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

NCT05654714 | Terminated Results

• 1 other identifier: 60115909
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  Day 1 (up to 1 hour)

Study Arms (1)

Blood pressure readings

EXPERIMENTAL

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.

Device: ModPG3 Investigational Device; Device: Auscultatory Equipment

Interventions

ModPG3 Investigational Device 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

Blood pressure readings

Auscultatory Equipment DEVICE

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

Blood pressure readings

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Welch Allyn: lead

Study Sites (1)

Baxter Investigational Site

Bologna, 40138, Italy

Location

Limitations and Caveats

This study was terminated early due to errors in the StepBP Algorithm 9104.16 and SureBP Algorithm 9305.10 from data gathered outside this study. The sponsor made the decision to update the software, which may have an impact on the data. Due to early termination of the study, efficacy analysis was not completed, thus no scientific conclusions can be drawn from this study.

Results Point of Contact

• Title: Jessica Gregory
• Organization: Baxter

jessica_gregory@baxter.com

N/A

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 16, 2022
• Study Start: March 6, 2023
• Primary Completion: November 9, 2023
• Study Completion: November 9, 2023
• Last Updated: November 19, 2025
• Results First Posted: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Upon approval of a legitimate research request.
• Access Criteria: Research requests will be reviewed by qualified medical and scientific experts within the company. If Baxter agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality and any intellectual property rights of Baxter prior to the release of any data.

Locations

IT (1)