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Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Completed
CT.gov ID
NCT00583687
Collaborator
Edwards Lifesciences (Industry)
30
Enrollment
1
Location
13
Duration (Months)
2.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone
Study Start Date :
Dec 1, 2007
Actual Primary Completion Date :
Jan 1, 2009
Actual Study Completion Date :
Jan 1, 2009

Outcome Measures

Primary Outcome Measures

  1. Changes of cardiac output measured by three different techniques during changes of vascular tone [2 hours]

Secondary Outcome Measures

  1. Prediction of fluid responsiveness with minimally invasive arterial pulse contour analysis in hemodynamic unstable patients. [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. [2 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00583687
Other Study ID Numbers:
  • KEK-3107-UHB-1316
First Posted:
Dec 31, 2007
Last Update Posted:
Apr 28, 2009
Last Verified:
Apr 1, 2009
Keywords provided by , ,
Arterial pulse contour cardiac output
Changing vascular tone
Tissue Oxymetry
Prediction of Fluid Responsiveness
Additional relevant MeSH terms:
Cardiac Output, Low
Cardiac Output, High

Study Results

No Results Posted as of Apr 28, 2009