Validity of Radical 7 Masimo Monitor at Measuring Hemoglobin in Pediatric Cardiac Intensive Care
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|ClinicalTrials.gov Identifier: NCT03977142|
Recruitment Status : Not yet recruiting
First Posted : June 6, 2019
Last Update Posted : June 6, 2019
|Condition or disease||Intervention/treatment|
|Evaluate the Accuracy of the Masimo Radical 7 Hemoglobin Noninvasive Monitor||Diagnostic Test: Radical 7 Masimo Hemoglobin pulse co-oximeter non invasive monitor|
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 Type :||Observational|
|Estimated Enrollment :||25 participants|
|Official Title:||Accuracy of the Noninvasive Radical-7 Pulse Co-oximeter at Detecting Hemoglobin Changes in Pediatric Cardiac Intensive Care|
|Estimated Study Start Date :||August 2019|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||August 2020|
- Diagnostic Test: Radical 7 Masimo Hemoglobin pulse co-oximeter non invasive monitor
Measure hemoglobin levels non invasively by pulse co-oximeter
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03977142
|Contact: Geneviève Du Pont-Thibodeau, MD, MSc||5143454931 ext email@example.com|