Clinical trial NCT05905536: Perioperative Monitoring of Cardiac Surgery Patients With the Vitalstream Physiological Monitor
Official title: Perioperative Monitoring of Cardiac Surgery Patients With the Vitalstream Physiological Monitor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Output, Low
Stroke Volume
Keywords: cardiac output
cardiac surgery
pulmonary artery catheter
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: OTHER

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiac output values
timeFrame: hour 24
measure: Blood pressure values
timeFrame: hour 24
Secondary outcomes:
Other outcomes:
measure: Assessment of fluid responsiveness changes
timeFrame: Hours 1 and 3
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Ashish Khanna, MD
role: PRINCIPAL_INVESTIGATOR
References: