NCT02870179

Brief Summary

The purpose of this study is to conduct a SpO2 hypoxia evaluation of the Oxitone Medical Oxitone 1000 pulse oximeter. The Oxitone 1000 pulse oximeter will be evaluated during non-motion conditions over the range of 70-100% SpO2 in comparison to a Reference Pulse Oximeter. The study is observational in nature which quantifies device performance and accuracy in compassion to a Reference Pulse Oximeter.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

1 month

First QC Date

August 10, 2016

Last Update Submit

April 19, 2017

Conditions

Hypoxia

Keywords

Pulse OximetryTemperatureRespiratory RateRespiratory GasesThis study determines the measurement accuracy of the physiological parameters

Outcome Measures

Primary Outcomes (2)

  • Collect SpO2 data for accuracy statistical analysis by 12 subjects

    Data is collected in a digital form for 4-6 SpO2 stable plateaus in a specified range from 100% to 70%.

    2 months

  • Accuracy data analysis

    Bland-Altman graphical plots. An Accuracy Root Mean Square (ARMS) calculation is used as a means to define the SpO2 accuracy. Data analysis will follow ISO80601-2-61, Annex EE and the FDA Guidance Document for Pulse Oximeters (Martch 4, 2013).

    2 months

Secondary Outcomes (1)

  • Error plots

    2 months

Study Arms (1)

Healthy volunteer

Smoker or non-smoker

Device: Pulse Oximeter

Interventions

Pulse OximeterDEVICE

Measurement of physiological parameters

Also known as: Blood Pressure, Respiratory Rate, Respiratory Gassess, Temperature
Healthy volunteer

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Residents of the Denver metropolitan area

You may qualify if:

  • Healthy individuals between the age of 18-50

You may not qualify if:

  • Clotting disorders, diabetes, currently taking psychotropic medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinimark Laboratories

Louisville, Colorado, 80027, United States

Location

MeSH Terms

Conditions

Hypoxia

Interventions

Blood PressureRespiratory RateBody Temperature

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaRespirationRespiratory Physiological PhenomenaPhysiological Phenomena

Study Officials

  • Leon Eisen, PhD

    Oxitone Medical Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Leon Eisen, CEO

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 17, 2016

Study Start

August 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

April 20, 2017

Record last verified: 2017-04

Locations

US(1)