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The purpose of this study is to collect NIBP and invasive aortic pressure data from the clinical setting.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Small Adult vs Adult Cuff (Upper Arm, Overlap Range 23-25 cm) | Experimental | Subjects with an upper-arm circumference within 23-25 cm, where both Small Adult (SA) and Adult (A) cuffs are suitable, are randomized in a 1:1 ratio to receive blood pressure measurements using either:
Subjects with upper-arm circumferences in non-overlapping SA-only ranges are assigned the Small Adult cuff without randomization and are not included in this arm. |
|
| Adult vs Large Adult Cuff (Upper Arm, Overlap Range 31-33 cm) | Experimental | Subjects with an upper-arm circumference within 31-33 cm, where both Adult (A) and Large Adult (LA) cuffs are suitable, are randomized in a 1:1 ratio to receive blood pressure measurements using either: Adult cuff, or Large Adult cuff Subjects with measurements in non-overlapping A-only or LA-only ranges are assigned the appropriate cuff without randomization and are not included in this arm. |
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| Thigh Cuff (Fallback/Non-Randomized) | Experimental | Subjects whose arm circumference is either:
will undergo thigh circumference measurement. Those with a thigh circumference within 38-50 cm will receive blood pressure measurements using a thigh cuff. Subjects outside the thigh circumference range are excluded prior to any blood pressure measurements. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIBP Measurement | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measure | Collection of non-invasive blood pressure measurements data from subjects in clinical setting. | Up to 2 hours after time of enrollment |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampere Heart Hospital | Recruiting | Tampere | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29359130 | Background | Meidert AS, Saugel B. Techniques for Non-Invasive Monitoring of Arterial Blood Pressure. Front Med (Lausanne). 2018 Jan 8;4:231. doi: 10.3389/fmed.2017.00231. eCollection 2017. | |
| 30354655 | Background | Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2018 Oct 23;138(17):e426-e483. doi: 10.1161/CIR.0000000000000597. No abstract available. |
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