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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00626899
First Posted: February 29, 2008
Last Update Posted: January 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Inselspital, Berne
  Purpose
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.

Condition
Cardiac Arrest Hypothermia, Induced

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Enrollment: 8
Study Start Date: March 2007
Study Completion Date: May 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients after cardiac arrest who are treated with therapeutic hypothermia and require a PAC for hemodynamic monitoring
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626899


Locations
Switzerland
Departement of Intensive Care Medicine - University Hospital Bern - Inselspital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Matthias Haenggi, MD Departement of Intensive Care Medicine, University Hospital Bern, Inselspital, Bern, Switzerland
  More Information

Responsible Party: Matthias Haenggi, Department of Intensive Care Medicine, University Hospital Bern - Inselspital
ClinicalTrials.gov Identifier: NCT00626899     History of Changes
Other Study ID Numbers: KIM-Vig/Vig
First Submitted: February 20, 2008
First Posted: February 29, 2008
Last Update Posted: January 14, 2010
Last Verified: January 2010

Keywords provided by University Hospital Inselspital, Berne:
Validation of Cardiac Output measurement in hypothermic patients

Additional relevant MeSH terms:
Heart Arrest
Hypothermia
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms