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

Philips

Status

Terminated

Conditions

Movement, Involuntary

Treatments

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

Study type

Observational

Funder types

Industry

Identifiers

NCT05185037

MA_PM_NIBP_AE__2021_11266

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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