Patients Undergoing Spine SurgeryNCT01877876
Assessing the Accuracy of the RevK Sensor
An observational study of Patients Undergoing Spine Surgery, run by University of California, San Francisco at 1 site in United States.
Trial summary
Evaluation of a new generation of sensors for monitoring blood hemoglobin. The newest version is RevK. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Patients Undergoing Spine Surgery
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jun 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing spine surgery
Who may be able to join
- Male or non-pregnant female
- American Society of Anesthesiology Classification 1, 2 or 3
- Scheduled to undergo spine or hip surgery
Who cannot join
- Pregnant or nursing
- Patients who in the study investigators clinical judgement would not be suitable for research
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Assessing the Accuracy of the RevK Sensor for Non-Invasive Hemoglobin Monitoring
Evaluation of a new generation of sensors for monitoring blood hemoglobin. The newest version is RevK.
Read the detailed description
Evaluation of a new generation of sensors for monitoring blood hemoglobin with the Masimo non-invasive hemoglobin monitor. The newest sensor version is RevK.
- Conditions
- Patients Undergoing Spine Surgery
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 |
|---|---|---|
| Patient undergoing spine surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the accuracy of the RevK sensor for measuring blood hemoglobin compared to a laboratory-derived hemoglobin value.
Primary outcome is based on the difference between a value from the SpHb (Masimo SpHb™ continuous hemoglobin reading) minus tHb (laboratory hemoglobin determination).
Measured: Intermittently during spine surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Spine SurgeryStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald D Miller, MD, MS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877876
- Sponsor's protocol ID
- 10-00524E
- Status last verified
- Jun 2015
- First submitted
- 28 May 2013
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Accuracy of the RevK Sensor for Non-Invasive Hemoglobin Monitoring
- ClinicalTrials.gov ID
- NCT01877876
- Acronym / sponsor ID
- 10-00524E
- Conditions
- Patients Undergoing Spine Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 14 Jun 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.
Evaluation of a new generation of sensors for monitoring blood hemoglobin. The newest version is RevK.
Detailed description
Evaluation of a new generation of sensors for monitoring blood hemoglobin with the Masimo non-invasive hemoglobin monitor. The newest sensor version is RevK.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient undergoing spine surgery | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing spine surgery
Key inclusion criteria (3 listed)
- Male or non-pregnant female
- American Society of Anesthesiology Classification 1, 2 or 3
- Scheduled to undergo spine or hip surgery
Key exclusion criteria (2 listed)
- Pregnant or nursing
- Patients who in the study investigators clinical judgement would not be suitable for research
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
To assess the accuracy of the RevK sensor for measuring blood hemoglobin compared to a laboratory-derived hemoglobin value.
Time frame: Intermittently during spine surgery
Primary outcome is based on the difference between a value from the SpHb (Masimo SpHb™ continuous hemoglobin reading) minus tHb (laboratory hemoglobin determination).
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 10 Jun 2015.
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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.
Ronald D Miller, MD, MS principal investigator
University of California, San Francisco
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 Patients Undergoing Spine Surgery, run by University of California, San Francisco 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 3 inclusion and 2 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 10 Jun 2015. 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?
To assess the accuracy of the RevK sensor for measuring blood hemoglobin compared to a laboratory-derived hemoglobin value. (time frame: Intermittently during spine surgery). 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 10 Jun 2015.