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The purpose of this study is developing new NIBP enhancement and test it in clinical environment with neonates and children population subjects.
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 |
|---|---|---|---|
| Child Cuff vs Small Adult Cuff (Upper arm overlap, 17-19 cm) | Active Comparator | Subjects with an upper-arm circumference within 17-19 cm, where both Child Cuff and small adult cuffs are suitable, are randomized in a 1:1 ratio to receive blood pressure measurements using either: Child Cuff or Small Adult cuff Subjects with upper-arm circumferences in non-overlapping small adult -only ranges are assigned the Small Adult cuff without randomization and are not included in this arm. |
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| Small Adult vs Adult Cuff (Upper arm overlap, 23-25cm) | Active Comparator | 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: -Small Adult cuff, or -Adult cuff 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. |
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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 12 hours from time of study procedure start |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome | 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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Otto Rahkonen Principal Invastigator | Contact | +35894711 | otto.rahkonen@hus.fi |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Recruiting | Helsinki | 00290 | Finland |
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| Helsinki University Hospital | Recruiting | Helsinki | 00290 | Finland |
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