The purpose of this study is to compare measurements of blood pressure (BP) and fluid responsiveness between the Philips AMC and invasive radial arterial line in surgical patients.
Primary Objective: • To evaluate equivalence of BP measurements (Systolic Blood Pressure \[SBP\], Diastolic Blood Pressure \[DBP\], and Mean Arterial Pressure \[MAP\]) derived from the Philips AMC to the radial arterial line as ground truth. Secondary Objectives: * To evaluate equivalence of Pulse Rate (PR) obtained by the Philips AMC to the radial arterial line as the ground truth. * To evaluate equivalence of Pulse Pressure Variation (PPV) obtained by the Philips AMC to calculated PPV obtained using the radial arterial line waveform pulse pressures as the ground truth. * To evaluate equivalence of Stroke Volume Variation (SVV) obtained by the Philips AMC to calculated SVV (e.g. from a predicate device that uses the radial arterial line waveform) as the ground truth. * To evaluate superiority of blood pressure measurements obtained by the Philips AMC to the oscillometric non-invasive blood pressure (NIBP) cuff, with the radial arterial line as the reference. * To evaluate trending agreement of BP and fluid responsiveness measurements. * To assess time to apply the Philips AMC relative to the radial arterial line. * To assess time from set-up start to first measurement completion between the Philips AMC and radial arterial line. * To collect and report safety data from the Philips AMC. * To collect and report system user experience and satisfaction scores from Philips AMC users. * To create a research dataset with the collected data to use for future hemodynamic algorithm development and validation. Hypothesis: Blood pressure measurements derived from the Philips AMC are equivalent to the radial arterial line and superior to the oscillometric non-invasive blood pressure (NIBP) cuff.
Study Type
OBSERVATIONAL
Enrollment
205
Investigational, non-invasive upper arm cuff
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGDuke University Health System
Durham, North Carolina, United States
RECRUITINGWake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
RECRUITINGPrimary Endpoints
The comparison of systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) between the Philips AMC and radial arterial line.
Time frame: Approximately 8 months accrual and follow-up evaluation period.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
LMU Klinikum
München, Bavaria, Germany
NOT_YET_RECRUITING