ModPG3 Adult/Ped ISO 81060-2:2018 Study Protocol

Welch Allyn

Status: Terminated

Conditions: Blood Pressure

Treatments: Device: Auscultatory Equipment; Device: ModPG3 Investigational Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05654714

60115909

Details and patient eligibility

About

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

Enrollment: 152 patients

Sex: All

Ages: 3+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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152 participants in 1 patient group

Blood pressure readings

Experimental group

Description:

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.

Treatment:

Device: ModPG3 Investigational Device

Device: Auscultatory Equipment