Blood Pressure
Conditions
Brief summary
Automated blood pressure cuff measurements taken by an oscillometric device is the standard in numerous medical settings today. Studies show that oscillometric devices using algorithms are more accurate and consistent than devices using other non-invasive measuring techniques, especially in critical cases. SureBP algorithm estimates BP during cuff inflation; the second, StepBP algorithm does so during deflation. The purpose of this study is to test the algorithms contained in the ModPG3 on Adult and Pediatric subjects to determine if they meet the requirements of ISO 81060-2:2018/Amd 1:2020 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
Interventions
* Connex Vital Sign Monitor with ModPG3 * Laptop * Blood Pressure Data Collection Software (not used for test report analysis) * USB cable * Power strip * Welch Allyn FlexiPort Reusable Blood Pressure Cuffs
DEVICEAuscultatory Equipment
* Reference Sphygmomanometer1 * Reference Cuffs2 * Dual Auscultatory Stethoscope * Tape measure * Stopwatch
Sponsors
Welch Allyn
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects must be able to provide an informed consent or have legally authorized representative consent to participate. * Subject must be willing and able to comply with the study procedures. * Subject must be ≥ 3 years of age * Subjects that are between 7 and 17 years of age must provide assent to participate in the study. * Subject or legally authorized representative must be able to read, write, speak in English, French or Italian. * Subjects must have an arm circumference in the range of 12-55 cm and fit into the usable range for the reference cuffs. * Subject must be able to have blood pressures measured on the Left arm.
Exclusion criteria
* Lack of Informed consent. * Subjects with deformities or abnormalities that may prevent proper application of the device under test. * Subject is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study. * Subjects with known heart dysrhythmias. * The subject is in acute distress, i.e., severe pain or, severe emotional distress or agitation that would inhibit him/her from participating in the study. * The subject has any known contraindication to blood pressure measurement. * Subjects with compromised circulation or peripheral vascular disease. * Subjects with clotting disorders or taking prescribed blood thinners. * Subjects that cannot tolerate sitting for up to 1 hour. * Subject with a blood pressure demographic that has already been filled. * Subjects with a severe contact allergy to cuff material. * Subjects with a history of skin fragility or breakdown, such as ecchymosis or lacerations, affecting the upper extremities that would affect the application of noninvasive blood pressure cuff. * Subjects whose arm circumference does not fall within the unusable range for the reference cuffs. * Subjects with no audible K5 sound. * Subject is pregnant and/or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance of the ModPG3 Blood Pressure (BP) Readings With ISO Requirements | Day 1 (up to 1 hour) | BP readings for all subjects will be calculated separately for systolic and diastolic blood pressure. At least three paired blood pressure values shall be taken for each subject. ISO 81060-2:2018/Amd 1:2020 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Blood Pressure Readings The study will be conducted in 2 parts.
* Part 1 will test subjects using the ModPG3 Investigational device with the SureBP algorithm enabled.
* Part 2 will test subjects using the ModPG3 Investigational device with the StepBP algorithm enabled.
The study requires three observers. The first two observers take auscultatory readings that are averaged to use as reference blood pressures. The third observer operates the ModPG3 investigational device and records the readings for that device.
The two clinicians taking reference readings will be blinded to each other's readings and to the investigational device readings.
ModPG3 Investigational Device: • Connex Vital Sign Monitor with ModPG3
* Laptop
* Blood Pressure Data Collection Software (not used for test report analysis)
* USB cable
* Power strip
* Welch Allyn FlexiPort Reusable Blood Pressure Cuffs
Auscultatory Equipment: • Reference Sphygmomanometer1
* Reference Cuffs2
* Dual Auscultatory Stethoscope
* Tape measure
* Stopwatch | 152 |
| Total | 152 |
Baseline characteristics
| Characteristic | Blood Pressure Readings | — |
|---|---|---|
| Age, Customized >= 18 years | 95 Participants | — |
| Age, Customized 3 - 17 years | 57 Participants | — |
| Arm Circumference of ≥12-55 cm | 152 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Italy | 152 participants | — |
| Sex: Female, Male Female | 64 Participants | — |
| Sex: Female, Male Male | 88 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 152 |
| other Total, other adverse events | 0 / 152 |
| serious Total, serious adverse events | 0 / 152 |
Outcome results
Primary
Compliance of the ModPG3 Blood Pressure (BP) Readings With ISO Requirements
BP readings for all subjects will be calculated separately for systolic and diastolic blood pressure. At least three paired blood pressure values shall be taken for each subject. ISO 81060-2:2018/Amd 1:2020 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
Time frame: Day 1 (up to 1 hour)
Population: The study was terminated due to errors in the algorithm planned for data processing and analysis. A validated post processing algorithm for the raw data files was never finalized, so no blood pressure measurements needed for analysis are available. There is no data available to populate the outcome measure.