Validation of the SentiCor-300 Continuous Noninvasive Blood Pressure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Blood Pressure

Intervention / Treatment
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* Device: SentiCor-300


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Accuracy of Continuous Noninvasive Blood Pressure at Various Stages of Anesthesia<br>To compare noninvasive 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 various positions. | Device: SentiCor-300<br>* Continuous blood pressure measurement with the SentiCor-300.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy | The difference between SentiCor-300 and the actual intra-arterial blood pressure for systolic and diastolic pressures. | During hospital admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change | Comparison of continuous arterial pressures obtained from the SentiCor-300 with direct intra-arterial blood pressure measurements during hemodynamic changes at various stages of anesthesia (such as induction, laryngoscopy, maintenance, emergence, and recovery) and after emergence in various postures and positions. | During hospital admission | 
| Calibration Duration | To determine how long an oscillometric calibration of the SentiCor-300 lasts. | During hospital admission | 
| Gender and Fitzpatrick index | To compare perform class analysis on accuracy versus gender and Fitzpatrick index. | During hospital admission |