NIBP (Non-invasive Blood Pressure) Algorithm Enhancements (Characterize the Robustness of Motion Artifact Suppression)

Study Overview
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Brief Summary
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The study intervention consists of a non-invasive blood pressure (NIBP) measurement device and cuff (FDA-cleared Philips IntelliVue X3 Rev. N.04 patient monitor) running a non-approved modified software containing an enhanced measurement algorithm for NIBP.

Detailed Description
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The purpose of this study is to compare measurements of NIBP taken by the study device and measurements taken by the current FDA-approved algorithm included in Rev. N.0 software for the IntelliVue patient monitors during motion artifact in patients undergoing caesarian section deliveries under epidural anesthesia.

Official Title
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NIBP Algorithm Enhancements - MA_PM_NIBP Algorithm Enhancements_2021_11266

Conditions
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Movement, Involuntary

Intervention / Treatment
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* Device: Philips IntelliVue X3 patient monitor with investigational NIBP measurement algorithm (measured once per 3 minutes)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obstetric patient at Yale New Haven Hospital Receiving epidural anesthesia Age at least 18 years Willing and able to provide informed consent in a Sponsor approved language Willing and able to comply with study-related procedures Priority classification II, III, or IV Exclusion Criteria: Non-caesarian section deliveries Ruptured uterus, prolonged fetal bradycardia, cord prolapse, or other emergent condition Procedures under general anesthesia Altered mental status Currently participating in another clinical trial with any product, treatment and/or medication that clinically interferes with the study endpoint(s) Priority classification I or V

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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 |
| --- | --- |
| Caesarian Section Patient<br>Obstetric patient | Device: Philips IntelliVue X3 patient monitor with investigational NIBP measurement algorithm (measured once per 3 minutes)<br>* The purpose of this study is to compare measurements of NIBP taken by the study device and measurements taken by the current FDA-approved algorithm included in Rev. N.0 software for the IntelliVue patient monitors during motion artifact in patients undergoing caesarian section deliveries under epidural anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIBP measurements with no technical alarms/INOPs | The primary endpoint for this study is the rate of NIBP measurements that are valid based on evaluation by a panel of three independent, licensed physicians. Valid measurement will include no technical alarm (INOP). | 1 Visit | 
| NIBP measurements with Diastolic, Systolic, and mean pressure within a physiologically plausible range for the patient population, treatment, and medication | The primary endpoint for this study is the rate of NIBP measurements that are valid based on evaluation by a panel of three independent, licensed physicians. Valid measurement will include Diastolic, Systolic, and mean pressures within a physiologically plausible range for the patient population, treatment and medication. | 1 Visit | 
| NIBP measurements with pulse pressure greater than 20% of the systolic blood pressure | The primary endpoint for this study is the rate of NIBP measurements that are valid based on evaluation by a panel of three independent, licensed physicians. Valid measurement will include pulse pressure greater than 20% of the systolic blood pressure. | 1 visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of minutes between valid NIBP measurements compared to SoC | The secondary endpoint for this study is the number of minutes between valid measurements for the investigational device as compared to the standard of care device. | 1 visit |