Trials / Completed
CompletedNCT01997502
Accuracy of Pulse CO-Oximetry Technology in Characterizing Noninvasive SpHb
Prospective Observational Study Characterizing Noninvasive Hemoglobin (SpHb) Measured With Pulse CO-Oximetry Technology in a Variety of Surgical Cases
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 621 (actual)
- Sponsor
- University of California, Davis · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2013-11-26
- Primary completion
- 2024-10-21
- Completion
- 2024-10-21
- First posted
- 2013-11-28
- Last updated
- 2025-04-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01997502. Inclusion in this directory is not an endorsement.