Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone - Full Text View

Sponsors and Collaborators:	University Hospital Inselspital, Berne Edwards Lifesciences
Information provided by:	University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:	NCT00583687

Purpose

The purpose of this study is to compare changes of minimally invasive arterial pulse contour cardiac output with changes of intermittent and continuous thermodilution cardiac output by pulmonary artery catheter in hemodynamic unstable patients with rapid changing vascular tone (changing dosage of vasoactive drugs or inotropics, or volume challenge). Simultaneously, global parameters of oxygen delivery and consumption will be compared with regional flow parameters and tissue oxymetry (near infrared spectrometry and laser-Doppler). While continuous thermodilution cardiac output is used for patient management, pulse contour cardiac output, intermittent thermodilution cardiac output and tissue oxymetry is only used for monitoring.

Condition	Intervention
Cardiac Output, High Cardiac Output, Low Hemodynamics Vasoconstriction Vasodilation	Device: Vigileo TM / Flotrac TM (Minimally invasive cardiac output system consisting of arterial line sensor and cardiac output monitor) Device: Inspectra TM/O-To-See TM (Tissue oxymetry with near infrared spectroscopy and laser-Doppler) Other: Passive leg raising Other: Volume challenge / Change of vasoactive drugs or inotropics

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Single Group Assignment, Treatment
Official Title:	Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone

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

Primary Outcome Measures:

Changes of cardiac output measured by three different techniques during changes of vascular tone [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Prediction of fluid responsiveness with minimally invasive arterial pulse contour analysis in hemodynamic unstable patients. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Comparison of global parameters of oxygen delivery and consumption with local parameters of flow and tissue oxymetry during changes of vascular tone. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Attachment of the arterial line sensor and pulse contour cardiac output monitor to the arterial line of the patient.

Tissue oxymetry continuously measured with near infrared spectrometry and laser Doppler during the whole study period.

Passive leg raising for prediction of fluid responsiveness with arterial pulse contour analysis.

Either a volume challenge (using colloids or crystalloids) or a change in the dosage of of vasoactive drugs or inotropics, or a combination of them, as proposed by the treating physician.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Indication for invasive hemodynamic monitoring with pulmonary artery catheter and arterial catheter
Hemodynamic instability (need for vasoactive drugs, inotropics or volume).

Exclusion Criteria:

Age < 18.
Patient with contraindications for the placement of arterial cannula.
Patient with history or clinical findings of aortic valve regurgitation.
Atrial fibrillation.
Patient being treated with an intra-aortic balloon pump.
Limitation of therapy due to bad prognosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583687

Contacts

Contact: Christoph C Ganter, M.D.

0041-31-632 01 67

christoph.ganter@insel.ch

Locations

Switzerland
Department of Intensive Care Medicine, University Hospital Inselspital, Berne	Recruiting
Bern, Switzerland, 3010
Contact: Christoph C Ganter, M.D. 0041-31-632 01 67 christoph.ganter@insel.ch
Principal Investigator: Christoph C Ganter, M.D.

Sponsors and Collaborators

University Hospital Inselspital, Berne

Edwards Lifesciences

Investigators

Principal Investigator:

Christoph C Ganter, M.D.

Department of Intensive Care Medicine, University Hospital, Inselspital, Berne

More Information

No publications provided

Responsible Party:	Departement of Intensive Care Medicine, University Hospital Inselspital, Berne ( Christoph C Ganter, MD )
Study ID Numbers:	KEK-3107-UHB-1316
Study First Received:	December 18, 2007
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00583687 History of Changes
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:

Arterial pulse contour cardiac output
Changing vascular tone
Prediction of Fluid Responsiveness
Tissue Oxymetry

Study placed in the following topic categories:

Signs and Symptoms
Heart Diseases
Cardiac Output, High
Cardiac Output, Low

Additional relevant MeSH terms:

Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Cardiac Output, High
Cardiac Output, Low

ClinicalTrials.gov processed this record on March 16, 2009