Cardiac ArrestNCT00626899
Comparison Performance Vigileo vs. Continuous CCO (Vigilance) in Patients With Induced Therapeutic Hypothermia
An observational study of Cardiac Arrest and Hypothermia, Induced, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Hypothermia, Induced
- How many people
- 8 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2007to May 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after cardiac arrest who are treated with therapeutic hypothermia and require a PAC for hemodynamic monitoring
Who may be able to join
- patients who survived a cardiac arrest and are treated with therapeutic hypothermia
- pulmonary arterial catheter placed by treating physician
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Departement of Intensive Care Medicine - University Hospital Bern - Inselspital
Bern, 3010
About this study
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
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.
- Conditions
- Cardiac Arrest, Hypothermia, Induced
- Keywords
- Validation of Cardiac Output measurement in hypothermic patients
- Medical subject headings
- Heart Arrest, Hypothermia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startMar 2007
- Primary completionApr 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Matthias Haenggi, MD, Principal investigator, Departement of Intensive Care Medicine, University Hospital Bern, Inselspital, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626899
- Sponsor's protocol ID
- KIM-Vig/Vig
- Status last verified
- Jan 2010
- First submitted
- 20 Feb 2008
- Last updated
- 14 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00626899
- Acronym / sponsor ID
- KIM-Vig/Vig
- Conditions
- Cardiac Arrest, Hypothermia, Induced
- Keywords
- Validation of Cardiac Output measurement in hypothermic patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 29 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after cardiac arrest who are treated with therapeutic hypothermia and require a PAC for hemodynamic monitoring
Key inclusion criteria (2 listed)
- patients who survived a cardiac arrest and are treated with therapeutic hypothermia
- pulmonary arterial catheter placed by treating physician
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Haenggi, MD principal investigator
Departement of Intensive Care Medicine, University Hospital Bern, Inselspital, Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest and Hypothermia, Induced, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2010.