Accuracy of Pulse CO-Oximetry Technology in Characterizing Noninvasive SpHb
|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: NCT01997502|
Recruitment Status : Recruiting
First Posted : November 28, 2013
Last Update Posted : June 11, 2020
|Condition or disease||Intervention/treatment|
|Surgery Hemoglobin||Device: Pulse CO-Oximetry Technology Other: Blood draw|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Prospective Observational Study Characterizing Noninvasive Hemoglobin (SpHb) Measured With Pulse CO-Oximetry Technology in a Variety of Surgical Cases|
|Actual Study Start Date :||November 26, 2013|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
- Device: Pulse CO-Oximetry Technology
In addition to the standard pulse oximeter used for clinical care, up to six SpHb finger sensors will be applied to the patient. Additional sensors may also be applied to the forehead, neck, chest and ears.
Masimo FDA cleared pulse CO-Oximeter devices: Radical-7, Rad-87, Rad-57, Pronto, Pronto-7, for the noninvasive measurement of SpO2, PR, PI, PVI, SpCO, SpMet, and SpHb, total hemoglobin and respiratory rate.
No treatment decisions will be made based on the new technology and no extra medical procedures are required for the study.
- Other: Blood draw
4mL arterial blood samples (up to 1 per hour), outside standard of care, are drawn throughout the surgical procedure and sent to UCDMC lab/Masimo lab for analysis.
- Comparison of Masimo Rainbow technology to arterial blood samples taken during surgery [ Time Frame: Five year ]Correlation between standard, lab-based, hemoglobin measurement and concurrent SpHb.
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): NCT01997502
|Contact: Neal W Fleming, M.D., Ph.D.||firstname.lastname@example.org|
|Contact: Ana Arias, BSemail@example.com|
|United States, California|
|UC Davis Health||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Neal W Fleming, M.D., Ph.D. 916-734-5394 firstname.lastname@example.org|
|Contact: Ana Arias, BS 916-703-5456 email@example.com|
|Principal Investigator: Neal W Fleming, MD, PhD|
|Principal Investigator:||Neal Fleming, M.D., Ph.D.||Professor, Director, Cardiovascular and Thoracic Anesthesiology|