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Clinical Trials/NCT01079611
NCT01079611CompletedNot Applicable

Non-invasive Assessments of Central Venous Pressure by Ultrasound and Clinical Examination: a Prospective Comparative Study

University Hospital, Basel, Switzerland1 site in 1 country81 target enrollmentStarted: May 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
81
Locations
1

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients age greater than 18 years are study candidates if they need central venous access and invasive hemodynamic monitoring, according to the discretion of the treating physician.
  • Informed consent is given.

Exclusion Criteria

  • Patients are ineligible if they have a history of neck or body radiotherapy and/or previous or active upper-extremity deep venous thrombosis.
  • Informed consent is not given.

Investigators

Sponsor
University Hospital, Basel, Switzerland
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Heiko Uthoff

Principal Investigator

University Hospital, Basel, Switzerland

Study Sites (1)

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