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NCT00626899 Clinical Trial

Comparison Performance Vigileo vs. Continuous CCO (Vigilance) in Patients With Induced Therapeutic Hypothermia

Cardiac Arrest Clinical Trial

Official title:
Comparison of the Performance of a New Pulse-contour Analysis Cardiac Output Measurement (Vigileo) With the Traditional Method in Patients With Induced Therapeutic Hypothermia After Cardiac Arrest

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00626899
Other study ID # KIM-Vig/Vig
Secondary ID
Status Completed
Phase N/A
First received February 20, 2008
Last updated January 13, 2010
Start date March 2007
Est. completion date May 2008

Study information
Verified date January 2010
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial Summary

Patients resuscitated from a cardiac arrest undergo therapeutic hypothermia as a treatment option. Measuring the cardiac output in these patients is sometimes important, but difficult, as these patients require an invasive device for measurement. Recently, a non-invasive device based on pulse-contour analysis of the arterial pulse was developed (the Vigileo). Hypothermia changes the pulse contour, so the performance of the Vigileo in patients with induced therapeutic hypothermia is not known. Therefore we conduct this observational study in which the cardiac output of the patients is measured with the traditional method and the Vigileo simultaneously.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date May 2008
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients who survived a cardiac arrest and are treated with therapeutic hypothermia

- pulmonary arterial catheter placed by treating physician

Exclusion Criteria:

- arterial catheter placement is contraindicated

- Aortic valve insufficiency (moderate to severe)

- placement of intra-aortic balloon pump (IABP) or a LVAD (left ventricular assist device)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland Departement of Intensive Care Medicine - University Hospital Bern - Inselspital Bern

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

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