Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone

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.

Conditions

• Cardiac Output, High
• Cardiac Output, Low
• Vasodilation
• Vasoconstriction
• Hemodynamics

Interventions

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.

Sponsors & Collaborators

• Edwards Lifesciences

  collaborator INDUSTRY

• Insel Gruppe AG, University Hospital Bern

  lead OTHER

Principal Investigators

• Christoph C Ganter, M.D. · Department of Intensive Care Medicine, University Hospital, Inselspital, Berne

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-12-31

Primary Completion

2009-01-31

Completion

2009-01-31

Countries

• Switzerland

Study Locations