Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Pulse Rate

The study will evaluate the mean average error (MAE) of measuring pulse rate using the Norbert Device (ND) as compared to a reference heart rate measured using an electrocardiogram (ECG).

Study Overview

• Status: Completed
• Conditions: Healthy; Arrhythmia
• Intervention / Treatment: Device: Norbert Device

Detailed Description

The study design is to validate the pulse and heart rate accuracy as required per ISO 80601-2-61, Clause 201.12.1.104. The study is a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the ND's pulse rate measurement compared to a reference heart rate manually measured by observing R-peaks in a standard concurrently recorded ECG from an FDA 510(k)-cleared reference clinical ECG (RCECG). The sponsor will ensure that the study staff enrolls a range of types of arrhythmias including tachycardia, bradycardia, atrial fibrillation, bigeminy, trigeminy, and others.

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

• Study Contact: Name: Ellie Gonzalez; Phone Number: 503-4001722; Email: ellie.gonzalez@norberthealth.com

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11205
      • Newlab
    • Staten Island, New York, United States, 10305
      • Staten Island University Hospital
      • Principal Investigator: Barry Hahn, MD
      • Contact: Kimberly Nemai; Email: knemai@northwell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study will recruit subjects within an Emergency Department as well as through online internet bulletin boards.

Description

Inclusion Criteria:

• Male or female subjects aged 18 or over
• Ability to provide signed informed consent

Exclusion Criteria:

• Pregnant
• Otherwise deemed unsuitable to participate in the study based on judgment of the study investigator

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Average Error (MAE)	MAE will be evaluated by Mean absolute error (MAE) of the pulse rate of the device compared to the heart rate measured from the RCECG.	Up to 1 hour

Collaborators and Investigators

• Sponsor: Norbert Health
• Collaborators: Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2023
• Primary Completion (Actual): October 4, 2023
• Study Completion (Actual): October 20, 2023

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: medical device; arrhythmia; ECG; validation; Norbert Device; Norbert Health; pulse rate
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: NCP-0002

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