Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone

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.

Study Overview

• Status: Completed
• Conditions: Vasodilation; Vasoconstriction; Hemodynamics; Cardiac Output, Low; Cardiac Output, High
• 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)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Department of Intensive Care Medicine, University Hospital Inselspital, Berne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: Edwards Lifesciences
• Investigators: Principal Investigator: Christoph C Ganter, M.D., Department of Intensive Care Medicine, University Hospital, Inselspital, Berne

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (ACTUAL): January 1, 2009
• Study Completion (ACTUAL): January 1, 2009

Study Registration Dates

• First Submitted: December 18, 2007
• First Submitted That Met QC Criteria: December 20, 2007
• First Posted (ESTIMATE): December 31, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): April 28, 2009
• Last Update Submitted That Met QC Criteria: April 27, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: Arterial pulse contour cardiac output; Changing vascular tone; Tissue Oxymetry; Prediction of Fluid Responsiveness
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiac Output, Low; Cardiac Output, High
• Other Study ID Numbers: KEK-3107-UHB-1316