CTICU Device Study CRUISE

Conditions

• Open Heart Surgery

Eligibility Criteria

Sex

ALL

Age

18 Years - 105 Years

Healthy Volunteers

Not accepted

Interventions

• CRUISE CTICU CareTaker Vitalstream Device — 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.
• CRUISE CTICU CNAP Device — 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.
• CRUISE CTICU Edwards Clearsight Device — 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.

Study Details

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?

Key Dates

Start date

Jun 3, 2025

Status verified

Mar 2026

Primary completion

Jan 31, 2027

Completion

Jan 31, 2027

Study Design

Enrollment

50 participants (estimated)

Primary Outcome Measure

Stroke Volume Variation [ Time Frame: 8 hours ]

Locations (1)

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