SurgeryNCT01997502
Accuracy of Pulse CO-Oximetry Technology in Characterizing Noninvasive SpHb
An observational study of Surgery and Hemoglobin, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Hemoglobin
- What is being tested?
- Pulse CO-Oximetry Technology and Blood draw
- Type of treatment
- Medical device
- How many people
- 621 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2013to 21 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective surgery.
Who may be able to join
- Patients scheduled for elective surgery requiring intra-arterial pressure monitoring
Who cannot join
- Age less than 18 years
- Pregnancy
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Study Characterizing Noninvasive Hemoglobin (SpHb) Measured With Pulse CO-Oximetry Technology in a Variety of Surgical Cases
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.
Read the 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
- Surgery, Hemoglobin
- Being tested
- Pulse CO-Oximetry Technology, Blood draw
- Keywords
- Hemoglobin, Non-invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse CO-Oximetry TechnologyDevice
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.
Blood drawOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Masimo Rainbow technology to arterial blood samples taken during surgery
Correlation between standard, lab-based, hemoglobin measurement and concurrent SpHb.
Measured: Five year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study start26 Nov 2013
- Primary completion21 Oct 2024
- Study completion21 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 621 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neal Fleming, M.D., Ph.D., Principal investigator, Professor, Director, Cardiovascular and Thoracic Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997502
- Sponsor's protocol ID
- 494171
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2013
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study Characterizing Noninvasive Hemoglobin (SpHb) Measured With Pulse CO-Oximetry Technology in a Variety of Surgical Cases
- ClinicalTrials.gov ID
- NCT01997502
- Acronym / sponsor ID
- 494171
- Conditions
- Surgery, Hemoglobin
- Keywords
- Hemoglobin, Non-invasive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 621 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 26 Nov 2013 (actual)
- Primary completion
- 21 Oct 2024 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective surgery.
Key inclusion criteria (1 listed)
- Patients scheduled for elective surgery requiring intra-arterial pressure monitoring
Key exclusion criteria (3 listed)
- Age less than 18 years
- Pregnancy
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse CO-Oximetry TechnologyIn 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. | Device | – |
| Blood draw4mL 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. | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Learn more or sign up for the study here!Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neal Fleming, M.D., Ph.D. principal investigator
Professor, Director, Cardiovascular and Thoracic Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Hemoglobin, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Masimo Rainbow technology to arterial blood samples taken during surgery (time frame: Five year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.