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

Terminated

• Conditions: Movement, Involuntary
• Interventions: Device: Philips IntelliVue X3 patient monitor with investigational NIBP measurement algorithm (measured once per 3 minutes)

• Registration Number: NCT05185037
• Lead Sponsor: Philips Clinical & Medical Affairs Global

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2021-12-20
• Study First Posted: 2022-01-11
• Study Start: 2022-05-26
• Status Verified: 2023-06
• Primary Completion: 2023-11-16
• Study Completion: 2023-11-16
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 17

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Caesarian Section Patient	Philips IntelliVue X3 patient monitor with investigational NIBP measurement algorithm (measured once per 3 minutes)	Obstetric patient

Primary Outcome Measures

Name	Time	Method
NIBP measurements with no technical alarms/INOPs	1 Visit	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).
NIBP measurements with Diastolic, Systolic, and mean pressure within a physiologically plausible range for the patient population, treatment, and medication	1 Visit	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.
NIBP measurements with pulse pressure greater than 20% of the systolic blood pressure	1 visit	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.

Secondary Outcome Measures

Name	Time	Method
Number of minutes between valid NIBP measurements compared to SoC	1 visit	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.

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States