Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone

This study has been completed.
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00583687
First received: December 18, 2007
Last updated: April 27, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention
Cardiac Output, High
Cardiac Output, Low
Vasodilation
Vasoconstriction
Hemodynamics
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
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Changes of cardiac output measured by three different techniques during changes of vascular tone [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prediction of fluid responsiveness with minimally invasive arterial pulse contour analysis in hemodynamic unstable patients. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: December 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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 Name: Vigileo TM / Flotrac TM
    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.
    Other Names:
    • Inspectra TM
    • O-To-See TM
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583687

Locations
Switzerland
Department of Intensive Care Medicine, University Hospital Inselspital, Berne
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Edwards Lifesciences
Investigators
Principal Investigator: Christoph C Ganter, M.D. Department of Intensive Care Medicine, University Hospital, Inselspital, Berne
  More Information

No publications provided

Responsible Party: Christoph C Ganter, MD, Departement of Intensive Care Medicine, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT00583687     History of Changes
Other Study ID Numbers: KEK-3107-UHB-1316
Study First Received: December 18, 2007
Last Updated: April 27, 2009
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
Arterial pulse contour cardiac output
Changing vascular tone
Tissue Oxymetry
Prediction of Fluid Responsiveness

Additional relevant MeSH terms:
Cardiac Output, Low
Cardiac Output, High
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 16, 2014