Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone

Conditions
-----------------
Cardiac Output, High, Cardiac Output, Low, Vasodilation, Vasoconstriction, Hemodynamics

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


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Vigileo TM / Flotrac TM (Minimally invasive cardiac output system consisting of arterial line sensor and cardiac output monitor)|Attachment of the arterial line sensor and pulse contour cardiac output monitor to the arterial line of the patient.|
|Other: Passive leg raising|Passive leg raising for prediction of fluid responsiveness with arterial pulse contour analysis.|
|Other: Volume challenge / Change of vasoactive drugs or inotropics|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.|
|Device: Inspectra TM/O-To-See TM (Tissue oxymetry with near infrared spectroscopy and laser-Doppler)|Tissue oxymetry continuously measured with near infrared spectrometry and laser Doppler during the whole study period.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of cardiac output measured by three different techniques during changes of vascular tone |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of fluid responsiveness with minimally invasive arterial pulse contour analysis in hemodynamic unstable patients. |  | 2 hours | 
| Comparison of global parameters of oxygen delivery and consumption with local parameters of flow and tissue oxymetry during changes of vascular tone. |  | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arterial pulse contour cardiac output, Changing vascular tone, Tissue Oxymetry, Prediction of Fluid Responsiveness