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Completed

NCT Number: NCT03248830

Non-invasive Hemoglobin Monitoring in Congenital Heart Diseased Children

The investigators will evaluate the accuracy of non-invasive hemoglobin monitor (Sp-Hb) compared to traditional laboratory hemoglobin (Lab-Hb) in children with congenital heart disease. The investigators will also compare the accuracy of Sp-Hb in cyanotic children to acyanotic children.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

1 month–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cairo University

Cairo, Egypt

About this study

Blood hemoglobin is measured daily in clinical practice. Laboratory measurement (Lab-Hb) of is the gold standard for assessment of blood hemoglobin. Recently, non-invasive monitors had been introduced. Non-invasive measurement of hemoglobin (Sp-Hb) would save time and minimize the risk of infection. Blood sampling in children is usually more difficult and stressful; moreover, it also carries the risk of iatrogenic anemia.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • infants and children less than 8 years
  • with congenital heart disease

Exclusion criteria

  • refusal of the patient surrogate to share in the study

Treatment and study plan

radical-7 pulse co-oximeter

Device

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 names: Masimo pulse co-oximeter

Primary outcomes

  1. non-invasive hemoglobin

    Time frame: 5 hours

    the value of hemoglobin measured by radical-7 device in g/dL

Secondary outcomes

  1. laboratory hemoglobin

    Time frame: 5 hours

    the value of hemoglobin measured from a blood sample in the laboratory in g/dL

  2. perfusion index

    Time frame: 5 hours

    the percentage of perfusion index measured by radical-7 device

  3. plethysmography variability index

    Time frame: 5 hours

    the percentage of plethysmography variability index measured by radical-7 device

  4. systolic blood pressure

    Time frame: 5 hours

    systolic blood pressure measured in mmHg

  5. diastolic blood pressure

    Time frame: 5 hours

    diastolic blood pressure measured in mmHg

  6. oxygen saturation from radical-7 device

    Time frame: 5 hours

    oxygen saturation measured by radical-7 device

  7. oxygen saturation from arterial blood gases

    Time frame: 5 hours

    oxygen saturation measured from arterial blood gases

  8. heart rate

    Time frame: 5 hours

    number of heart beats per minute

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of Non-invasive Hemoglobin Monitoring in Children With Congenital Heart Diseases

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 14, 2017
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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