Pulse Rate and Breathing Rate Accuracy

Description

The purpose of this study is to conduct a Breathing Rate and Pulse Rate accuracy validation comparing the NuraLogix AMC-SDK to the Reference devices, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) and a standard ECG (GE Datex-Ohmeda) derived heart rate reference. This will be done by manually scoring the collected waveform for data analysis.

Conditions

Pulse Rate and Breathing Rate

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Study Overview

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Study Details

Study overview

The purpose of this study is to conduct a Breathing Rate and Pulse Rate accuracy validation comparing the NuraLogix AMC-SDK to the Reference devices, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) and a standard ECG (GE Datex-Ohmeda) derived heart rate reference. This will be done by manually scoring the collected waveform for data analysis.

Pulse Rate and Breathing Rate Accuracy Study - NuraLogix AMC-SDK

Pulse Rate and Breathing Rate Accuracy

Condition
Pulse Rate and Breathing Rate
Intervention / Treatment

-

Contacts and Locations

Louisville

Element Materials Technology, Louisville, Colorado, United States, 80027

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participants must have the ability to understand and provide written informed consent or have legally authorized representative consent to participate
  • * Participant must be 18 to 81 years of age (≥ 18 age to \< 82)
  • * Participant must be willing and able to comply with study procedures and duration
  • * Participants or legally authorized representative must be able to read or write in English
  • * Participants who refuse or are unable to provide to sign an informed written consent for study
  • * Participants evaluated by the Investigator and Clinical Staff and found to be medically - unsuitable or have self-reported health conditions that are currently unstable as identified in the Health Assessment Form and Health Screening
  • * Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor Region of Interest (ROI) which would limit the ability to test ROI needed for the study. Tattoo in the optical path which would limit the ability to test ROI needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the particular areas utilized.)
  • * Participants with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, or other medical sensors (self- reported)
  • * Other known health condition, should be considered upon disclosure in health assessment form

Ages Eligible for Study

18 Years to 81 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Nuralogix Corporation,

Study Record Dates

2024-06-30