Non-invasive Hemoglobin Monitoring in Congenital Heart Diseased Children
NCT ID: NCT03248830
Last Updated: 2019-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
56 participants
OBSERVATIONAL
2018-02-20
2019-09-10
Brief Summary
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Detailed Description
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Radical-7 (Masimo corporation, Irvine, CA) is a device that operates using the principle of co-oximetry . Radical-7 had been validated in various clinical purposes. Measurement of blood hemoglobin is an important application for Radical-7 device. Non-invasive hemoglobin (Sp-Hb) measurement has been frequently validated in adults; as well as in pediatric patients; however, its accuracy in children with congenital heart disease was not investigated. Congenital heart disease infants usually undergo major operations and frequently need transfusion of blood. Moreover, these patients have special circulatory physiology that might impact the device accuracy. It had been recently reported that the performance of co-oximetry in congenital heart disease children is poor in measurement of oxygen saturation specially at oxygen saturation under 75%; however, its accuracy in measurement of hemoglobin was not investigated yet. In this study, the investigators will evaluate the accuracy of Sp-Hb compared to traditional Lab-Hb in children with congenital heart disease. the investigators will also compare the accuracy of Sp-Hb in cyanotic children to acyanotic children.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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radical-7 pulse co-oximeter
Radical-7 pulse co-oximter will be applied to the patient through a special probe attached the the patient digit to measure blood hemoglobin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* with congenital heart disease
Exclusion Criteria
1 Month
8 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Ahmed Hasanin
Assistant professor
Principal Investigators
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Ahmed Mukhtar, Professor
Role: STUDY_DIRECTOR
Head of research committee section in anesthesia department
Locations
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Cairo University
Cairo, , Egypt
Countries
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Other Identifiers
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N-99-2017
Identifier Type: -
Identifier Source: org_study_id
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