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Recruiting NCT07697950

NIBP Accuracy Study for Adult Subject Populations

No phase Interventional Blood Pressure Measurement Blood Pressure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NIBP Measurement.
Who it may be relevant to
Registry conditions: Blood Pressure Measurement, Blood Pressure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Non-Invasive Blood Pressure Accuracy Study for Adult Subject Populations

Overview

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

  • Device NIBP 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.

Primary outcome measures

  • Primary Outcome Measure [Time frame: Up to 2 hours after time of enrollment]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Finland · 1 center
  • Tower Hospital, the Heart and Lung Center — Helsinki

Publications

  • 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 PMID 30354655
  • 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. PMID 29359130

Identifiers

NCT: NCT07697950 · SA-000068

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗