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CompletedNCT03223870Updated Aug 2, 2017

Respiratory Rate Accuracy - Healthy Adults

An observational study in Normal Respiration Patterns, sponsored by Nonin Medical, Inc. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-02.

Sponsored by Nonin Medical, Inc · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The objective of this study is to evaluate the Fingertip Respiratory Rate algorithm performance of the Nonin Medical X-100SP pulse oximetry systems with the 8300AA sensors and Onyx 3 fingertip oximeter. There is no treatment or interventions being performed.

Read the detailed description
  1. Start data collection system(s) and allow them to run 15 minutes prior to study start of each subject.
  2. Confirm that the subject meets inclusion/exclusion criteria and has signed the current IRB- approved Informed Consent Form
  3. Collect Demographic and Anthropometric Data from the subject.
  4. Place Pulse Oximetry Sensors
  5. Place nasal cannula for capnography recordings

  6. A summary of Respiratory rate protocol.

    1. Stage 1: Subject will rest quietly and breathe at a normal comfortable rate for 40 minutes. The start and stop times will be marked on the data collection system.
    2. Stage 2: Immediately after Stage 1 is complete, the subject will start the 25 minute paced breathing protocol which will ramp from 5-45 BPM. A computer program will be used to guide the subject through the stage 2 paced breathing. The start and stop times will be marked on the data collection system.
02

Conditions studied

  • Normal Respiration Patterns
03

In context

Lead sponsor

Nonin Medical, Inc is the lead sponsor of 19 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 to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

A minimum of 30 subjects will be included in this study. The subject selection will be an approximately equal mix of males and females with varying skin tones. At a rate of 3-4 subjects per day, enrollment will take approximately 7-10 days to complete.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The subject is male or female
  • The subject is of any racial or ethnic group
  • The subject is > 30 kg (>66 pounds) in weight (based on measurement)
  • The subject has at least one finger with a height of 0.3 - 1.0 inch (7.6 -25.4 mm) (based on measurement)
  • The subject is between 18 years and 50 years of age (self-reported)
  • 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 BMI greater than 30 (based on weight and height)
  • The subject has a history of atrial fibrillation (self-reported)
  • The subject has a documented history of frequent premature ventricular contractions (PVCs), defined as >3 per 30 seconds (self-reported)
  • The subject has an implanted pacemaker (self-reported)
  • 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 has a known respiratory condition (self-reported)
  • The subject has a known heart or cardiovascular condition (self-reported)
  • The subject is currently pregnant (self-reported)
  • The subject is actively trying to get pregnant (self-reported)
  • The subject is unwilling or unable to provide written informed consent to participate in the study
  • The subject has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • Oximeters

    Comparison of respiratory rates with other devices in normal subjects as observational with other pulse oximeters. No treatment of interventions will be performed.

    Diagnostic Test: Diagnostic

Interventions

  • Diagnostic testDiagnostic

    Diagnostic

06

What researchers measure

Primary outcomes

  1. Respiratory Rate Accuracy

    Values from the test device will be compared to the values from co-oximetry devices

    Time frame: 3 months

07

Study locations

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03223870
Lead sponsor
Nonin Medical, Inc
Responsible party
Sponsor
First posted
Jul 21, 2017
Start date
Jul 11, 2017
Primary completion
Jul 31, 2017
Completion
Jul 31, 2017
Last update
Aug 2, 2017

Study contacts

Walter Holbein, Ph.D
principal investigator · Nonin Medical, Inc

Oversight

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

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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