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Oxitone Blood Validation

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Clinimark, LLC
Sponsor:
Information provided by (Responsible Party):
David Ransom, MD, Clinimark, LLC
ClinicalTrials.gov Identifier:
NCT00881829
First received: April 13, 2009
Last updated: August 10, 2016
Last verified: August 2016
  Purpose

The purpose of this study is to evaluate the SpO2 accuracy and performance of the Oxitone Medical Oxitone 1000 pulse oximeter 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 Intervention
Hypoxia
Device: Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Accuracy Validation of the Oxitone SpO2 System

Further study details as provided by Clinimark, LLC:

Primary Outcome Measures:
  • Completion of study by all subjects [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10000
Study Start Date: August 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy volunteer
Smoker or non-smoker
Device: Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature
Measurement of physiological parameters.

Detailed Description:
The purpose of this study is to evaluate the SpO2 accuracy and performance of the Oxitone Medical Oxitone 1000 pulse oximeter 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 Oxitone 1000 pulse oximeter. It is expected that the Accuracy Root Mean Square (Arms) performance of the Oxitone 1000 pulse oximeter 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
  Eligibility

Ages Eligible for Study:   18 Years to 46 Years   (Adult)
Genders Eligible for Study:   Both
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 18-46 years.

Exclusion Criteria:

  • Clotting disorders, diabetes, currently taking psychotropic medications.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881829

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

Locations
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
Principal Investigator: David Ransom, MD Avista Adventist Hospital
  More Information

Responsible Party: David Ransom, MD, Primary Investigator, Clinimark, Clinimark, LLC
ClinicalTrials.gov Identifier: NCT00881829     History of Changes
Other Study ID Numbers: PR 2016-192 Rev 1 
Study First Received: April 13, 2009
Last Updated: August 10, 2016
Health Authority: United States: Indepentant Review Board

Keywords provided by Clinimark, LLC:
Pulse Oximetry
Temperature
Respiratory Rate
Respiratory Gases
This study determine the measurement accuracy of the physiological parameters

ClinicalTrials.gov processed this record on September 27, 2016