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

This study has been completed.
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00626899
First received: February 20, 2008
Last updated: January 13, 2010
Last verified: January 2010
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 20, 2008
Last Updated: January 13, 2010
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on July 22, 2014