Clinical trial NCT06828432: CTICU Device Study CRUISE
Official title: Validation of Three Non-invasive Hemodynamic Monitoring Systems for Determining Measures of Volume Responsiveness, Ventriculo-arterial Coupling and Cardiac Output
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Open Heart Surgery
Keywords: Heart, Surgery, ICU, Monitor, Blood Pressure, Measurement
non-invasive
responsiveness
cardiac
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2025-02-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with estimates of cardiac output (CO) in patients with an indwelling pulmonary artery catheter. in 50 intensive care unit, intubated patients during the patient's normal course of treatment using their usually present invasive monitoring devices for the first 8 hours following cardiac surgery.

Brief summary: The goal of this study evaluate three novel, Food and Drug Administration (FDA)-approved devices currently used to monitor blood pressure and the amount of blood that the heart pumps during each beat.

These devices are the ClearSight (Edwards Life Sciences), CareTaker (CareTaker Medical) and CNAP (CNS Systems). These devices measure blood pressure, how much blood the heart is pumping around the body each minute and on a heartbeat to heartbeat basis and other parameters that can tell the doctor if the patient will benefit from specific treatments. The purpose of this study is to determine the accuracy of these devices. This knowledge will help us understand how investigators can use such non-invasive devices to care for patients at less risk than the devices currently used for such purposes.

The main question the study aims to answer is:

• What monitor is the most accurate in capturing non-invasive patient data?

Detailed description: Investigators will compare predictors of preload responsiveness, including pulse pressure variation (PPV) and stroke volume variation (SVV), and arterial dynamic elastance (Eadyn) in all patients and estimates of cardiac output (CO) in patients with an indwelling pulmonary artery catheter. in 50 intensive care unit, intubated patients during the patient's normal course of treatment using their usually present invasive monitoring devices for the first 8 hours following cardiac surgery.

The primary goal of the study will be to compare PPV, SVV and Eadyn measured by the non-invasive monitors ClearSight, CareTaker and CNAP versus a reference standard that uses invasive arterial pressure waveform data, which in this case will be the LiDCO monitor \& FloTrac monitor. Investigators will calculate accuracy, precision and concordance of each of the parameters measured during steady state conditions and after specific interventions including the administration of crystalloid fluid boluses and changes in vasoactive or inotropic medications. As a secondary objective, investigators will compare measures of CO by the same non-invasive monitors with the pulmonary artery catheter as a reference standard during the same conditions as above (i.e., steady state conditions, and before/after interventions). CO will therefore be only compared in patients that have a pulmonary artery catheter in place.

Eligibility criteria: Inclusion Criteria:

* Adult patients (18 years and older)
* Male and female patients following cardiac surgery admitted to the CTICU with or without a pulmonary artery catheter

Exclusion Criteria:

* Subjects whose sternum remains open post-surgery and/or the presence of a LV ventricular assist device.
* Presence of a any ventricular assist device, ECMO, Impella, durable LVAD, or central L/RVAD.
* Spontaneous breathing activity upon coming out of the operating room (i.e., patients extubated in the operating room).
* Presenting chronic atrial fibrillation, refractory acute atrial fibrillation to medical therapy or frequent extra-systoles.
* Children will be excluded from this study. The hospital unit where all subjects will be recruited is for adults' (ages 18 and up) only. Gender, racial and ethnic sub groups will not be explicitly excluded.

Primary outcomes:
measure: Stroke Volume Variation
timeFrame: 8 hours
measure: Pulse Pressure Variation (PPV)
timeFrame: 8 hours
measure: Arterial Dynamic Elastance (Eadyn)
timeFrame: 8 hours
Secondary outcomes:
measure: Cardiac Output
timeFrame: 8 hours
measure: Volume Responsiveness Collection
timeFrame: 8 hours
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Hernando Gomez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Michard F, Chemla D, Richard C, Wysocki M, Pinsky MR, Lecarpentier Y, Teboul JL. Clinical use of respiratory changes in arterial pulse pressure to monitor the hemodynamic effects of PEEP. Am J Respir Crit Care Med. 1999 Mar;159(3):935-9. doi: 10.1164/ajrccm.159.3.9805077.
citation: Ramsey SD, Saint S, Sullivan SD, Dey L, Kelley K, Bowdle A. Clinical and economic effects of pulmonary artery catheterization in nonemergent coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2000 Apr;14(2):113-8. doi: 10.1016/s1053-0770(00)90001-6.