Philips Clinical & Medical Affairs Global
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 equiv…
Inclusion Criteria: * Adults aged 18 years and older * Indication for NIBP cuff * Indication for a radial arterial line * Subject or legal authorized representative is able to understand and speak the local language (also Spanish for US sites) to provide voluntary written informed consent prior to study procedures The following stratification criteria must be met across the study sites and hence targeted enrollment may be required: * Age of every patient 18+; at least 30% \> 65 years, 30% ≤ 65 years * At least 30% male, 30% female * Minimum number of subjects needed to test each size cuff (…
Investigational, non-invasive upper arm cuff
Arctuva estimate
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