Viability of Pulsioflex Monitoring in ICU

Cardiogenic Shock Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04911985
• Other study ID #: proAQT
• Status: Completed
• Start date: July 1, 2015
• Est. completion date: August 30, 2019

Study information

• Verified date: June 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 30, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock, Cardiogenic

Intervention

Device:
• Measurement of the Cardiac Output/ Cardiac Index
Semiinvasive Measurement of the Cardiac Output/ Cardiac Index with the Pulsion device

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Medical intensive care unit	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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. — View Citation

Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999 Jun;8(2):135-60. Review. — View Citation

Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10. — View Citation

Broch O, Carbonell J, Ferrando C, Metzner M, Carstens A, Albrecht M, Gruenewald M, Höcker 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. — View Citation

Smetkin AA, Hussain A, Kuzkov VV, Bjertnæs 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bias of proAQT measurement	Bias between the Pulsion CI measurement and the gold standard CI measurement by Pulmonary artery catheterisation	51 Hours
Secondary	Percentage Error of CI Measurement	Percentage Error of CI Measurement between Pulsion and PAC measurement	51 Hours