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

Philips Clinical & Medical Affairs Global17 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Movement, Involuntary

Interventions

Philips IntelliVue X3 patient monitor with investigational NIBP measurement algorithm (measured once per 3 minutes)DEVICE

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Yale University

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

NIBP measurements with no technical alarms/INOPs

Time frame: 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.

Time frame: 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.

Time frame: 1 visit

Secondary Outcomes

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.

Time frame: 1 visit

Data from ClinicalTrials.gov

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