Hemoglobin ResultsNCT01750463
Comparing Validity of Non-Invasive Hemoglobin Monitoring to Laboratory Results in Critically Ill Children
An observational study of Hemoglobin Results, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This is a prospective study to determine the accuracy of the Masimo Pronto Non-Invasive Hemoglobin Monitor and associated Rainbow® probes in the detection of hemoglobin concentration in critically ill children. Read more about this study
- Who is it for?
- Ages 30 days to 18 years
- Conditions the study is for
- Hemoglobin Results
- What is being tested?
- Masimo Pronto Rad 7 Non-Invasive hemoglobin monitor and Standard Laboratory Blood Draw and Hemoglobin Analysis
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to May 2013
- 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 30 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric patients admitted to the PICU requiring hemoglobin monitoring
Who may be able to join
- Patient has been admitted to Pediatric Intensive Care Unit
- Patient age is ≥ 30 days old and ≤ 18 years old
- Patient weight ≥ 3 Kg.
- Patient requires hemoglobin monitoring
Who cannot join
- Patient does not have exposed fingers/toes,due to congenital anomalies wound dressing or injury.
- Patient weight is less than 3 Kg
- Patient is less than 30 days old
Trial locations and contacts
1 site in 1 country.
United States1 site
Pediatric Intensive Care Unit, University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: Verifying the Accuracy of the Masimo Pronto Non-Invasive Hemoglobin (Hb) Monitor and Associated Rainbow Probes Compared to Measured Laboratory Values in Critically Ill Pediatric Patients
This is a prospective study to determine the accuracy of the Masimo Pronto Non-Invasive Hemoglobin Monitor and associated Rainbow® probes in the detection of hemoglobin concentration in critically ill children.
Read the detailed description
This is a prospective study to determine the accuracy of the Masimo Pronto Non-Invasive Hemoglobin Monitor and associated Rainbow® probes in the detection of hemoglobin concentration in critically ill children. Data from at least 30 patients admitted to the Pediatric Intensive Care Unit (PICU) over a period of 2 months will be collected and analyzed for this study.
Note, that this device would not lead to deviations in routine patient care; specifically, the non-invasive monitor placed on the patient's finger is FDA approved. The proposed monitors are identical macroscopically to monitors, which are currently used to measure oxygen saturation at this institution. Clinical decisions, additional blood draws or alterations to the plan of care will not be made based on study data. The objective is to compare the validity of the hemoglobin values determined from non-invasive technology with measured laboratory values for hemoglobin utilized as standard of care.
- Conditions
- Hemoglobin Results
- Being tested
- Masimo Pronto Rad 7 Non-Invasive hemoglobin monitor, Standard Laboratory Blood Draw and Hemoglobin Analysis
- Keywords
- Pediatric critically ill, Masimo, hemoglobin, monitoring, UNC, PICU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo Pronto Rad 7 Non-Invasive hemoglobin monitorOther
Also called Rainbow adhesive sonsor R1 20L, Rainbow reusable spot check sensor DCIP SC-200, Rainbow reusable spot check sensor DCI SC-200
Patients admitted to PICU requiring hemoglobin monitoring will have a total hemoglobin (SpHb) assessment from Masimo non-invasive monitor, prior to standard, required blood draw and laboratory analysis.
Standard Laboratory Blood Draw and Hemoglobin AnalysisOther
Patients admitted to PICU requiring hemoglobin monitoring will have a reading from Masimo non-invasive monitor, prior to standard, required blood draw and laboratory analysis.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Critically ill pediatric patients admitted to PICU requiring hemoglobin monitoring.
Patients admitted to PICU requiring hemoglobin monitoring will have a reading total hemoglobin (SpHb) assessment done with the Masimo Pronto Rad 7 Non-Invasive hemoglobin monitor,prior to standard laboratory blood draw and hemoglobin analysis. Receives: Other: Masimo Pronto Rad 7 Non-Invasive hemoglobin monitor; Other: Standard Laboratory Blood Draw and Hemoglobin Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of standard hemoglobin monitoring vs. the MASIO non-invasive hemoglobin monitor
We will obtain measurements using the Masimo Pronto device prior to the standard lab draw at the following time points: post admission to PICU, 12-48 hours. We will then perform analysis using Bland Altman methods to determine the degree of agreement.
Data analysis will occur 1 year after enrollment completion.
Measured: up to 48 hours, post PICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemoglobin ResultsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean McLean, MD, University of North Carolina, Chapel Hill
- Investigators
- Michael Phillips, MD, Principal investigator, University of North Carolina,Chapel Hill, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750463
- Sponsor's protocol ID
- 12-2019
- Status last verified
- Dec 2014
- First submitted
- 5 Dec 2012
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verifying the Accuracy of the Masimo Pronto Non-Invasive Hemoglobin (Hb) Monitor and Associated Rainbow Probes Compared to Measured Laboratory Values in Critically Ill Pediatric Patients
- ClinicalTrials.gov ID
- NCT01750463
- Acronym / sponsor ID
- 12-2019
- Conditions
- Hemoglobin Results
- Keywords
- Pediatric critically ill, Masimo, hemoglobin, monitoring, UNC, PICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 17 Dec 2012 (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.
This is a prospective study to determine the accuracy of the Masimo Pronto Non-Invasive Hemoglobin Monitor and associated Rainbow® probes in the detection of hemoglobin concentration in critically ill children.
Detailed description
This is a prospective study to determine the accuracy of the Masimo Pronto Non-Invasive Hemoglobin Monitor and associated Rainbow® probes in the detection of hemoglobin concentration in critically ill children. Data from at least 30 patients admitted to the Pediatric Intensive Care Unit (PICU) over a period of 2 months will be collected and analyzed for this study.
Note, that this device would not lead to deviations in routine patient care; specifically, the non-invasive monitor placed on the patient's finger is FDA approved. The proposed monitors are identical macroscopically to monitors, which are currently used to measure oxygen saturation at this institution. Clinical decisions, additional blood draws or alterations to the plan of care will not be made based on study data. The objective is to compare the validity of the hemoglobin values determined from non-invasive technology with measured laboratory values for hemoglobin utilized as standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | – | Other: Masimo Pronto Rad 7 Non-Invasive hemoglobin monitor, Other: Standard Laboratory Blood Draw and Hemoglobin AnalysisCritically ill pediatric patients admitted to PICU requiring hemoglobin monitoring. Patients admitted to PICU requiring hemoglobin monitoring will have a reading total hemoglobin (SpHb) assessment done with the Masimo Pronto Rad 7 Non-Invasive hemoglobin monitor,prior to standard laboratory blood draw and hemoglobin analysis. |
Who may qualify
- Ages
- 30 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric patients admitted to the PICU requiring hemoglobin monitoring
Key inclusion criteria (4 listed)
- Patient has been admitted to Pediatric Intensive Care Unit
- Patient age is ≥ 30 days old and ≤ 18 years old
- Patient weight ≥ 3 Kg.
- Patient requires hemoglobin monitoring
Key exclusion criteria (3 listed)
- Patient does not have exposed fingers/toes,due to congenital anomalies wound dressing or injury.
- Patient weight is less than 3 Kg
- Patient is less than 30 days old
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 Pronto Rad 7 Non-Invasive hemoglobin monitorAlso: Rainbow adhesive sonsor R1 20L, Rainbow reusable spot check sensor DCIP SC-200, Rainbow reusable spot check sensor DCI SC-200Patients admitted to PICU requiring hemoglobin monitoring will have a total hemoglobin (SpHb) assessment from Masimo non-invasive monitor, prior to standard, required blood draw and laboratory analysis. | Other | Arm A |
| Standard Laboratory Blood Draw and Hemoglobin AnalysisPatients admitted to PICU requiring hemoglobin monitoring will have a reading from Masimo non-invasive monitor, prior to standard, required blood draw and laboratory analysis. | Other | Arm A |
Primary outcome
Comparison of standard hemoglobin monitoring vs. the MASIO non-invasive hemoglobin monitor
Time frame: up to 48 hours, post PICU admission
We will obtain measurements using the Masimo Pronto device prior to the standard lab draw at the following time points: post admission to PICU, 12-48 hours. We will then perform analysis using Bland Altman methods to determine the degree of agreement. Data analysis will occur 1 year after enrollment completion.
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 3 Dec 2014.
Related trials for Hemoglobin Results
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.
Michael Phillips, MD principal investigator
University of North Carolina,Chapel Hill, NC
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 Hemoglobin Results, run by University of North Carolina, Chapel Hill 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 4 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: finished, as of the sponsor's last update on 3 Dec 2014. 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?
Comparison of standard hemoglobin monitoring vs. the MASIO non-invasive hemoglobin monitor (time frame: up to 48 hours, post PICU admission). 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 3 Dec 2014.