Viability of Pulsioflex Monitoring in ICU

Completed

• Conditions: Cardiogenic Shock
• Interventions: Device: Measurement of the Cardiac Output/ Cardiac Index

• Registration Number: NCT04911985
• Lead Sponsor: University of Zurich

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-07-01
• Study First Submitted: 2018-09-17
• Primary Completion: 2019-02-01
• Study Completion: 2019-08-30
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-02
• Study First Posted: 2021-06-03
• Last Update Submitted: 2021-06-03
• Last Update Posted: 2021-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU Patients with PAC	Measurement of the Cardiac Output/ Cardiac Index	All patients admitted to the Medical ICU of the University Hospital Zürich, complying with the inclusion criteria and monitored by a pilmonary artery catheter

Primary Outcome Measures

Name	Time	Method
Bias of proAQT measurement	51 Hours	Bias between the Pulsion CI measurement and the gold standard CI measurement by Pulmonary artery catheterisation

Secondary Outcome Measures

Name	Time	Method
Percentage Error of CI Measurement	51 Hours	Percentage Error of CI Measurement between Pulsion and PAC measurement

Trial Locations

Locations (1)

University Hospital Zurich, Medical intensive care unit; 🇨🇭 Zurich, ZH, Switzerland