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Business decision with slower than expected enrollment..
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caesarian Section Patient | Obstetric patient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Philips IntelliVue X3 patient monitor with investigational NIBP measurement algorithm (measured once per 3 minutes) | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| NIBP measurements with no technical alarms/INOPs | 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). | 1 Visit |
| NIBP measurements with Diastolic, Systolic, and mean pressure within a physiologically plausible range for the patient population, treatment, and medication | 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. | 1 Visit |
| NIBP measurements with pulse pressure greater than 20% of the systolic blood pressure | 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. | 1 visit |
| Measure | Description | Time Frame |
|---|---|---|
| Number of minutes between valid NIBP measurements compared to SoC | 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. | 1 visit |
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Inclusion Criteria:
Exclusion Criteria:
Laboring/Pregnant Females scheduled for Caesarean Section Delivery
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Pregnant Laboring Females scheduled for Caesarean Section Delivery
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| Name | Affiliation | Role |
|---|---|---|
| Aymen Alian, MD | Yale New Haven Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06520 | United States |
Philips does not plan to share IPD data to other researchers.
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|
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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