Movement, Involuntary
Conditions
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.
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 patient monitors during motion artifact in patients undergoing caesarian section deliveries under epidural anesthesia.
Interventions
DEVICEPhilips 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
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NIBP measurements with no technical alarms/INOPs | 1 Visit | 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). |
| NIBP measurements with Diastolic, Systolic, and mean pressure within a physiologically plausible range for the patient population, treatment, and medication | 1 Visit | 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. |
| NIBP measurements with pulse pressure greater than 20% of the systolic blood pressure | 1 visit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of minutes between valid NIBP measurements compared to SoC | 1 visit | The secondary endpoint for this study is the number of minutes between valid measurements for the investigational device as compared to the standard of care device. |
Countries
United States
Outcome results
None listed