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

Movement, Involuntary Clinical Trial

Official title:

NIBP Algorithm Enhancements - MA_PM_NIBP Algorithm Enhancements_2021_11266

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05185037
• Other study ID #: MA_PM_NIBP_AE__2021_11266
• Status: Terminated
• Start date: May 26, 2022
• Est. completion date: November 16, 2023

Study information

• Verified date: June 2023
• Source: Philips Clinical & Medical Affairs Global
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: November 16, 2023
• Est. primary completion date: November 16, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyskinesias
• Movement, Involuntary

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	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