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

Sponsor
Norbert Health (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05640323
Collaborator
Northwell Health (Other)
30
Enrollment
1.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 study will be conducted within an Emergency Department where each subject is assigned an Emergency Severity Index (ESI) score. Only subjects with ESI scores ranging from 3-5 will be recruited for the study to prevent intervening with standard patient care. 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 Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Pulse Rate
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Root Mean Square Error (RMSE) [Up to 1 hour]

    RMSE will be evaluated by comparing the pulse rate computed by the Norbert Device to the heart rate measured from the RCECG.

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Male or female subjects aged 22 or over

  • Ability to provide signed informed consent

  • ESI score of 3-5

Exclusion Criteria:

  • Pregnant

  • ESI of 1-2

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Norbert Health
  • Northwell Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Norbert Health
ClinicalTrials.gov Identifier:
NCT05640323
Other Study ID Numbers:
  • NCP-0002
First Posted:
Dec 7, 2022
Last Update Posted:
Jan 23, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Norbert Health
medical device
validation
arrhythmia
ECG
pulse rate
Norbert Device
Norbert Health
Additional relevant MeSH terms:
Arrhythmias, Cardiac

Study Results

No Results Posted as of Jan 23, 2023