Viability of Pulsioflex Monitoring in ICU

Study Overview
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Brief Summary
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Goal of the Study is to Study the precision of semi-invasive cardiac index monitoring by means of the ProAQT (PULSION Medical Systems SE) sensor, whereby the pulmonary artery catheter will serve as gold standard.

Detailed Description
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Goal of the Study is to Study the precision of semi-invasive cardiac index monitoring by means of the ProAQT (PULSION Medical Systems SE) sensor, whereby the pulmonary artery catheter will serve as gold standard. Measurements will be performed contemporaly with both devices every 4 hours and all clinical and hemodynmaic parameters will be recorded, including but not limited to central venous pressure, wege pressure, mechanical ventilation pressures, blood pressures, volume balance as well as vasoaktive medikation doses. This precise evaluation shall serve to evaluate the precision of the ProAQT to estimate the cardiac index under different clinical situation in the intensive care unit. A precision difference of below 30% between both methods will be regarded as clinically irrelevant, suggesting equipoise between both methods.

Official Title
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Appraisal of the Exactness of a Method to Semiinvasively Evaluate the Cardiac Output of ICU-Patients Through the Use of the Pulsioflex Device

Conditions
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Cardiogenic Shock

Intervention / Treatment
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* Device: Measurement of the Cardiac Output/ Cardiac Index


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In situ pulmonary artery catheter Above 16 years of age At least 36 hours of continuous hemodynamic monitoring with the pulmonary artery catheter planed Exclusion Criteria: Patients with: Permanent or pesisting Atrial Fibrilation or Ventricular Arrythmias Moderate to Severe Aortic Insuficiency or Aortic Stenosis Intravascular Cardiac Assist Device Planed removal of the pulmonary artery catheter <36 hours

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICU Patients with PAC<br>All patients admitted to the Medical ICU of the University Hospital Zürich, complying with the inclusion criteria and monitored by a pilmonary artery catheter | Device: Measurement of the Cardiac Output/ Cardiac Index<br>* Semiinvasive Measurement of the Cardiac Output/ Cardiac Index with the Pulsion device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bias of proAQT measurement | Bias between the Pulsion CI measurement and the gold standard CI measurement by Pulmonary artery catheterisation | 51 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Error of CI Measurement | Percentage Error of CI Measurement between Pulsion and PAC measurement | 51 Hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Output, Cardiac Index, Pulmonary Artery Catheter