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OpenTrials
Completed

NCT Number: NCT04911985

Viability of Pulsioflex Monitoring in ICU

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.

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Key information

Conditions

Cardiogenic Shock Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich, Medical intensive care unit

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measurement of the Cardiac Output/ Cardiac Index

Device

Semiinvasive Measurement of the Cardiac Output/ Cardiac Index with the Pulsion device

Primary outcomes

  1. Bias of proAQT measurement

    Time frame: 51 Hours

    Bias between the Pulsion CI measurement and the gold standard CI measurement by Pulmonary artery catheterisation

Secondary outcomes

  1. Percentage Error of CI Measurement

    Time frame: 51 Hours

    Percentage Error of CI Measurement between Pulsion and PAC measurement

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jun 3, 2021
Registry last updated
Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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