Clinical trial NCT04911985: Viability of Pulsioflex Monitoring in ICU
Official title: Appraisal of the Exactness of a Method to Semiinvasively Evaluate the Cardiac Output of ICU-Patients Through the Use of the Pulsioflex Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiogenic Shock
Keywords: Cardiac Output
Cardiac Index
Pulmonary Artery Catheter
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 42
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Patients admitted to the Medical ICU of the University Hospital Zürich complying with the inclusion and exclusion criteria

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bias of proAQT measurement
timeFrame: 51 Hours
Secondary outcomes:
measure: Percentage Error of CI Measurement
timeFrame: 51 Hours
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Medical intensive care unit
state: ZH
Study officials:
References:
citation: Ameloot K, Van De Vijver K, Broch O, Van Regenmortel N, De Laet I, Schoonheydt K, Dits H, Bein B, Malbrain ML. Nexfin noninvasive continuous hemodynamic monitoring: validation against continuous pulse contour and intermittent transpulmonary thermodilution derived cardiac output in critically ill patients. ScientificWorldJournal. 2013 Nov 11;2013:519080. doi: 10.1155/2013/519080. eCollection 2013.
citation: Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
citation: Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999 Jun;8(2):135-60. doi: 10.1177/096228029900800204.
citation: Broch O, Carbonell J, Ferrando C, Metzner M, Carstens A, Albrecht M, Gruenewald M, Hocker J, Soro M, Steinfath M, Renner J, Bein B. Accuracy of an autocalibrated pulse contour analysis in cardiac surgery patients: a bi-center clinical trial. BMC Anesthesiol. 2015 Nov 26;15:171. doi: 10.1186/s12871-015-0153-2.
citation: Smetkin AA, Hussain A, Kuzkov VV, Bjertnaes LJ, Kirov MY. Validation of cardiac output monitoring based on uncalibrated pulse contour analysis vs transpulmonary thermodilution during off-pump coronary artery bypass grafting. Br J Anaesth. 2014 Jun;112(6):1024-31. doi: 10.1093/bja/aet489. Epub 2014 Feb 13.