NIBP (Non-invasive Blood Pressure) Algorithm Enhancements (Characterize the Robustness of Motion Artifact Suppression)
NCT ID: NCT05185037
Last Updated: 2024-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
17 participants
OBSERVATIONAL
2022-05-26
2023-11-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Caesarian Section Patient
Obstetric patient
Philips IntelliVue X3 patient monitor with investigational NIBP measurement algorithm (measured once per 3 minutes)
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
Interventions
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Philips IntelliVue X3 patient monitor with investigational NIBP measurement algorithm (measured once per 3 minutes)
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Philips Clinical & Medical Affairs Global
INDUSTRY
Responsible Party
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Principal Investigators
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Aymen Alian, MD
Role: PRINCIPAL_INVESTIGATOR
Yale New Haven Hospital
Locations
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Yale University
New Haven, Connecticut, United States
Countries
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Other Identifiers
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MA_PM_NIBP_AE__2021_11266
Identifier Type: -
Identifier Source: org_study_id
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