Validation of the SentiCor-300 Continuous Noninvasive Blood Pressure

Clinical Validation of the SentiCor-300 Continuous Noninvasive Blood Pressure Against Invasive Arterial Blood Pressure

To compare continuous arterial pressures obtained from the SentiCor-300 with direct intra-arterial blood pressure measurements at various stages of anesthesia (such as induction, laryngoscopy, maintenance, emergence, and recovery) and after emergence in supine position.

Analysis of number and magnitude of BP changes Adjust endpoint calculation definitions and methods based on this lead in results Estimate sample size for main study Demonstration of capability to quantify and annotate interference in the arterial line signal and detect and changes in patient orientation Parallel recording of SentiCor-300 PPG sensor

Main study:

Validate SentiCor-300 noninvasive blood pressure against direct arterial pressure measurements.

Up to 200 (10 run-in, the balance- study) Run in phase will be performed with Senticor-100, data will be used for sample size estimation of balance study.

Inclusion Criteria:

• Clinical indication for arterial catheter insertion;
• Age ≥18 years;
• American Society of Anesthesiologists (ASA) physical status class ≤3;
• Enrollment will be adjusted as necessary so the final population includes at least 40% men and 40% women;
• Planned length of surgery >60 minutes;
• Anticipated supine positioning;
• Anticipated initial recovery in the post-anesthesia care unit.

Exclusion criteria:

• Severe peripheral vascular disease;
• Surgery that involves manipulation of large arteries
• Bypass surgery
• Positive Allen's test
• Inability to insert a catheter into an upper extremity artery;
• Patients with an arterial-venous shunt for hemodialysis;
• Inability to measure NIBP on the arm with the arterial catheter;
• Atria l fibrillation;
• Body Mass Index (BMI) >35kg/m2;
• Esophageal or nasopharyngeal pathology, coarctation of the aorta;
• Emergency surgery.
• Surgery which involves manipulation of major arteries