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Completed

NCT Number: NCT05905536

Perioperative Monitoring of Cardiac Surgery Patients With the Vitalstream Physiological Monitor

The purpose of this study is to validate cardiac output and stroke volume derived from Vitalstream against Gold Standard measurements obtained using thermodilution. The Vitalstream device is a continuous noninvasive physiological monitor (Caretaker Medical LLC, Charlottesville, Virginia, further referred to as "CTM") provides heart rate, continuous noninvasive blood pressure (BP), respiratory rate, stroke volume and cardiac output.

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Key information

Conditions

Cardiac Output, Low Cardiovascular Diseases Heart Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Volume

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

About this study

The device is currently undergoing IEC 60601 Medical Safety Standards testing and has already passed all FDA-required emission and discharge testing. The Vitalstream tracks central aortic BP via pulse analysis, specifically Pulse Decomposition Analysis ("PDA"), of the peripheral pulse at a distal site, typically finger. The device uses a low pressure [30-40 mmHg], pump-inflated, finger cuff that pneumatically couples arterial pulsations via a pressure line to a custom-designed piezo-electric pressure sensor for detection and analysis. Physiological data are communicated wirelessly to a tablet-based user interface via Bluetooth. The Vitalstream monitor is most beneficial as it is non-invasive, is a minimal risk device, and for this protocol will not be utilized to make treatment decisions for the study subject.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult post-cardiac surgery needing cardiopulmonary bypass and use of the pulmonary artery catheter (PAC) as standard of care, (s/p coronary artery bypass graft (CABG), valve, heart transplant, major aortic & other vascular surgery, and a combination of CABG and valve procedures)
  • patients (age > 18) admitted to the Intensive Care Unit (ICU) with a pulmonary artery catheter (continuous or intermittent thermodilution cardiac output) and an arterial catheter for Blood Pressure (BP) monitoring (standard of care)

Exclusion criteria

  • Patients without an appropriately positioned or functioning (PAC) pulmonary artery catheter admitted to the cardiac surgery ICU after surgery. Patients on left ventricular assist device (LVAD) support

Treatment and study plan

Vitalstream

Device

The device will be placed on the subject and monitoring started in the holding room on the morning of surgery. Monitoring will continue postoperatively until the pulmonary artery catheter (PAC) is removed (Standard of Care) or discharged, or at study team discretion. At Intensive Care Unit (ICU) admittance and again 3 hours later a straight leg raise will be done to monitor for changes in hemodynamics.

Primary outcomes

  1. Cardiac output values

    Time frame: hour 24

    Cardiac output values correlation of cardiac output between the PA catheter as assessed by the CCO and the VitalStream - the amount of blood pumped by the heart minute - Cardiac output is calculated by multiplying stroke volume with heart rate - Cardiac output in humans is generally 5-6 L/min in an at-rest to more than 35 L/min in elite athletes during exercise. HR is determined by signals from the sinoatrial node, which automatically depolarizes at an intrinsic rate of 60 to 100 times each minute - Low-output symptoms are caused by the inability of the heart to generate enough cardiac output. This leads to reduced blood flow to the brain and other vital organs

  2. Blood pressure values

    Time frame: hour 24

    correlation of blood pressure continuously being monitored by the Vitalstream and the subjects indwelling arterial line

Other outcomes

  1. Assessment of fluid responsiveness changes

    Time frame: Hours 1 and 3

    Assessment of fluid responsiveness using a passive leg raising test (PLR) maneuver, within 1 hour of ICU admission and 3 hours later. We will access fluid challenge using the fluid challenge timer feature on the VitalStream, by doing serial assessments before and after each passive leg raising test.

    PLR is a simple bedside technique that can be used to assess fluid responsiveness. This maneuver can be used as a pseudo-fluid challenge of an approximately of 150-300 mL by placing patient head down flat and feet up at a 45° angle. Blood from the lower extremities translocate to intrathoracic compartment where the right and left ventricular preload increases and if the patient is responsive increases SV and cardiac output. An increase in SV of more than 10% indicates the patient is preload responsive with the high sensitivity and specificity.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 15, 2023
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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