Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00583687

Enrollment

Registered

2007-12-31

Start date

2007-12-31

Completion date

2009-01-31

Last updated

2009-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

DEVICEVigileo 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.

OTHERPassive leg raising

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

OTHERVolume 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.

DEVICEInspectra 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026