Clinical trial NCT02475668: SpO2 Accuracy Validation of Pulse Oximetry Systems During Motion and Non-Motion Conditions
Official title: SpO2 Accuracy Validation of Pulse Oximetry Systems During Motion and Non-Motion Conditions of Induced Hypoxia as Compared to Arterial Blood CO-Oximetry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxia
Lead sponsor: Nonin Medical, Inc
Sponsor class: INDUSTRY
Collaborators: name: Clinimark, LLC
First posted: 2015-06-19
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

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

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

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: accuracy value (Arms) for %SpO2 over the range of 70-100% in motion and non-motion
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Clinimark
state: Colorado
Study officials:
affiliation: Avista Adventis Hospital
name: Dave Ransom, MD
role: PRINCIPAL_INVESTIGATOR
References: