SpO2 Hypoxia Accuracy Validation Study

Completed

• Conditions: Hypoxia
• Interventions: Other: Pulse Oximeter

• Registration Number: NCT03348189
• Lead Sponsor: Nonin Medical, Inc

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.

Study Timeline

• Status Verified: 2017-10
• Study Start: 2017-11-01
• Primary Completion: 2017-11-03
• Study Completion: 2017-11-03
• Study First Submitted: 2017-11-15
• Study First Submitted QC: 2017-11-15
• Last Update Submitted: 2017-11-15
• Study First Posted: 2017-11-20
• Last Update Posted: 2017-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Pulse Oximeter	Healthy males and females

Primary Outcome Measures

Name	Time	Method
SpO2 Hypoxia Accuracy Validation Study	Through study completion, 3 months average	Values from the test device will be compared to the values from co-oximetry to determine accuracy of the test device.

Trial Locations

Locations (1)

Clinimark; 🇺🇸 Louisville, Colorado, United States