Fresenius Noninvasive Blood Pressure Validation

NCT04573595 | Completed FDA Device

• 1 other identifier: PR 2020-377
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Blood Pressure Measurement DEVICE

The purpose of this study is to provide supporting documentation for Noninvasive blood pressure measurement accuracy claims for Fresenius 5008S BPM Module and Cuffs on the intended population(s). The same arm sequential method with dual observer auscultation will be used to collect data.

Eligibility Criteria

• Age: 13 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.
• 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.

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.
• 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.

Sponsors & Collaborators

• Fresenius Medical Care North America: lead

Study Sites (1)

Clinimark, Site ID#001

Louisville, Colorado, 80027, United States

Location

MeSH Terms

Interventions

Blood Pressure Determination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Physical Examination

Study Officials

• Arthure Cabrera, MD

  Avista Adventist Hosptial, Staff Anesthesiologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The purpose of this study is to provide supporting documentation for Noninvasive blood pressure measurement accuracy claims for Fresenius 5008S BPM Module and Cuffs on the intended population(s). The same arm sequential method with dual observer auscultation will be used to collect data.

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: October 5, 2020
• Study Start: September 17, 2020
• Primary Completion: December 4, 2020
• Study Completion: December 4, 2020
• Last Updated: February 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)