Clinical trial NCT03348189: SpO2 Hypoxia Accuracy Validation Study
Official title: SpO2 Hypoxia Accuracy Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxia
Lead sponsor: Nonin Medical, Inc
Sponsor class: INDUSTRY
First posted: 2017-11-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A minimum of 12 subjects will be enrolled. The subject population will include both male and female subjects with a variety of skin tones.

Brief summary: The primary objective of this study is to evaluate the % oxygen saturation by pulse oximetry accuracy of a combined pulse oximetry system which consists of a Nonin sensor ), an adaptor cable, and an oximetry system during non-motion conditions.

Detailed description: The primary objective of this study is to evaluate the %SpO2 accuracy of a combined pulse oximetry system which consists of a Nonin sensor ), an adaptor cable, and an oximetry system during non-motion conditions.

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 50 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, is actively trying to get pregnant, or who has a positive urine pregnancy test on the day of the study
* 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: SpO2 Hypoxia Accuracy Validation Study
timeFrame: Through study completion, 3 months average
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Clinimark
state: Colorado
Study officials:
affiliation: Clinimark, LLC
name: Dena Raley
role: STUDY_DIRECTOR
References: