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Trial record 48 of 620 for:    oximeter

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
Sponsor:
Information provided by (Responsible Party):
Genevieve Du Pont-Thibodeau, St. Justine's Hospital

Brief 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. 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.

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

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.


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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Intervention Details:
  • Diagnostic Test: Radical 7 Masimo Hemoglobin pulse co-oximeter non invasive monitor
    Measure hemoglobin levels non invasively by pulse co-oximeter


Primary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Children admitted to the PICU after a cardiac surgery
Criteria

Inclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Geneviève Du Pont-Thibodeau, MD, MSc 5143454931 ext 5553 genevievedpt@gmail.com

Sponsors and Collaborators
St. Justine's Hospital

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Responsible Party: Genevieve Du Pont-Thibodeau, Pediatric Intensivist, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT03977142     History of Changes
Other Study ID Numbers: HgPCICU
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No