Viability of Pulsioflex Monitoring in ICU

University of Zurich (UZH)

Status: Completed

Conditions: Cardiogenic Shock

Treatments: Device: Measurement of the Cardiac Output/ Cardiac Index

Study type: Observational

Funder types: Other

Identifiers

NCT04911985

proAQT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 16+ years old

Volunteers: No 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

Trial design

42 participants in 1 patient group

ICU Patients with PAC

Description:

All patients admitted to the Medical ICU of the University Hospital Zürich, complying with the inclusion criteria and monitored by a pilmonary artery catheter

Treatment:

Device: Measurement of the Cardiac Output/ Cardiac Index