Validation of Three Non-invasive Hemodynamic Monitoring Systems for Determining Measures of Volume Responsiveness, Ventriculo-arterial Coupling and Cardiac Output
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Stroke Volume Variation
Study Overview
Brief Summary
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?
Detailed Description
Investigators will compare predictors of preload responsiveness, including pulse pressure variation (PPV) and stroke volume variation (SVV), and arterial dynamic elastance (Eadyn) in all patients and estimates of cardiac output (CO) in patients with an indwelling pulmonary artery catheter. in 50 intensive care unit, intubated patients during the patient's normal course of treatment using their usually present invasive monitoring devices for the first 8 hours following cardiac surgery.
The primary goal of the study will be to compare PPV, SVV and Eadyn measured by the non-invasive monitors ClearSight, CareTaker and CNAP versus a reference standard that uses invasive arterial pressure waveform data, which in this case will be the LiDCO monitor & FloTrac monitor. Investigators will calculate accuracy, precision and concordance of each of the parameters measured during steady state conditions and after specific interventions including the administration of crystalloid fluid boluses and changes in vasoactive or inotropic medications. As a secondary objective, investigators will compare measures of CO by the same non-invasive monitors with the pulmonary artery catheter as a reference standard during the same conditions as above (i.e., steady state conditions, and before/after interventions). CO will therefore be only compared in patients that have a pulmonary artery catheter in place.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to 105 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients (18 years and older)
- •Male and female patients following cardiac surgery admitted to the CTICU with or without a pulmonary artery catheter
Exclusion Criteria
- •Subjects whose sternum remains open post-surgery and/or the presence of a LV ventricular assist device.
- •Presence of a any ventricular assist device, ECMO, Impella, durable LVAD, or central L/RVAD.
- •Spontaneous breathing activity upon coming out of the operating room (i.e., patients extubated in the operating room).
- •Presenting chronic atrial fibrillation, refractory acute atrial fibrillation to medical therapy or frequent extra-systoles.
- •Children will be excluded from this study. The hospital unit where all subjects will be recruited is for adults' (ages 18 and up) only. Gender, racial and ethnic sub groups will not be explicitly excluded.
Outcomes
Primary Outcomes
Stroke Volume Variation
Time Frame: 8 hours
The Stroke Volume Variation (SSV) will be collected continuously for 8 hours using all 3 devices (ClearSight, CareTaker and CNAP). The metric of performance will be the precision, accuracy and concordance assessed using Bland Altman analysis and Pearson's moment analysis comparing SVV from each of the non-invasive monitors with the reference standard obtained from the analysis of the arterial pressure waveform. Measurement of SVV, PPV, Eadyn and CO from non-invasive monitors will be obtained continuously, but the quantity will be recorded at different timepoints including: Baseline, every 30 min after baseline, before each bolus of crystalloid fluid or blood product (within 5 minutes of administration, after each bolus of crystalloid fluid or blood product (within 5 minutes of stopping), before each change in vasopressors or inotropes (within 5 minutes of administration), after each change in vasopressors or inotropes (within 5 minutes of stopping), before changing ventilatory mode.
Pulse Pressure Variation (PPV)
Time Frame: 8 hours
The Pulse Pressure Variation will be collected continuously for 8 hours using all 3 devices (ClearSight, CareTaker and CNAP). The metric of performance will be the precision, accuracy and concordance assessed using Bland Altman analysis and Pearson's moment analysis comparing PPV from each of the non-invasive monitors with the reference standard obtained from the analysis of the arterial pressure waveform. This metric of performance will be reported. The most reliable device will be based on the metric of performance - that is, the most precise, accurate and concordant. Measurement of SVV, PPV, Eadyn and CO from non-invasive monitors will be obtained continuously, but the quantity will be recorded at different timepoints including: Baseline, every 30 min after baseline, before each bolus of crystalloid fluid or blood product (within 5 minutes of administration, after each bolus of crystalloid fluid or blood product (within 5 minutes of stopping), before each change in vasopressors.
Arterial Dynamic Elastance (Eadyn)
Time Frame: 8 hours
The Arterial Dynamic Elastance (Eadyn) will be collected continuously for 8 hours using all 3 devices (ClearSight, CareTaker and CNAP). The metric of performance will be the precision, accuracy and concordance assessed using Bland Altman analysis and Pearson's moment analysis comparing Eadyn from each of the non-invasive monitors with the reference standard obtained from the analysis of the arterial pressure waveform. This metric of performance will be reported. The most reliable device will be based on the metric of performance - that is, the most precise, accurate and concordant. Measurement of SVV, PPV, Eadyn and CO from non-invasive monitors will be obtained continuously, but the quantity will be recorded at different timepoints including: Baseline, every 30 min after baseline, before each bolus of crystalloid fluid or blood product (within 5 minutes of administration, after each bolus of crystalloid fluid or blood product (within 5 minutes of stopping).
Secondary Outcomes
- Cardiac Output(8 hours)
- Volume Responsiveness Collection(8 hours)
Investigators
Hernando Gomez
Associate Professor
University of Pittsburgh