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Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone

I

Insel Gruppe AG, University Hospital Bern

Status

Completed

Conditions

Vasodilation
Vasoconstriction
Cardiac Output, Low
Cardiac Output, High
Hemodynamics

Treatments

Device: Inspectra TM/O-To-See TM (Tissue oxymetry with near infrared spectroscopy and laser-Doppler)
Device: Vigileo TM / Flotrac TM (Minimally invasive cardiac output system consisting of arterial line sensor and cardiac output monitor)
Other: Volume challenge / Change of vasoactive drugs or inotropics
Other: Passive leg raising

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00583687
KEK-3107-UHB-1316

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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