Cardiac Output, Low Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 46 |
Est. completion date | August 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Assessment of fluid responsiveness changes | 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. |
Hours 1 and 3 | |
Primary | 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 | |
Primary | Blood pressure values | correlation of blood pressure continuously being monitored by the Vitalstream and the subjects indwelling arterial line | hour 24 |
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