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Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone

Primary Purpose

Cardiac Output, High, Cardiac Output, Low, Vasodilation

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Vigileo TM / Flotrac TM (Minimally invasive cardiac output system consisting of arterial line sensor and cardiac output monitor)
Passive leg raising
Volume challenge / Change of vasoactive drugs or inotropics
Inspectra TM/O-To-See TM (Tissue oxymetry with near infrared spectroscopy and laser-Doppler)
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Output, High focused on measuring Arterial pulse contour cardiac output, Changing vascular tone, Tissue Oxymetry, Prediction of Fluid Responsiveness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Intensive Care Medicine, University Hospital Inselspital, Berne

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Prediction of fluid responsiveness with minimally invasive arterial pulse contour analysis in hemodynamic unstable patients.
Comparison of global parameters of oxygen delivery and consumption with local parameters of flow and tissue oxymetry during changes of vascular tone.

Full Information

First Posted
December 18, 2007
Last Updated
April 27, 2009
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT00583687
Brief Title
Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone
Official Title
Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Edwards Lifesciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Output, High, Cardiac Output, Low, Vasodilation, Vasoconstriction, Hemodynamics
Keywords
Arterial pulse contour cardiac output, Changing vascular tone, Tissue Oxymetry, Prediction of Fluid Responsiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Vigileo TM / Flotrac TM (Minimally invasive cardiac output system consisting of arterial line sensor and cardiac output monitor)
Other Intervention Name(s)
Vigileo TM / Flotrac TM
Intervention Description
Attachment of the arterial line sensor and pulse contour cardiac output monitor to the arterial line of the patient.
Intervention Type
Other
Intervention Name(s)
Passive leg raising
Intervention Description
Passive leg raising for prediction of fluid responsiveness with arterial pulse contour analysis.
Intervention Type
Other
Intervention Name(s)
Volume challenge / Change of vasoactive drugs or inotropics
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Inspectra TM/O-To-See TM (Tissue oxymetry with near infrared spectroscopy and laser-Doppler)
Other Intervention Name(s)
Inspectra TM, O-To-See TM
Intervention Description
Tissue oxymetry continuously measured with near infrared spectrometry and laser Doppler during the whole study period.
Primary Outcome Measure Information:
Title
Changes of cardiac output measured by three different techniques during changes of vascular tone
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Prediction of fluid responsiveness with minimally invasive arterial pulse contour analysis in hemodynamic unstable patients.
Time Frame
2 hours
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph C Ganter, M.D.
Organizational Affiliation
Department of Intensive Care Medicine, University Hospital, Inselspital, Berne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Intensive Care Medicine, University Hospital Inselspital, Berne
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

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Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone

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