Blood Pressure, Blood Pressure Measurement
Conditions
Brief summary
The purpose of this study is to collect NIBP and invasive aortic pressure data from the clinical setting.
Detailed description
The purpose of the study is to collect clinical data for validation of the accuracy of non-invasive blood pressure (NIBP) measurement algorithms on the Non-invasive Blood Pressure (NIBP) Standard Parameter Module (SPM) per IEC 80601-2-30:2018, Medical electrical equipment-Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers standard, section 201.106. In addition, the study will be conducted per ISO 81060-2:2018+AMD2:2024 Non-invasive sphygmomanometers-Part 2: Clinical investigation of intermittent automated measurement type.
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.
Sponsors
GE Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age requirement: 18 and over. 2. 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). 3. Have an arterial line as a standard of care, which measures blood pressure at the aortic root. 4. Able to provide written informed consent. 5. Expected to remain in the unit for the duration of the study procedure.
Exclusion criteria
1. Have previously participated in this study (no subject may participate more than once). 2. Pregnant and lactating women per site standard of care. 3. Subjects with peripheral arterial diseases (causing left/right arm difference) 4. Hemodynamically unstable subjects at the discretion of the investigator. 5. Exhibited injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the Investigator, may prevent proper cuff application or functioning. 6. Are suffering from infection(s) or immunocompromised patients that require isolation. 7. PI or designee decision due to subject health conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure | Up to 2 hours after time of enrollment | Collection of non-invasive blood pressure measurements data from subjects in clinical setting. |
Countries
Finland
Outcome results
None listed