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

Overview

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.

Interventions

• Device CRUISE CTICU CareTaker Vitalstream Device
  The CareTaker Vitalstream device is a patented PDA technology and artificial intelligence algorithms derive continuous hemodynamic parameters by analyzing reflective pulse wave analyzes the pulse pressure waveform at 500 times per second, isolates the individual central aortic pulses that give rise to the observed pulse shape, reads central aortic measurements therefore eliminating the effects of hydrostatic pressure, and tracks vascular tone.
• Device CRUISE CTICU CNAP Device
  The CNAP Monitor provides advanced hemodynamic information from the non-invasive reusable CNAP finger sensor. It supports your Goal Directed Therapy whenever an arterial line is not indicated. Patient-friendly, easy-to-use, cost-efficient. CNAP Monitor offers a unique set of parameters to support your daily routine - all non-invasive \& continuous allowing for perioperative fluid management even in low and moderate-risk surgeries and patients.
• Device CRUISE CTICU Edwards Clearsight Device
  The Edwards ClearSight system provides continuous blood pressure and advanced hemodynamic parameters from a noninvasive finger cuff. Continuous data offered by the ClearSight system enables you to proactively optimize perfusion through hemodynamic management.

Primary outcome measures

• Stroke Volume Variation [Time frame: 8 hours]
• Pulse Pressure Variation (PPV) [Time frame: 8 hours]
• Arterial Dynamic Elastance (Eadyn) [Time frame: 8 hours]

Secondary outcome measures (2)

• Cardiac Output [Time frame: 8 hours]
• Volume Responsiveness Collection [Time frame: 8 hours]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Other

Study locations

United States · 1 center

• University Pittsburgh Medical Center — Pittsburgh

Publications

• 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. PMID 10051276
• 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. PMID 10794325

Identifiers

NCT: NCT06828432 · STUDY24080125 · HT9425-24-C-0121

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗