Accuracy of Pulse CO-Oximetry Technology in Characterizing Noninvasive SpHb
Sponsor
University of California, Davis (Other)
Overall Status
Recruiting
CT.gov ID
NCT01997502
Collaborator
(none)
300
1
120.1
2.5
Study Details
Study Description
Brief Summary
This protocol is a request from Masimo to assist in the collection of data to be used to further refine the accuracy of the monitor's algorithm.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The specific aim of this study is to collect data to characterize Masimo's noninvasive Rainbow SpHb technology during surgeries. The purpose is to compare Masimo Rainbow technology to arterial blood samples taken during surgery. Hemoglobin concentrations in the arterial blood samples will be measured using standard blood analyzers on site and/or the sponsor's laboratory.
Study Design
Study Type:
Observational
Anticipated Enrollment
:
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
:
Nov 26, 2013
Anticipated Primary Completion Date
:
Dec 1, 2022
Anticipated Study Completion Date
:
Dec 1, 2023
Outcome Measures
Primary Outcome Measures
- Comparison of Masimo Rainbow technology to arterial blood samples taken during surgery [Five year]
Correlation between standard, lab-based, hemoglobin measurement and concurrent SpHb.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients scheduled for elective surgery requiring intra-arterial pressure monitoring
Exclusion Criteria:
-
Age less than 18 years
-
Pregnancy
-
Prisoners
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UC Davis Health | Sacramento | California | United States | 95817 |
Sponsors and Collaborators
- University of California, Davis
Investigators
- Principal Investigator: Neal Fleming, M.D., Ph.D., Professor, Director, Cardiovascular and Thoracic Anesthesiology
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01997502
Other Study ID Numbers:
- 494171
First Posted:
Nov 28, 2013
Last Update Posted:
Jan 28, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by University of California, Davis