AnemiaNCT01811342
Continuous Hemoglobin Evaluation
An observational study of Anemia, run by University of California, Davis at 1 site in United States.
Trial summary
Evaluate potential sources of error that affect the accuracy of continuous hemoglobin monitoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Sep 2015
- 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 undergoing elective surgery.
Who may be able to join
- Patients undergoing elective surgery.
Who cannot join
- 0
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
Official title: Evaluation of the Masimo Continuous Hemoglobin Monitor With Polar Plot Methodology
Evaluate potential sources of error that affect the accuracy of continuous hemoglobin monitoring.
- Conditions
- Anemia
- Keywords
- Hemoglobin, Patient Monitoring
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hemoglobin Measurement | Patients requiring intra-operative hemoglobin measurement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the Masimo Continuous Hemoglobin Monitor with Polar Plot Methodology
Determine the influence of initial calibration and intraoperative oxygenation variables on the correlation between SpHgb and clinical values
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startNov 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811342
- Sponsor's protocol ID
- 348788
- Status last verified
- Feb 2018
- First submitted
- 7 Mar 2013
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Masimo Continuous Hemoglobin Monitor With Polar Plot Methodology
- ClinicalTrials.gov ID
- NCT01811342
- Acronym / sponsor ID
- 348788
- Conditions
- Anemia
- Keywords
- Hemoglobin, Patient Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 14 Mar 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.
Evaluate potential sources of error that affect the accuracy of continuous hemoglobin monitoring.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemoglobin Measurement | – | –Patients requiring intra-operative hemoglobin measurement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective surgery.
Key inclusion criteria (1 listed)
- Patients undergoing elective surgery.
Key exclusion criteria (1 listed)
- 0
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the Masimo Continuous Hemoglobin Monitor with Polar Plot Methodology
Time frame: One year
Determine the influence of initial calibration and intraoperative oxygenation variables on the correlation between SpHgb and clinical values
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 27 Feb 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anemia, 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 1 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 27 Feb 2018. 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?
Evaluation of the Masimo Continuous Hemoglobin Monitor with Polar Plot Methodology (time frame: One 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 27 Feb 2018; AzTrials last refreshed its copy on 31 Oct 2026.