SurgeryNCT02841397
Validation of Noninvasive Hemoglobin, Comparison of PVI to Standard Methods, and Validation of Clinical Efficacy of ORI
A study testing Masimo Pulse CO-Oximeter in people with Surgery, run by Masimo Corporation at 1 site in United States.
Trial summary
The study goal is to establish the correlation of hemoglobin values determined by the noninvasive pulse oximetry-determined hemoglobin (SpHb) system with hemoglobin as measured by other validated devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Masimo Pulse CO-Oximeter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2017to 11 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Admitted into the ICU
- Aged 18 years or older
- Mechanically ventilated
- Arterial line placed
- Vigileo/Flotrac System being used for guidance of fluid management
Who cannot join
- Pregnancy
- Prisoner status
- Extreme hemodynamic instability
- Multiple vasopressors in use with questionable peripheral blood flow
- Lack of appropriate sites for sensor placement
- Patient or patient's legal representative refusal
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Medical Center
Loma Linda, California, 92354
About this study
Official title: Validation of a Pulse Oximetry Based Hemoglobin Measurement System. Comparison of Plethysmographic Variability Index to Standard Methods of Guiding Fluid and Transfusion Management in the Critically Ill Adult Patients. Validation of Clinical Efficacy of ORI for Supplemental Oxygen Titration
The study goal is to establish the correlation of hemoglobin values determined by the noninvasive pulse oximetry-determined hemoglobin (SpHb) system with hemoglobin as measured by other validated devices. The study will also evaluation oxygen reserve index (ORI) to correlate with partial pressure of oxygen (PaO2), and to evaluate pleth variability index (PVI) with stroke volume variation (SVV) or pulse pressure variation (PPV) values.
- Conditions
- Surgery
- Being tested
- Masimo Pulse CO-Oximeter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo Pulse CO-OximeterDevice
Noninvasive pulse oximeter with various features for measurement of hemoglobin, pleth variability index, and oxygen reserve index
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | All subjects will be enrolled into the test group and will receive Masimo Pulse CO-Oximeter for measurement of various physiological parameters. Receives: Device: Masimo Pulse CO-Oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Noninvasive Pulse Oximetry-determined SpHb Bias
Accuracy of SpHb will be determined by comparing it to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from SpHb value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.
Measured: Duration of study participation is up to three days.
Correlation of PVI Measurement Compared With PPV or SVV
Correlation of PVI measurement compared with pulse pressure variation PPV or stroke volume variation (SVV) measurement from arterial catheter
Measured: Duration of study participation is up to three days.
Correlation of "ORI" With Partial Pressure of Oxygen (PaO2) "PaO2" Measurement From Blood Gas Analysis
Concordance will be determined by comparing the trending ability of the Oxygen Reserve Index (ORI) measurement of the sensor with that of Partial Pressure of Oxygen in Blood (PaO2).
Measured: Duration of study participation is up to three days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study start9 Mar 2017
- Primary completion11 Oct 2017
- Study completion11 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SurgeryStudies 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
- Interventional
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masimo Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841397
- Sponsor's protocol ID
- DORO0001
- Status last verified
- Sep 2021
- First submitted
- 13 Jul 2016
- Last updated
- 21 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Pulse Oximetry Based Hemoglobin Measurement System. Comparison of Plethysmographic Variability Index to Standard Methods of Guiding Fluid and Transfusion Management in the Critically Ill Adult Patients. Validation of Clinical Efficacy of ORI for Supplemental Oxygen Titration
- ClinicalTrials.gov ID
- NCT02841397
- Acronym / sponsor ID
- DORO0001
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 11 Oct 2017 (actual)
- Study completion
- 11 Oct 2017 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Posted 21 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study goal is to establish the correlation of hemoglobin values determined by the noninvasive pulse oximetry-determined hemoglobin (SpHb) system with hemoglobin as measured by other validated devices. The study will also evaluation oxygen reserve index (ORI) to correlate with partial pressure of oxygen (PaO2), and to evaluate pleth variability index (PVI) with stroke volume variation (SVV) or pulse pressure variation (PPV) values.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Device: Masimo Pulse CO-OximeterAll subjects will be enrolled into the test group and will receive Masimo Pulse CO-Oximeter for measurement of various physiological parameters. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Admitted into the ICU
- Aged 18 years or older
- Mechanically ventilated
- Arterial line placed
- Vigileo/Flotrac System being used for guidance of fluid management
Key exclusion criteria (6 listed)
- Pregnancy
- Prisoner status
- Extreme hemodynamic instability
- Multiple vasopressors in use with questionable peripheral blood flow
- Lack of appropriate sites for sensor placement
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 Pulse CO-OximeterNoninvasive pulse oximeter with various features for measurement of hemoglobin, pleth variability index, and oxygen reserve index | Device | Test group |
Primary outcome
Noninvasive Pulse Oximetry-determined SpHb Bias
Time frame: Duration of study participation is up to three days.
Accuracy of SpHb will be determined by comparing it to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from SpHb value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.
Correlation of PVI Measurement Compared With PPV or SVV
Time frame: Duration of study participation is up to three days.
Correlation of PVI measurement compared with pulse pressure variation PPV or stroke volume variation (SVV) measurement from arterial catheter
Correlation of "ORI" With Partial Pressure of Oxygen (PaO2) "PaO2" Measurement From Blood Gas Analysis
Time frame: Duration of study participation is up to three days.
Concordance will be determined by comparing the trending ability of the Oxygen Reserve Index (ORI) measurement of the sensor with that of Partial Pressure of Oxygen in Blood (PaO2).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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?
A study testing Masimo Pulse CO-Oximeter in people with Surgery, run by Masimo Corporation 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 5 inclusion and 6 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 21 Oct 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?
Yes. Results are posted in the registry (first posted 21 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Noninvasive Pulse Oximetry-determined SpHb Bias (time frame: Duration of study participation is up to three days.). The study lists 3 primary outcomes in all. 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 21 Oct 2021.