Evaluate the Accuracy of the Masimo Radical 7 Hemoglobin Noninvasive MonitorNCT03977142
Validity of Radical 7 Masimo Monitor at Measuring Hemoglobin in Pediatric Cardiac Intensive Care
An observational study of Evaluate the Accuracy of the Masimo Radical 7 Hemoglobin Noninvasive Monitor, run by St. Justine's Hospital.
Trial summary
Fifty percent of children that survive a critical illness are anemic at discharge from the pediatric intensive care unit (PICU)(1). Given that there are approximately 9000 PICU admissions/year in Canada, this represents almost 4500 children per year. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Evaluate the Accuracy of the Masimo Radical 7 Hemoglobin Noninvasive Monitor
- What is being tested?
- Radical 7 Masimo Hemoglobin pulse co-oximeter non invasive monitor
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to Aug 2020
- 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 Up to 6 months
- All sexes
- Child
Study population: Children admitted to the PICU after a cardiac surgery
Who may be able to join
- 1) patients that are admitted to the PICU of the CHUSJ after a cardiac surgery, 2) that are aged less than 6 months on the day of admission and that 3) have an arterial line inserted.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Accuracy of the Noninvasive Radical-7 Pulse Co-oximeter at Detecting Hemoglobin Changes in Pediatric Cardiac Intensive Care
Fifty percent of children that survive a critical illness are anemic at discharge from the pediatric intensive care unit (PICU)(1). Given that there are approximately 9000 PICU admissions/year in Canada, this represents almost 4500 children per year. Anemia is associated with abnormal neurocognitive development in infants and young children. A contributor to PICU anemia is the excessive amount of blood testing and iatrogenic blood losses(2). Non-invasive continuous hemoglobin monitoring (Sp-Hb) have been developed in the medical setting in an attempt to minimize invasive blood testing and reduce blood losses. The Radical 7 Masimo device (Masimo corporation, Irvine, CA) is one of the popular devices used for non-invasive hemoglobin monitoring. Its accuracy has been previously investigated in various populations(3-6). The objective of this study is to investigate the validity of the Radical 7 Masimo device at measuring hemoglobin trends non-invasively in critically ill children.
Read the detailed description
This will be a prospective observational study. We will include 1) all patients that are admitted to the PICU of the CHUSJ after a cardiac surgery, 2) that are aged less than 6 months on the day of admission and that 3) have an arterial line inserted.
All children studied will have an arterial line inserted at the time of surgery that will allow for arterial-Hb measurements. As this study is strictly observational, all arterial-Hb measurements will be requested by the medical treating team as clinically indicated. We will install, on admission, the spectrophotometric adhesive sensor required for Sp-Hb measurements on each patient (Masimo Rainbow R1 20 for children over 30 kg and R1 20L for those under 30 kg). The sensor will be applied on the hand or foot that does not have an arterial cannula. The sensor will be covered with an impermeable black shield to prevent optical interference.
We will collect all the arterial-Hb measurements performed in the 48 hours after PICU admission as well as all the Sp-Hb readings performed at the time of the arterial samples. The blood samples drawn from the arterial catheter will be analyzed using a laboratory CO-oximeter (model ABL820; Radiometer, Copenhagen, Denmark). Simultaneous recording of Sp-Hb will performed within 10 seconds after the arterial blood sample is drawn. We will also collect demographic data and clinical data on each patient; age, weight, sex, ethnicity, type of cardiac surgery, blood transfusions. At the CHUSJ PICU, all clinical and demographic data is systematically recorded in our electronic database (Intellispace Critical Care and Anesthesia, Philips Medical Systems). Data on red cell transfusions are recorded through the TracelineTM database that is made available to our research group through Héma-Québec. Data will be extracted from our database by our research assistant.
- Being tested
- Radical 7 Masimo Hemoglobin pulse co-oximeter non invasive monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical 7 Masimo Hemoglobin pulse co-oximeter non invasive monitorDiagnostic test
Measure hemoglobin levels non invasively by pulse co-oximeter
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the precision of the Radical-7 pulse co-oximeter at detecting changes in Hb levels when comparted to arterial-Hb levels changes in children admitted to the PICU after a cardiac surgery.
Measured: 3 months
To determine the precision of the Radical-7 pulse co-oximeter at measuring Hb values when compared to arterial-Hb in children admitted to the PICU after a cardiac surgery.
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 posted6 Jun 2019
- Study startAug 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluate the Accuracy of the Masimo Radical 7 Hemoglobin Noninvasive MonitorStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Genevieve Du Pont-Thibodeau, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977142
- Sponsor's protocol ID
- HgPCICU
- Status last verified
- Jun 2019
- First submitted
- 5 Jun 2019
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of the Noninvasive Radical-7 Pulse Co-oximeter at Detecting Hemoglobin Changes in Pediatric Cardiac Intensive Care
- ClinicalTrials.gov ID
- NCT03977142
- Acronym / sponsor ID
- HgPCICU
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 6 Jun 2019 (actual)
- 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.
Fifty percent of children that survive a critical illness are anemic at discharge from the pediatric intensive care unit (PICU)(1). Given that there are approximately 9000 PICU admissions/year in Canada, this represents almost 4500 children per year. Anemia is associated with abnormal neurocognitive development in infants and young children. A contributor to PICU anemia is the excessive amount of blood testing and iatrogenic blood losses(2). Non-invasive continuous hemoglobin monitoring (Sp-Hb) have been developed in the medical setting in an attempt to minimize invasive blood testing and reduce blood losses. The Radical 7 Masimo device (Masimo corporation, Irvine, CA) is one of the popular devices used for non-invasive hemoglobin monitoring. Its accuracy has been previously investigated in various populations(3-6). The objective of this study is to investigate the validity of the Radical 7 Masimo device at measuring hemoglobin trends non-invasively in critically ill children.
Detailed description
This will be a prospective observational study. We will include 1) all patients that are admitted to the PICU of the CHUSJ after a cardiac surgery, 2) that are aged less than 6 months on the day of admission and that 3) have an arterial line inserted.
All children studied will have an arterial line inserted at the time of surgery that will allow for arterial-Hb measurements. As this study is strictly observational, all arterial-Hb measurements will be requested by the medical treating team as clinically indicated. We will install, on admission, the spectrophotometric adhesive sensor required for Sp-Hb measurements on each patient (Masimo Rainbow R1 20 for children over 30 kg and R1 20L for those under 30 kg). The sensor will be applied on the hand or foot that does not have an arterial cannula. The sensor will be covered with an impermeable black shield to prevent optical interference.
We will collect all the arterial-Hb measurements performed in the 48 hours after PICU admission as well as all the Sp-Hb readings performed at the time of the arterial samples. The blood samples drawn from the arterial catheter will be analyzed using a laboratory CO-oximeter (model ABL820; Radiometer, Copenhagen, Denmark). Simultaneous recording of Sp-Hb will performed within 10 seconds after the arterial blood sample is drawn. We will also collect demographic data and clinical data on each patient; age, weight, sex, ethnicity, type of cardiac surgery, blood transfusions. At the CHUSJ PICU, all clinical and demographic data is systematically recorded in our electronic database (Intellispace Critical Care and Anesthesia, Philips Medical Systems). Data on red cell transfusions are recorded through the TracelineTM database that is made available to our research group through Héma-Québec. Data will be extracted from our database by our research assistant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Age groups
- Child
- Study population
- Children admitted to the PICU after a cardiac surgery
Key inclusion criteria (1 listed)
- 1) patients that are admitted to the PICU of the CHUSJ after a cardiac surgery, 2) that are aged less than 6 months on the day of admission and that 3) have an arterial line inserted.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Radical 7 Masimo Hemoglobin pulse co-oximeter non invasive monitorMeasure hemoglobin levels non invasively by pulse co-oximeter | Diagnostic test | – |
Primary outcome
To determine the precision of the Radical-7 pulse co-oximeter at detecting changes in Hb levels when comparted to arterial-Hb levels changes in children admitted to the PICU after a cardiac surgery.
Time frame: 3 months
To determine the precision of the Radical-7 pulse co-oximeter at measuring Hb values when compared to arterial-Hb in children admitted to the PICU after a cardiac surgery.
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 6 Jun 2019.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Evaluate the Accuracy of the Masimo Radical 7 Hemoglobin Noninvasive Monitor, run by St. Justine's Hospital.
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 0 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 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Geneviève Du Pont-Thibodeau, MD, MSc (5143454931 ext. 5553, genevievedpt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the precision of the Radical-7 pulse co-oximeter at detecting changes in Hb levels when comparted to arterial-Hb levels changes in children admitted to the PICU after a cardiac surgery. (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?
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 6 Jun 2019.