Study|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||November 2011|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01079611
|University Hospital Basel|
|Basel, Switzerland, 4031|
|Principal Investigator:||Heiko Uthoff, M.D.||University Hospital Basel, Angiology|
|Principal Investigator:||Kurt A Jaeger, M.D.||University Hospital Basel, Angiology|