Hypoxia Blood Validation in Multiple Pulse Oximeters
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00881829|
Recruitment Status : Recruiting
First Posted : April 15, 2009
Last Update Posted : February 26, 2021
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|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|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|
Smoker or non-smoker
Device: Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature
Measurement of physiological parameters.
- Completion of study by all subjects [ Time Frame: 5 years ]
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
|Contact: Dena M Raley, BSBE||303-249-6010||DMRaley@Clinimark.com|
|Contact: Paul B Batchelder, RRT||303-717-4820||PBatchelder@Clinimark.com|
|United States, Colorado|
|Louisville, Colorado, United States, 80027|
|Contact: Paul B Batchelder, RRT 303-717-4820 PBatchelder@Clinimark.com|
|Sub-Investigator: Paul B Batchelder, RRT, LRCP|
|Principal Investigator:||David Ransom, MD||Avista Adventist Hospital|