Viability of Pulsioflex Monitoring in ICU

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04911985

Enrollment

Registered

2021-06-03

Start date

2015-07-01

Completion date

2019-08-30

Last updated

2021-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiogenic Shock

Keywords

Cardiac Output, Cardiac Index, Pulmonary Artery Catheter

Brief summary

Detailed description

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.

Interventions

DEVICEMeasurement of the Cardiac Output/ Cardiac Index

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Percentage Error of CI Measurement	51 Hours	Percentage Error of CI Measurement between Pulsion and PAC measurement

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026