Open Heart SurgeryCRUISENCT06828432
CTICU Device Study CRUISE
An observational study of Open Heart Surgery, run by Hernando Gomez at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Open Heart Surgery
- What is being tested?
- CRUISE CTICU CareTaker Vitalstream Device, CRUISE CTICU CNAP Device and CRUISE CTICU Edwards Clearsight Device
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2025to 31 Jan 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients (18 years and older)
- Male and female patients following cardiac surgery admitted to the CTICU with or without a pulmonary artery catheter
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Validation of Three Non-invasive Hemodynamic Monitoring Systems for Determining Measures of Volume Responsiveness, Ventriculo-arterial Coupling and Cardiac Output
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.
Read more
The main question the study aims to answer is:
- What monitor is the most accurate in capturing non-invasive patient data?
Read the 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.
- Conditions
- Open Heart Surgery
- Being tested
- CRUISE CTICU CareTaker Vitalstream Device, CRUISE CTICU CNAP Device, CRUISE CTICU Edwards Clearsight Device
- Keywords
- Heart, Surgery, ICU, Monitor, Blood Pressure, Measurement, non-invasive, responsiveness, cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRUISE CTICU CareTaker Vitalstream DeviceDevice
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.
CRUISE CTICU CNAP DeviceDevice
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.
CRUISE CTICU Edwards Clearsight DeviceDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke Volume Variation
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.
Measured: 8 hours
Pulse Pressure Variation (PPV)
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.
Measured: 8 hours
Arterial Dynamic Elastance (Eadyn)
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).
Measured: 8 hours
Secondary outcomes (2)
Cardiac Output
Compare measures of CO by the ClearSight, CareTaker and CNAP 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. 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 to pressure support ventilation, after 30+/-5 minutes of changing ventilatory.
Measured: 8 hours
Volume Responsiveness Collection
The performance of ClearSight, CareTaker and CNAP in predicting volume responsiveness as compared to LiDCO, using a change of 10% or more in CO in response to fluid administration measured with a PAC as the definition of volume responsiveness. 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 to pressure support ventilation, after 30+/-5 minutes of changing ventilatory mode to pressure support ventilation, before extubation (within 5minutes), after extubation .
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start3 Jun 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Open Heart SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hernando Gomez
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, Hernando Gomez, University of Pittsburgh
- Investigators
- Hernando Gomez, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828432
- Sponsor's protocol ID
- STUDY24080125
- Other IDs
- HT9425-24-C-0121
- Acronym
- CRUISE
- Status last verified
- Mar 2026
- First submitted
- 13 Jan 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We will not share any data outside our study team. The DOD requires all vendors to sign NDAs and commit to the rules of the study. Any party that may have access to the data will be part of the study team and committed thru NDAs \& subcontracts.
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.
PubMed 10051276Ramsey 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.
PubMed 10794325
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Three Non-invasive Hemodynamic Monitoring Systems for Determining Measures of Volume Responsiveness, Ventriculo-arterial Coupling and Cardiac Output
- ClinicalTrials.gov ID
- NCT06828432
- Acronym / sponsor ID
- CRUISE / STUDY24080125
- Conditions
- Open Heart Surgery
- Keywords
- Heart, Surgery, ICU, Monitor, Blood Pressure, Measurement, non-invasive, responsiveness, cardiac
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hernando GomezUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adult patients (18 years and older)
- Male and female patients following cardiac surgery admitted to the CTICU with or without a pulmonary artery catheter
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRUISE CTICU CareTaker Vitalstream DeviceThe 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 DeviceThe 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 DeviceThe 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. | Device | – |
Primary outcome
Stroke Volume Variation
Time frame: 8 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)
Time frame: 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)
Time frame: 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).
2 secondary outcomes
Cardiac Output
Time frame: 8 hours
Volume Responsiveness Collection
Time frame: 8 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Background: PubMed 10051276Michard 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.
- Background: PubMed 10794325Ramsey 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.
- Individual participant dataSharing planned: No. We will not share any data outside our study team. The DOD requires all vendors to sign NDAs and commit to the rules of the study. Any party that may have access to the data will be part of the study team and committed thru NDAs \& subcontracts.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hernando Gomez, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Heart Surgery, run by Hernando Gomez at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke Volume Variation (time frame: 8 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06828432, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.