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Completed

NCT Number: NCT00583687

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.

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Key information

Conditions

Cardiac Output, High Aneurysm Cardiac Output, Low Cardiovascular Diseases Heart Diseases Hemodynamics Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases Vasoconstriction Vasodilation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Intensive Care Medicine, University Hospital Inselspital, Berne

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vigileo TM / Flotrac TM (Minimally invasive cardiac output system consisting of arterial line sensor and cardiac output monitor)

Device

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

Other names: Vigileo TM / Flotrac TM

Passive Leg Raising

Other

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

Volume challenge / Change of vasoactive drugs or inotropics

Other

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.

Inspectra TM/O-To-See TM (Tissue oxymetry with near infrared spectroscopy and laser-Doppler)

Device

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

Other names: Inspectra TM, O-To-See TM

Primary outcomes

  1. Changes of cardiac output measured by three different techniques during changes of vascular tone

    Time frame: 2 hours

Secondary outcomes

  1. Prediction of fluid responsiveness with minimally invasive arterial pulse contour analysis in hemodynamic unstable patients.

    Time frame: 2 hours

  2. 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

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Edwards Lifesciences

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 31, 2007
Registry last updated
Apr 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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