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

Hypoxia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02475668
• Other study ID #: QATP2759
• Status: Completed
• Phase: N/A
• First received: June 16, 2015
• Last updated: July 9, 2015
• Start date: June 2015
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Nonin Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 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 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypoxia

Intervention

Device:
• Pulse oximeter
Hypoxia

Locations

Country	Name	City	State
United States	Clinimark	Louisville	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Nonin Medical, Inc	Clinimark, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accuracy value (Arms) for %SpO2 over the range of 70-100% in motion and non-motion		3 days	No