Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone

NCT ID: NCT00583687

Last Updated: 2009-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2009-01-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DEVICE

Passive leg raising

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

Intervention Type: 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.

Intervention Type: OTHER

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.

Intervention Type: DEVICE

Other Intervention Names

Vigileo TM / Flotrac TM; Inspectra TM; O-To-See TM

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Departement of Intensive Care Medicine, University Hospital Inselspital, Berne

Principal Investigators

Christoph C Ganter, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Department of Intensive Care Medicine, University Hospital Inselspital, Berne

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

KEK-3107-UHB-1316

Identifier Type: -

Identifier Source: org_study_id