CTICU Device Study CRUISE (NCT06828432) | Clinical Trial Compass
By InvitationNot Applicable
CTICU Device Study CRUISE
United States50 participantsStarted 2025-06-03
Plain-language 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?
Who can participate
Age range
18 Years – 105 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.