Adult Patient Undergoing Major SurgeryNCT00762398
Evaluation of the Accuracy and Precision of the Masimo Labs Pulse-Hemoglobin-Meter Monitor in Surgical Patients
An observational study of Adult Patient Undergoing Major Surgery, run by University of California, Irvine at 1 site in United States.
Trial summary
The Masimo monitor can measure hemoglobin level noninvasively and accuratly Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Patient Undergoing Major Surgery
- What is being tested?
- Masimo hemoglobin-meter and drawing blood sample
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Dec 2011
- 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: Adult patients in UCI Medical Center undergoing surgery
Who may be able to join
- Adult having surgery with arterial line
Who cannot join
- Upper extremities surgery
- Pregnant women
- Children
Trial locations and contacts
1 site in 1 country.
United States1 site
Univeristy of California Irvine Medical Center
Orange, California, 92868
About this study
The Masimo monitor can measure hemoglobin level noninvasively and accuratly
Read the detailed description
Blood hemoglobin concentration is a very common and essential test to assess patient well being and the need for blood transfusion. In the perioperative period this measurement is further more critical mainly due to the acute nature of blood loss and the need for an immediate response. Currently, hemoglobin concentration is determined by analyzing a blood sample. It requires venipuncture or arterial puncture (via an arterial line). Besides the patient discomfort there are additional disadvantages such as infection, dealing with blood product, delay with diagnosis, low update rate and cost. Masimo Labs is in the process of developing a noninvasive monitor to detect hemoglobin concentrations in real time. The monitor uses a probe placed on the patient finger that gives hemoglobin concentration continuously and noninvasively. Masimo Labs is using a technology that resembles the well accepted and clinically proven pulse-oxymeter.
The study will include surgical patients at the UCI Medical Center, preferably in cases that are known to involve major blood loss. For these cases, the anesthesia team places an arterial line for anesthesia purposes. The arterial line is used for continuous blood pressure measurements and blood draw for the assessment of several indices. We plan to compare the hemoglobin concentrations measured from blood samples to the Masimo Labs pulse-hemoglobin level readings.
- Conditions
- Adult Patient Undergoing Major Surgery
- Being tested
- Masimo hemoglobin-meter, drawing blood sample
- Keywords
- Major surgery, excpected blood loss, arterial line
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo hemoglobin-meterDevice
Placing a probe on the finger
drawing blood sampleBiological
drawing a blood sample less that 0.5 mL each time, for around 10-12 times along the surgery (depends on surgical time)
| Study group | Role | What they receive |
|---|---|---|
| Adult patient undergoing a surgery | Adult patient undergoing a surgery in the supine position and require an arterial line for anesthesia/surgery purposes Receives: Device: Masimo hemoglobin-meter; Biological: drawing blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
corrlation of up to +/-0.1 gr% of the blood analysis to the monitor reading
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2008
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Patient Undergoing Major SurgeryStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Masimo Labs
- Responsible party
- Sponsor
- Investigators
- Abraham Rosenbaum, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762398
- Sponsor's protocol ID
- 2008-6221
- Status last verified
- Mar 2021
- First submitted
- 26 Sep 2008
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy and Precision of the Masimo Labs Pulse-Hemoglobin-Meter Monitor in Surgical Patients
- ClinicalTrials.gov ID
- NCT00762398
- Acronym / sponsor ID
- 2008-6221
- Conditions
- Adult Patient Undergoing Major Surgery
- Keywords
- Major surgery, excpected blood loss, arterial line
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Masimo Labs
- Study start
- Sep 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Sep 2008 (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.
The Masimo monitor can measure hemoglobin level noninvasively and accuratly
Detailed description
Blood hemoglobin concentration is a very common and essential test to assess patient well being and the need for blood transfusion. In the perioperative period this measurement is further more critical mainly due to the acute nature of blood loss and the need for an immediate response. Currently, hemoglobin concentration is determined by analyzing a blood sample. It requires venipuncture or arterial puncture (via an arterial line). Besides the patient discomfort there are additional disadvantages such as infection, dealing with blood product, delay with diagnosis, low update rate and cost. Masimo Labs is in the process of developing a noninvasive monitor to detect hemoglobin concentrations in real time. The monitor uses a probe placed on the patient finger that gives hemoglobin concentration continuously and noninvasively. Masimo Labs is using a technology that resembles the well accepted and clinically proven pulse-oxymeter.
The study will include surgical patients at the UCI Medical Center, preferably in cases that are known to involve major blood loss. For these cases, the anesthesia team places an arterial line for anesthesia purposes. The arterial line is used for continuous blood pressure measurements and blood draw for the assessment of several indices. We plan to compare the hemoglobin concentrations measured from blood samples to the Masimo Labs pulse-hemoglobin level readings.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patient undergoing a surgery | – | Device: Masimo hemoglobin-meter, Biological: drawing blood sampleAdult patient undergoing a surgery in the supine position and require an arterial line for anesthesia/surgery purposes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients in UCI Medical Center undergoing surgery
Key inclusion criteria (1 listed)
- Adult having surgery with arterial line
Key exclusion criteria (3 listed)
- Upper extremities surgery
- Pregnant women
- Children
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 |
|---|---|---|
| Masimo hemoglobin-meterPlacing a probe on the finger | Device | Adult patient undergoing a surgery |
| drawing blood sampledrawing a blood sample less that 0.5 mL each time, for around 10-12 times along the surgery (depends on surgical time) | Biological | Adult patient undergoing a surgery |
Primary outcome
corrlation of up to +/-0.1 gr% of the blood analysis to the monitor reading
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
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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.
Abraham Rosenbaum, MD principal investigator
University of California, Irvine
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 Adult Patient Undergoing Major Surgery, run by University of California, Irvine 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: stopped early, as of the sponsor's last update on 29 Mar 2021. 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 was stopped early. Results are not available in the source record.
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?
corrlation of up to +/-0.1 gr% of the blood analysis to the monitor reading (time frame: 1 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 29 Mar 2021.