Congenital Heart DiseaseNCT03248830
Non-invasive Hemoglobin Monitoring in Congenital Heart Diseased Children
An observational study of Congenital Heart Disease, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 8 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- radical-7 pulse co-oximeter
- Type of treatment
- Medical device
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2018to 10 Sep 2019
- 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 1 month to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: The study will include children less than 8 years with congenital hear diseases scheduled for surgery or endo-vascular iintervention
Who may be able to join
- infants and children less than 8 years
- with congenital heart disease
Who cannot join
- refusal of the patient surrogate to share in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Non-invasive Hemoglobin Monitoring in Children With Congenital Heart Diseases
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.
Read the detailed description
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.
- Conditions
- Congenital Heart Disease
- Being tested
- radical-7 pulse co-oximeter
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radical-7 pulse co-oximeterDevice
Also called Masimo 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
What is being measured
The primary outcome is the main question the study is designed to answer.
non-invasive hemoglobin
the value of hemoglobin measured by radical-7 device in g/dL
Measured: 5 hours
Secondary outcomes (8)
laboratory hemoglobin
the value of hemoglobin measured from a blood sample in the laboratory in g/dL
Measured: 5 hours
perfusion index
the percentage of perfusion index measured by radical-7 device
Measured: 5 hours
plethysmography variability index
the percentage of plethysmography variability index measured by radical-7 device
Measured: 5 hours
systolic blood pressure
systolic blood pressure measured in mmHg
Measured: 5 hours
diastolic blood pressure
diastolic blood pressure measured in mmHg
Measured: 5 hours
oxygen saturation from radical-7 device
oxygen saturation measured by radical-7 device
Measured: 5 hours
oxygen saturation from arterial blood gases
oxygen saturation measured from arterial blood gases
Measured: 5 hours
heart rate
number of heart beats per minute
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start20 Feb 2018
- Primary completion1 Aug 2019
- Study completion10 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
- Investigators
- Ahmed Mukhtar, Professor, Study director, Head of research committee section in anesthesia department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248830
- Sponsor's protocol ID
- N-99-2017
- Status last verified
- Sep 2019
- First submitted
- 10 Aug 2017
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Non-invasive Hemoglobin Monitoring in Children With Congenital Heart Diseases
- ClinicalTrials.gov ID
- NCT03248830
- Acronym / sponsor ID
- N-99-2017
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 14 Aug 2017 (actual)
- 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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study will include children less than 8 years with congenital hear diseases scheduled for surgery or endo-vascular iintervention
Key inclusion criteria (2 listed)
- infants and children less than 8 years
- with congenital heart disease
Key exclusion criteria (1 listed)
- refusal of the patient surrogate to share in the study
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 |
|---|---|---|
| radical-7 pulse co-oximeterAlso: Masimo pulse co-oximeterRadical-7 pulse co-oximter will be applied to the patient through a special probe attached the the patient digit to measure blood hemoglobin | Device | – |
Primary outcome
non-invasive hemoglobin
Time frame: 5 hours
the value of hemoglobin measured by radical-7 device in g/dL
8 secondary outcomes
laboratory hemoglobin
Time frame: 5 hours
perfusion index
Time frame: 5 hours
plethysmography variability index
Time frame: 5 hours
systolic blood pressure
Time frame: 5 hours
diastolic blood pressure
Time frame: 5 hours
oxygen saturation from radical-7 device
Time frame: 5 hours
oxygen saturation from arterial blood gases
Time frame: 5 hours
heart rate
Time frame: 5 hours
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 1 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Ahmed Mukhtar, Professor study director
Head of research committee section in anesthesia department
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 Congenital Heart Disease, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 1 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 1 Oct 2019. 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 Egypt. 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?
non-invasive hemoglobin (time frame: 5 hours). 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 1 Oct 2019.