Viability of Pulsioflex Monitoring in ICU

• Sponsor: University of Zurich (Other)
• Overall Status: Completed
• CT.gov ID: NCT04911985
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Actual Duration (Months): 50
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiogenic Shock	Device: Measurement of the Cardiac Output/ Cardiac Index

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 Design

• Study Type: Observational
• Actual Enrollment: 42 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Feb 1, 2019
• Actual Study Completion Date: Aug 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
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	Device: Measurement of the Cardiac Output/ Cardiac Index; Semiinvasive Measurement of the Cardiac Output/ Cardiac Index with the Pulsion device

Outcome Measures

Primary Outcome Measures

1. 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

1. Percentage Error of CI Measurement [51 Hours]

   Percentage Error of CI Measurement between Pulsion and PAC measurement

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich, Medical intensive care unit	Zurich	ZH	Switzerland	8091

Sponsors and Collaborators

• University of Zurich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999 Jun;8(2):135-60. Review.
• Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
• 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.
• 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.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT04911985
• Other Study ID Numbers: proAQT
• First Posted: Jun 3, 2021
• Last Update Posted: Jun 8, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by University of Zurich: Cardiac Output; Cardiac Index; Pulmonary Artery Catheter
• Additional relevant MeSH terms: Shock, Cardiogenic

Study Results

No Results Posted as of Jun 8, 2021