Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone

Not Applicable

Completed

• Conditions: Vasoconstriction; Hemodynamics; Cardiac Output, Low; Cardiac Output, High; Vasodilation

• Registration Number: NCT00583687
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-31
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-27
• Last Update Posted: 2009-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes of cardiac output measured by three different techniques during changes of vascular tone	2 hours

Secondary Outcome Measures

Name	Time	Method
Prediction of fluid responsiveness with minimally invasive arterial pulse contour analysis in hemodynamic unstable patients.	2 hours
Comparison of global parameters of oxygen delivery and consumption with local parameters of flow and tissue oxymetry during changes of vascular tone.	2 hours

Trial Locations

Locations (1)

Department of Intensive Care Medicine, University Hospital Inselspital, Berne; 🇨🇭 Bern, Switzerland