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CTICU Device Study CRUISE

NCT06828432 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-03-06

No results posted yet for this study

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?

Conditions

  • Open Heart Surgery

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.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Hernando Gomez

    lead OTHER

Principal Investigators

  • Hernando Gomez, MD · University of Pittsburgh

Eligibility

Min Age
18 Years
Max Age
105 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-03
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06828432 on ClinicalTrials.gov