Perioperative Monitoring of Cardiac Surgery Patients With the Vitalstream Physiological Monitor

NCT05905536 | Completed DMC FDA Device

• 1 other identifier: IRB00096075
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Output, Low; Stroke Volume

Keywords

cardiac output; cardiac surgery; pulmonary artery catheter

Outcome Measures

Primary Outcomes (2)

• Cardiac output values

  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

  hour 24

• Blood pressure values

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

  hour 24

Other Outcomes (1)

• Assessment of fluid responsiveness changes

  Hours 1 and 3

Study Arms (1)

Vitalstream

EXPERIMENTAL

Device placed on the subject preoperatively in the holding room and continued postoperatively into the Cardiac Intensive Care Unit (ICU).

Device: Vitalstream

Interventions

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.

Vitalstream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ashish Khanna, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cardiac patient population through the major part of their continuum of care, with monitoring starting at the start of the subjects holding room pre-operative preparation and continuing through surgery to recovery in the Cardiovascular Intensive Care Unit (CVICU), where monitoring will continue until the pulmonary artery catheter (PAC) is removed

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 15, 2023
• Study Start: August 15, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: August 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)