Viability of Pulsioflex Monitoring in ICU

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-01

Study Completion Date

2019-08-30

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.

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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.

Conditions

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Cardiogenic Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ICU Patients with PAC

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

Measurement of the Cardiac Output/ Cardiac Index

Intervention Type DEVICE

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

Interventions

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Measurement of the Cardiac Output/ Cardiac Index

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

Intervention Type DEVICE

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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No