Status:
TERMINATED
NIBP (Non-invasive Blood Pressure) Algorithm Enhancements (Characterize the Robustness of Motion Artifact Suppression)
Lead Sponsor:
Philips Clinical & Medical Affairs Global
Conditions:
Movement, Involuntary
Eligibility:
FEMALE
18+ years
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 softwa...
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 pat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 26 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 16 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT05185037
Start Date
May 26 2022
End Date
November 16 2023
Last Update
January 5 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale University
New Haven, Connecticut, United States, 06520