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Hypoxia Blood Validation in Multiple Pulse Oximeters

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ClinicalTrials.gov Identifier: NCT00881829
Recruitment Status : Recruiting
First Posted : April 15, 2009
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
David Ransom, MD, Clinimark, LLC

Brief Summary:

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.


Condition or disease Intervention/treatment
Hypoxia Device: Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature

Detailed Description:
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

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Accuracy Validation in Multiple SpO2 Systems
Actual Study Start Date : August 9, 2016
Estimated Primary Completion Date : December 21, 2021
Estimated Study Completion Date : December 21, 2021

Group/Cohort Intervention/treatment
Healthy volunteer
Smoker or non-smoker
Device: Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature
Measurement of physiological parameters.




Primary Outcome Measures :
  1. Completion of study by all subjects [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Residents of the Denver metropolitan area.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Clotting disorders, diabetes, currently taking psychotropic medications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00881829


Contacts
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Contact: Dena M Raley, BSBE 303-249-6010 DMRaley@Clinimark.com
Contact: Paul B Batchelder, RRT 303-717-4820 PBatchelder@Clinimark.com

Locations
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United States, Colorado
Clinimark Laboratories Recruiting
Louisville, Colorado, United States, 80027
Contact: Paul B Batchelder, RRT    303-717-4820    PBatchelder@Clinimark.com   
Sub-Investigator: Paul B Batchelder, RRT, LRCP         
Sponsors and Collaborators
Clinimark, LLC
Investigators
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Principal Investigator: David Ransom, MD Avista Adventist Hospital
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Responsible Party: David Ransom, MD, Primary Investigator, Clinimark, Clinimark, LLC
ClinicalTrials.gov Identifier: NCT00881829    
Other Study ID Numbers: PR 2016-192 Rev 1
First Posted: April 15, 2009    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021
Keywords provided by David Ransom, MD, Clinimark, LLC:
Pulse Oximetry
Temperature
Respiratory Rate
Respiratory Gases
This study determine the measurement accuracy of the physiological parameters
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory