Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone

Hemodynamics Clinical Trial

Official title:

Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00583687
• Other study ID #: KEK-3107-UHB-1316
• Status: Completed
• Phase: N/A
• First received: December 18, 2007
• Last updated: April 27, 2009
• Start date: December 2007
• Est. completion date: January 2009

Study information

• Verified date: April 2009
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Switzerland	Department of Intensive Care Medicine, University Hospital Inselspital, Berne	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Edwards Lifesciences

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of cardiac output measured by three different techniques during changes of vascular tone		2 hours	No
Secondary	Prediction of fluid responsiveness with minimally invasive arterial pulse contour analysis in hemodynamic unstable patients.		2 hours	No
Secondary	Comparison of global parameters of oxygen delivery and consumption with local parameters of flow and tissue oxymetry during changes of vascular tone.		2 hours	No