Expired Study
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Louisville, Colorado 80027


Purpose:

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


Study summary:

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


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.


Study is Available At:


Original ID:

QATP2759


NCT ID:

NCT02475668


Secondary ID:


Study Acronym:


Brief Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Nonin Medical, Inc


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: Pro


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

13


Enrollment Type:

Actual


Overall Contact Information

Official Name:Dave Ransom, MD
Principal Investigator
Avista Adventis Hospital

Study Dates

Start Date:June 2015
Completion Date:June 2015
Completion Type:Actual
Primary Completion Date:June 2015
Primary Completion Type:Actual
Verification Date:July 2015
Last Changed Date:July 9, 2015
First Received Date:June 16, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:accuracy value (Arms) for %SpO2 over the range of 70-100% in motion and non-motion
Time Frame:3 days
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Pulse oximeter
Description:Hypoxia

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Nonin Medical, Inc
Agency Class:Other
Agency Type:Collaborator
Agency Name:Clinimark, LLC

Samples and Retentions

Study Population: Healthy volunteers
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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