Non-Invasive Blood Pressure Accuracy Study for Adult Subject Populations
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGE Healthcare
About this trial
The purpose of this study is to collect NIBP and invasive aortic pressure data from the clinical setting.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
NIBP Measurement
DeviceThe 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.
Treatment groups
130 Participants
are divided into 3 treatment groupsGroup A: Small Adult vs Adult Cuff (Upper Arm, Overlap Range 23-25 cm)Experimental treatment 1 intervention
Group B: Adult vs Large Adult Cuff (Upper Arm, Overlap Range 31-33 cm)Experimental treatment 1 intervention
Group C: Thigh Cuff (Fallback/Non-Randomized)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Outcome Measure
Collection of non-invasive blood pressure measurements data from subjects in clinical setting.
Time frame
Up to 2 hours after time of enrollmentOther outcomes
1
Incidence of Safety Events
Analysis of adverse events will be listed per subject, summarized with counts and percentages of events, and summarized with counts and percentages of subjects with events.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov