Hypoxia Blood Validation in Multiple Pulse Oximeters

NCT ID: NCT00881829

Last Updated: 2021-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-09

Study Completion Date

2021-12-21

Brief Summary

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The purpose of this study is to evaluate the SpO2 accuracy and performance of multiple pulse oximeters during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation.

This study is observational in nature which quantifies device performance and accuracy in comparison to a Reference Standard.

Detailed Description

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The purpose of this study is to evaluate the SpO2 accuracy and performance of pulse oximeters during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation. The end goal is to show the SpO2 accuracy performance of the pulse oximeters. It is expected that the Accuracy Root Mean Square (Arms) performance of pulse oximeters will meet a specification of 3 or better in non-motion conditions for the range of 70-100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification

Conditions

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Hypoxia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy volunteer

Smoker or non-smoker

Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature

Intervention Type DEVICE

Measurement of physiological parameters.

Interventions

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Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature

Measurement of physiological parameters.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* healthy individuals between the age of 18-50 years.

Exclusion Criteria

* Clotting disorders, diabetes, currently taking psychotropic medications.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Clinimark, LLC

OTHER

Sponsor Role lead

Responsible Party

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David Ransom, MD

Primary Investigator, Clinimark

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Ransom, MD

Role: PRINCIPAL_INVESTIGATOR

Avista Adventist Hospital

Locations

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Clinimark Laboratories

Louisville, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dena M Raley, BSBE

Role: CONTACT

303-249-6010

Paul B Batchelder, RRT

Role: CONTACT

303-717-4820

Facility Contacts

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Paul B Batchelder, RRT

Role: primary

303-717-4820

Other Identifiers

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PR 2016-192 Rev 1

Identifier Type: -

Identifier Source: org_study_id

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