Fresenius Noninvasive Blood Pressure Validation (BPM2)

Fresenius Noninvasive Blood Pressure Validation - Three Phase Study PR 2020-377

The purpose of this study to collect blood pressure measurement values from the blood pressure measurement device on the Fresenius machine as compared to the standard method.

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Device: Blood Pressure Measurement

Detailed Description

This study is a comparative, single-center, non-randomized comparative study. After IRB approval, the study will be conducted in three Phases. The Fresenius 5008S BPM Module and Cuffs will be evaluated on a minimum of 120 subjects. Three reports will be generated and submitted to different regulatory bodies with the following minimum subject demographics:

• Phase 1: The submission to the United States Food and Drug Administration will include 85 adult and adolescents ages 13 and older.
• Phase 2: The submission to European agencies will contain 50 adult and adolescents ages 13 and older and 35 pediatric subjects ages 3-12.
• Phase 3: The submission to the China Food and Drug Administration will contain 73 adult and adolescents ages 13 and older and 12 pediatric subjects ages 3-12.

Each subject test is expected to take up to 1 hour. Data collection is expected to take 3-6 weeks for Phase 1. Phase 2 and 3 are expected to take an additional 2-4 weeks.

The Auscultator will have a normal audiogram before the study begins. All experimenters will review the protocol prior to test.

Testing will be conducted under normal office environment conditions.

Each subject or their legally authorized representative will be provided an IRB approved Informed Consent. Additionally, subject ages 7 to 17 years, a discussion about the study will be conducted to complete the Assent process for their participation. As applicable, subjects / authorized representatives will be told about any new information that might change their decision to participate. Representatives / subjects who have completed the informed consent and health questionnaire form and meet inclusion/exclusion criteria will be enrolled in the study if they meet desired blood pressure demographics. For Phase 3, an attempt will be made to enroll a person of Chinese origin in each of the cuffs used in the study.

Two trained observers will listen to the Korotkoff sounds at the brachial artery of the arm. The reference blood pressure measurements by the observers will be performed sequentially with the Device Under Test. The Device Under Test memory will be cleared prior to the next determination. In some cases, this may mean powering down the device to clear the previous readings.

The blood pressure measurements will be such that a reference measurement will be alternated with the Device Under Test measurement. The auscultator will wait a minimum of 60 seconds between each blood pressure determination. Each observer's recording of observations of the reference sphygmomanometer shall not be visible to the other observer. The observers will record the exact measurement heard during auscultation and will not round the blood pressure readings. The readings of the Device Under Test shall not be visible to either of these observers.

The observers will complete 1 or 2 initial baseline blood pressure measurements and then 3 to 8 NIBP measurements to be collected for the Accuracy evaluation.

• For Phase 1 and 2, any pair of observers' determinations with a difference greater than 4 mmHg shall be excluded per ANSI/AAMI/ISO 81060-2:2018.
• For Phase 3, any pair of observers' determinations with a difference greater than 10 mmHg shall be excluded and 90% of the observers' determinations shall be within 5 mmHg per YY 0670-2008.

If any determinations are excluded, additional pair(s) of determinations shall be taken to ensure that the needed number of valid test-reference pairs is available (up to a maximum of 8 paired readings) A minimum of 3 valid paired NIBP measurements are needed for the Accuracy analysis. Each subject test is expected to take up to 60 minutes for the enrollment / data collection process.

There are no deviations expected from this investigation plan, should deviations be needed, discussions will be conducted with the sponsoring company, Principal investigator and the IRB will be notified.

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Louisville, Colorado, United States, 80027
      • Clinimark, Site ID#001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
• Subjects must be ≥ 13 years of age for Phase 1.
• Subjects must be ≥ 3 years of age for Phase 2 and 3.
• 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 or write in English.
• Subjects must have an arm circumference in the range of 13-55cm or a thigh circumference in the range of 50-70 cm circumference.
• At least 30% of subjects shall be male and at least 30% of subjects shall be female.

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.
• Subjects with compromised circulation or peripheral vascular disease.
• Subjects with clotting disorders or taking blood thinners.
• Subjects that cannot tolerate sitting for up to 1 hour.
• Subject with a blood pressure demographic that has already been filled.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of Blood Pressure Module (BPM) and Cuffs on the Fresenius Hemodialysis Machine	The Fresenius 5008S BPM with cuffs will be compared to the Reference sphygmomanometer via dual auscultator method. This will be a one-time measurement only no patient follow-up will be performed.	Baseline Comparator

Collaborators and Investigators

• Sponsor: Fresenius Medical Care North America
• Investigators: Principal Investigator: Arthure Cabrera, MD, Avista Adventist Hosptial, Staff Anesthesiologist

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2020
• Primary Completion (Actual): December 4, 2020
• Study Completion (Actual): December 4, 2020

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: PR 2020-377

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No