NCT00626899

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

January 14, 2010

Status Verified

January 1, 2010

Enrollment Period

1.1 years

First QC Date

February 20, 2008

Last Update Submit

January 13, 2010

Conditions

Cardiac ArrestHypothermia, Induced

Keywords

Validation of Cardiac Output measurement in hypothermic patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients after cardiac arrest who are treated with therapeutic hypothermia and require a PAC for hemodynamic monitoring

You may qualify if:

  • patients who survived a cardiac arrest and are treated with therapeutic hypothermia
  • pulmonary arterial catheter placed by treating physician

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Intensive Care Medicine - University Hospital Bern - Inselspital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Heart ArrestHypothermia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Matthias Haenggi, MD

    Departement of Intensive Care Medicine, University Hospital Bern, Inselspital, Bern, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 20, 2008

First Posted

February 29, 2008

Study Start

March 1, 2007

Primary Completion

April 1, 2008

Study Completion

May 1, 2008

Last Updated

January 14, 2010

Record last verified: 2010-01

Locations

CH(1)