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

  • STATUS
    Recruiting
  • days left to enroll
    22
  • participants needed
    106
  • sponsor
    Philips Clinical & Medical Affairs Global
Updated on 7 October 2022

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.

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.

Details
Condition Movement, Involuntary
Treatment Philips IntelliVue X3 patient monitor with investigational NIBP measurement algorithm (measured once per 3 minutes)
Clinical Study IdentifierNCT05185037
SponsorPhilips Clinical & Medical Affairs Global
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
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