RecruitingNot ApplicableNCT07697950
NIBP Accuracy Study for Adult Subject Populations
Non-Invasive Blood Pressure Accuracy Study for Adult Subject Populations
Sponsor
GE Healthcare
Enrollment
130 participants
Start Date
Jan 13, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to collect NIBP and invasive aortic pressure data from the clinical setting.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- Age requirement: 18 and over.
- Have an upper limb (right OR left side) that fits the cuff size of the device (circumference ranging 17 cm to 40 cm) OR have a thigh (right OR left side) that fits a cuff size of the device (circumference ranging 38 to 50 cm).
- Have an arterial line as a standard of care, which measures blood pressure at the aortic root.
- Able to provide written informed consent.
- Expected to remain in the unit for the duration of the study procedure.
Exclusion Criteria7
- Have previously participated in this study (no subject may participate more than once).
- Pregnant and lactating women per site standard of care.
- Subjects with peripheral arterial diseases (causing left/right arm difference)
- Hemodynamically unstable subjects at the discretion of the investigator.
- Exhibited injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the Investigator, may prevent proper cuff application or functioning.
- Are suffering from infection(s) or immunocompromised patients that require isolation.
- PI or designee decision due to subject health conditions
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DEVICENIBP Measurement
The collection of non-invasive blood pressure measurements using NIBP Standard Parameter Module with SuperSTAT algorithm with simultaneous invasive blood pressure waveform recordings per discretion of the sponsor upon combining the data from other clinical studies to comply with ISO 81060-2:2018 +AMD2:2024.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07697950
Related Trials
Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
NCT0724083111 locations
Potatoes, Type 2 Diabetes, and Cardiometabolic Health
NCT072294821 location
The Venous Distension Reflex and Orthostatic Hypertension
NCT034967921 location
Autonomic Control of the Circulation and VDR
NCT035137701 location
AI-Guided Predictions of Blood Pressure Dysregulation Using Perfusion Index as a Novel Biomarker in Persons With Spinal Cord Injury
NCT076990941 location