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NCT06828432

CTICU Device Study CRUISE

Enrolling by Invitation
Not specifiedAges 18+Observational
Hernando Gomez
~50 participants
Updated 2026-03-06 on ClinicalTrials.gov
What's tested:CRUISE CTICU CareTaker Vitalstream DeviceCRUISE CTICU CNAP DeviceCRUISE CTICU Edwards Clearsight Device

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Stroke Volume Variation
Measured over 8 hours
+2 more outcomes measured

Conditions

Open Heart Surgery

Explore related trials

Heart Disorder

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Hernando Gomez, MD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Stroke Volume Variation8 hours

    The Stroke Volume Variation (SSV) will be collected continuously for 8 hours using all 3 devices (ClearSight, CareTaker and CNAP). The metric of performance will be the precision, accuracy and concordance assessed using Bland Altman analysis and Pearson's moment analysis comparing SVV from each of the non-invasive monitors with the reference standard obtained from the analysis of the arterial pressure waveform. Measurement of SVV, PPV, Eadyn and CO from non-invasive monitors will be obtained continuously, but the quantity will be recorded at different timepoints including: Baseline, every 30 min after baseline, before each bolus of crystalloid fluid or blood product (within 5 minutes of administration, after each bolus of crystalloid fluid or blood product (within 5 minutes of stopping), before each change in vasopressors or inotropes (within 5 minutes of administration), after each change in vasopressors or inotropes (within 5 minutes of stopping), before changing ventilatory mode.

  • Pulse Pressure Variation (PPV)8 hours

    The Pulse Pressure Variation will be collected continuously for 8 hours using all 3 devices (ClearSight, CareTaker and CNAP). The metric of performance will be the precision, accuracy and concordance assessed using Bland Altman analysis and Pearson's moment analysis comparing PPV from each of the non-invasive monitors with the reference standard obtained from the analysis of the arterial pressure waveform. This metric of performance will be reported. The most reliable device will be based on the metric of performance - that is, the most precise, accurate and concordant. Measurement of SVV, PPV, Eadyn and CO from non-invasive monitors will be obtained continuously, but the quantity will be recorded at different timepoints including: Baseline, every 30 min after baseline, before each bolus of crystalloid fluid or blood product (within 5 minutes of administration, after each bolus of crystalloid fluid or blood product (within 5 minutes of stopping), before each change in vasopressors.

  • Arterial Dynamic Elastance (Eadyn)8 hours

    The Arterial Dynamic Elastance (Eadyn) will be collected continuously for 8 hours using all 3 devices (ClearSight, CareTaker and CNAP). The metric of performance will be the precision, accuracy and concordance assessed using Bland Altman analysis and Pearson's moment analysis comparing Eadyn from each of the non-invasive monitors with the reference standard obtained from the analysis of the arterial pressure waveform. This metric of performance will be reported. The most reliable device will be based on the metric of performance - that is, the most precise, accurate and concordant. Measurement of SVV, PPV, Eadyn and CO from non-invasive monitors will be obtained continuously, but the quantity will be recorded at different timepoints including: Baseline, every 30 min after baseline, before each bolus of crystalloid fluid or blood product (within 5 minutes of administration, after each bolus of crystalloid fluid or blood product (within 5 minutes of stopping).