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

NCT05185037 | Terminated FDA Device

• 1 other identifier: MA_PM_NIBP_AE__2021_11266
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Movement, Involuntary

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Number of minutes between valid NIBP measurements compared to SoC

  1 visit

Study Arms (1)

Caesarian Section Patient

Obstetric patient

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

Interventions

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

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

Caesarian Section Patient

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Laboring/Pregnant Females scheduled for Caesarean Section Delivery
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant Laboring Females scheduled for Caesarean Section Delivery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Dyskinesias

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aymen Alian, MD

  Yale New Haven Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 11, 2022
• Study Start: May 26, 2022
• Primary Completion: November 16, 2023
• Study Completion: November 16, 2023
• Last Updated: January 5, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)