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

NCT ID: NCT05654714

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-06
• Study Completion Date: 2023-11-09

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

Conditions

Blood Pressure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ModPG3 Investigational Device

Intervention Type: 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

Intervention Type: DEVICE

• Reference Sphygmomanometer1
• Reference Cuffs2
• Dual Auscultatory Stethoscope
• Tape measure
• Stopwatch

Interventions

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

Intervention Type: DEVICE

Auscultatory Equipment

• Reference Sphygmomanometer1
• Reference Cuffs2
• Dual Auscultatory Stethoscope
• Tape measure
• Stopwatch

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Welch Allyn

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Baxter Investigational Site

Bologna, , Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

60115909

Identifier Type: -

Identifier Source: org_study_id