SpO2 Hypoxia Accuracy Validation Study

Hypoxia Clinical Trial

Official title:

SpO2 Hypoxia Accuracy Validation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03348189
• Other study ID #: QATP3093
• Status: Completed
• Phase: N/A
• First received: November 15, 2017
• Last updated: November 15, 2017
• Start date: November 1, 2017
• Est. completion date: November 3, 2017

Study information

• Verified date: October 2017
• Source: Nonin Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 3, 2017
• Est. primary completion date: November 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypoxia

Intervention

Other:
• Pulse Oximeter
Pulse Oximeter

Locations

Country	Name	City	State
United States	Clinimark	Louisville	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Nonin Medical, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SpO2 Hypoxia Accuracy Validation Study	Values from the test device will be compared to the values from co-oximetry to determine accuracy of the test device.	Through study completion, 3 months average