Sphb Haemoglobin in Vivo ValidationNCT02399488
Validation of Continuous Noninvasive Haemoglobin Monitoring by the Radical 7 Pulse CO-Oximetry Monitor After in Vivo Adjustment.
An observational study of Sphb Haemoglobin in Vivo Validation, run by Hospital Universitario Doctor Peset at 1 site in Spain.
Trial summary
Continuous haemoglobin determination could improve the outcomes of several patients in risk of bleeding during surgery. An in vivo calibration has been introduced to the device after our team found its need. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sphb Haemoglobin in Vivo Validation
- What is being tested?
- Masimo Radical 7
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Feb 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: Adult patients scheduled to any surgery of at least three hours of duration.
Who may be able to join
- Adult patients.
- Surgery duration of at least two hours.
- Patients scheduled to surgery under general anaesthesia and muscle relaxation.
- Radial arterial line needed for blood pressure control or other reason not related to the study.
Who cannot join
- Radial arterial line not indicated / not possible to place.
- Sampling difficult or impossible.
- Need to reposition arterial line arm during surgery.
- Any illness that could influence the haemoglobin measurement.
Trial locations and contacts
1 site in 1 country.
Juan Soliveres, MD, PhD contact
Spain1 site, 1 recruiting
- Recruiting
University Hospital Doctor Peset
Valencia, 46023
Juan Soliveres, MD, PhD
About this study
Official title: Validation of a Continuous Noninvasive Haemoglobin Determination Monitor (Radical 7 Pulse CO-Oximeter, SpHb) Compared to the Central Laboratory Coulter (LabHb) and a Point of Care (POC) Invasive Cooximeter (COoxHb) After in Vivo Adjustment.
Continuous haemoglobin determination could improve the outcomes of several patients in risk of bleeding during surgery. An in vivo calibration has been introduced to the device after our team found its need. The uncalilbrated validation of the Masimo Radical 7 continuous haemoglobin monitor has been made in various papers, although it has been compared to point of care devices, thus introducing an error as such point of care devices although validated for haemoglobin determination, are not as accurate as the gold standard. The validation of the gold standard calibrated device has not been described yet.
When compared to the accepted gold standard (cyanmethemoglobin method, Coulter), accuracy and precision of the continuous haemoglobin monitor could be good enough to be used interchangeably with the gold standard.
Read the detailed description
Continuous haemoglobin determination could improve the outcomes of several patients in risk of bleeding during surgery.
The in vivo calibration has not been adjusted to the gold standard haemoglobin determination in the literature yet.
Two blood samples will be withdrawn at the same time from an arterial line, one for the central laboratory and the other one for the POC device. At the same exact time the SpHb measurement will be recorded. At least eight samples are expected per patient. A maximum of 20 samples will be withdrawn per patient.
To compare bias, precision and limits of agreement among SpHb, LabHb and COoxHb the Bland Altman method will be used with multiple observations per subject when the true value varies. An error grid analysis will be made to know how it could affect to clinical decision making.
- Conditions
- Sphb Haemoglobin in Vivo Validation
- Being tested
- Masimo Radical 7
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo Radical 7Device
Simultaneous determination of haemoglobin with the continuous haemoglobin monitor, the central lanboratory coulter and a POC:
What is being measured
The primary outcome is the main question the study is designed to answer.
Central coulter bias and limits of agreement
Bias and limits of agreement of SpHb compared to the central laboratory coulter
Measured: 3 months
Central coulter bias and limits of agreement after in vivo calibration
Bias and limits of agreement of SpHb compared to the central laboratory coulter after in vivo Radical 7 calibration
Measured: 3 months
Secondary outcomes (3)
POC Cooximeter bias and limits of agreement
Bias and limits of agreement of SpHb compared to the POC cooximeter
Measured: 3 months
POC Cooximeter bias and limits of agreement
Bias and limits of agreement compared to the POC cooximeter after in vivo Radical 7 calibration
Measured: 3 months
POC Cooximeter Coulter interchangeability
Bias and limits of agreement of POC Cooximeter Hb determination compared to the central laboratory coulter
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startFeb 2012
- Primary completionJun 2015
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sphb Haemoglobin in Vivo ValidationStudies 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Doctor Peset
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Soliveres, Hospital Universitario Doctor Peset
- Investigators
- Juan Soliveres, MD, PhD, Principal investigator, University Hospital Doctor Peset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399488
- Sponsor's protocol ID
- CEIC:47/10
- Status last verified
- Aug 2015
- First submitted
- 22 Mar 2015
- Last updated
- 18 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Soliveres J, Balaguer J, Estruch M, Sánchez A, Sánchez J. Validation of Continuous and Noninvasive Hemoglobin Monitoring from Pulse CO-Oximetry during Surgery. 2010 Annual Meeting of the American Society Anesthesiologists
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Continuous Noninvasive Haemoglobin Determination Monitor (Radical 7 Pulse CO-Oximeter, SpHb) Compared to the Central Laboratory Coulter (LabHb) and a Point of Care (POC) Invasive Cooximeter (COoxHb) After in Vivo Adjustment.
- ClinicalTrials.gov ID
- NCT02399488
- Acronym / sponsor ID
- CEIC:47/10
- Conditions
- Sphb Haemoglobin in Vivo Validation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Universitario Doctor PesetUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (estimated)
- First posted
- 26 Mar 2015 (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.
Continuous haemoglobin determination could improve the outcomes of several patients in risk of bleeding during surgery. An in vivo calibration has been introduced to the device after our team found its need. The uncalilbrated validation of the Masimo Radical 7 continuous haemoglobin monitor has been made in various papers, although it has been compared to point of care devices, thus introducing an error as such point of care devices although validated for haemoglobin determination, are not as accurate as the gold standard. The validation of the gold standard calibrated device has not been described yet.
When compared to the accepted gold standard (cyanmethemoglobin method, Coulter), accuracy and precision of the continuous haemoglobin monitor could be good enough to be used interchangeably with the gold standard.
Detailed description
Continuous haemoglobin determination could improve the outcomes of several patients in risk of bleeding during surgery.
The in vivo calibration has not been adjusted to the gold standard haemoglobin determination in the literature yet.
Two blood samples will be withdrawn at the same time from an arterial line, one for the central laboratory and the other one for the POC device. At the same exact time the SpHb measurement will be recorded. At least eight samples are expected per patient. A maximum of 20 samples will be withdrawn per patient.
To compare bias, precision and limits of agreement among SpHb, LabHb and COoxHb the Bland Altman method will be used with multiple observations per subject when the true value varies. An error grid analysis will be made to know how it could affect to clinical decision making.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled to any surgery of at least three hours of duration.
Key inclusion criteria (4 listed)
- Adult patients.
- Surgery duration of at least two hours.
- Patients scheduled to surgery under general anaesthesia and muscle relaxation.
- Radial arterial line needed for blood pressure control or other reason not related to the study.
Key exclusion criteria (4 listed)
- Radial arterial line not indicated / not possible to place.
- Sampling difficult or impossible.
- Need to reposition arterial line arm during surgery.
- Any illness that could influence the haemoglobin measurement.
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 Radical 7Simultaneous determination of haemoglobin with the continuous haemoglobin monitor, the central lanboratory coulter and a POC: | Device | – |
Primary outcome
Central coulter bias and limits of agreement
Time frame: 3 months
Bias and limits of agreement of SpHb compared to the central laboratory coulter
Central coulter bias and limits of agreement after in vivo calibration
Time frame: 3 months
Bias and limits of agreement of SpHb compared to the central laboratory coulter after in vivo Radical 7 calibration
3 secondary outcomes
POC Cooximeter bias and limits of agreement
Time frame: 3 months
POC Cooximeter bias and limits of agreement
Time frame: 3 months
POC Cooximeter Coulter interchangeability
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2015.
- BackgroundSoliveres J, Balaguer J, Estruch M, Sánchez A, Sánchez J. Validation of Continuous and Noninvasive Hemoglobin Monitoring from Pulse CO-Oximetry during Surgery. 2010 Annual Meeting of the American Society Anesthesiologists
- Citation linkLink provided by the sponsor.
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.
Juan Soliveres, MD, PhD contact
Juan Soliveres, MD, PhD principal investigator
University Hospital Doctor Peset
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 Sphb Haemoglobin in Vivo Validation, run by Hospital Universitario Doctor Peset at 1 site in Spain.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Aug 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Soliveres, MD, PhD (+34670758871), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central coulter bias and limits of agreement (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02399488, which also lists 1 linked publication.
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 18 Aug 2015.