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CompletedNCT02475668Updated Jul 10, 2015

SpO2 Accuracy Validation of Pulse Oximetry Systems During Motion and Non-Motion Conditions

An observational study in Hypoxia, sponsored by Nonin Medical, Inc. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-10.

Sponsored by Nonin Medical, Inc · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
13
Ages
18 Years to 45 Years
Sex
All
01

Study summary

Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry systems.

Read the detailed description

Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry systems during motion and non-motion.

02

Conditions studied

  • Hypoxia

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03

In context

Hypoxia

1,231 studies on the registry are indexed under Hypoxia; 242 are open to participants now.

This study's enrollment of 13 is below the median of 67 across 335 observational studies indexed under Hypoxia.

Browse Hypoxia 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 to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy volunteers

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 (self-reported)
  • The subject has at least one finger height of 0.2 - 1.0 inch (based on measurement)
  • The subject is between 18 years and 45 years of age (self=reported)
  • The subject shows no evidence of medical problems as indicated by satisfactory completion of the health assessment form
  • 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 31 (based on weight and height)
  • 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 current smoker (self-reported)
  • 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 has a clotting disorder (self-reported)
  • The subject has Raynaud's Disease (self-reported)
  • The subject is known to have a hemoglobinopathy (self-reported)
  • The subject is on blood thinners or medication with aspirin (self-reported)
  • The subject has unacceptable collateral circulation from the ulnar artery (based on examination)
  • The subject is unwilling or unable to provide written informed consent to participate in the study
  • The subject is unwilling or unable to comply with the study procedures
  • 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
Cohort
Time perspective
Prospective
Enrollment
13 participants (actual)
Patient registry
No

Interventions

  • DevicePulse oximeter

    Hypoxia

06

What researchers measure

Primary outcomes

  1. accuracy value (Arms) for %SpO2 over the range of 70-100% in motion and non-motion

    Time frame: 3 days

07

Study locations

1 site
  • Clinimark
    Louisville, Colorado 80027, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02475668
Lead sponsor
Nonin Medical, Inc
Collaborators
Clinimark, LLC
Responsible party
Sponsor
First posted
Jun 19, 2015
Start date
Jun 2015
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Jul 10, 2015

Study contacts

Dave Ransom, MD
principal investigator · Avista Adventis Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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