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CompletedNCT03592914Updated Mar 12, 2019

Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation Patients

An observational study in Respiratory Insufficiency, sponsored by Nonin Medical, Inc. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-12.

Sponsored by Nonin Medical, Inc · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study summary

Study Design: This study is a comparative, single-center study. This is a minimal risk study (as defined in 21 CFR Part 56) using a non-significant risk device (as defined in 21 CFR Part 812.3). A minimum of 60 subjects will be enrolled in the study. Subject participation will last approximately 1 hour.

Read the detailed description

Study Design: This study is a comparative, single-center study. This is a minimal risk study (as defined in 21 CFR Part 56) using a non-significant risk device (as defined in 21 CFR Part 812.3). A minimum of 60 subjects will be enrolled in the study. Subject participation will last approximately 1 hour.

Objective(s):

The primary objective of this study is to evaluate the two Fingertip Respiratory Rate (FTRR) algorithms performance of Nonin's Onyx 3 by attempting to demonstrate a mean error for FTRR \< 1.0 BPM during spontaneous breathing.

02

Conditions studied

  • Respiratory Insufficiency
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 60 is below the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Nonin Medical, Inc is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Subjects who might be seen in a respiratory rehabilitation center.

Inclusion criteria

  • The subject is at least 18 years old;
  • The subject has given written informed consent to participate in the study;
  • The subject is both willing and able to comply with study procedures.

Exclusion criteria

Exclusion Criteria:

  • The subject has a history of or current atrial fibrillation;
  • The subject has a documented history of frequent premature ventricular contractions (PVCs), defined as >3 per 30 seconds;
  • The subject has an implanted pacemaker;
  • The subject has had any relevant injury at the sensor location site (self-reported);
  • The subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination);
  • The subject is currently or trying to get pregnant (self-reported); and/or
  • The subject has another health condition which in the opinion of the principal investigator makes subject unsuitable for testing.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • subjects with respiratory disease

    This study is a comparative, single-center study. This is a minimal risk study using a non-significant risk device. A minimum of 60 and maximum of 70 subjects will be enrolled in the study. Subject participation will last approximately 1 hour(s).

06

What researchers measure

Primary outcomes

  1. Evaluate the two Fingertip Respiratory Rate (FTRR) algorithms performance of Nonin's Onyx 3

    Measure respiratory rates

    Time frame: 40 minutes

07

Study locations

1 site
  • Nonin Medical, Inc.
    Plymouth, Minnesota 55441, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03592914
Lead sponsor
Nonin Medical, Inc
Collaborators
Valley Inspired Products
Responsible party
Sponsor
First posted
Jul 19, 2018
Start date
Jul 31, 2018
Primary completion
Jan 16, 2019
Completion
Jan 16, 2019
Last update
Mar 12, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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