ChildHEMOPED2NCT03624140
A Comparison of Three Methods of Hemoglobin Monitoring in Pediatric Patients
A study testing blood measurement, pulse co-oxymeter (SpHb) and hemoCue in people with Child, run by Central Hospital, Nancy, France.
Trial summary
Investigators compare the accuracy of the SpHb and hemocue with blood Hb levels Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Child
- What is being tested?
- blood measurement, pulse co-oxymeter (SpHb) and hemoCue
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to May 2023
- Phase
- Interventional
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Paediatric patients scheduled for surgery under general anesthesia
- Arterial catheter necessary in the anesthetic protocol
- BMI<30
- Written consent of holders of parental authority
- No opposition of children
Who cannot join
- Hemoglobine disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Hemoglobin Monitoring During High Bleeding Risk Surgery in Pediatric Patients: Equivalence Study of Hemoglobin Transcutaneous Saturation and Hemocue With Total Serum Hemoglobin
Investigators compare the accuracy of the SpHb and hemocue with blood Hb levels
Read the detailed description
The goal of the study is to compare 3 methods of hemoglobin measurement in pediatric patients undergoing major surgery. During general anesthesia investigators will measure and compare at different periods of time blood hemoglobin levels obtained from a radial artery catheter with 2 non invasive methods of measurement using hemocue and SpHb
- Conditions
- Child
- Being tested
- blood measurement, pulse co-oxymeter (SpHb), hemoCue
- Keywords
- major pediatric surgery, hemoglobin measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood measurementDevice
Hemoglobin measurement
pulse co-oxymeter (SpHb)Device
non invasive method of hemoglobin measurement
hemoCueDevice
non invasive method of hemoglobin measurement
| Study group | Role | What they receive |
|---|---|---|
| Hemoglobin monitoring | Experimental | 3 different techniques will be used for hemoglobine monitoring : hemocue, pulse co-oxymeter (SpHb) and blood measurement Receives: Device: blood measurement; Device: pulse co-oxymeter (SpHb); Device: hemoCue |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of hemoglobin using 3 different techniques at the time of transfusion decision
comparison of blood hemoglobin obtained by arterial samples with 2 non invasive methods of measurement using hemocue and SpHb
Measured: within the day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study startMar 2019 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Blood measurement
- Masking
- None (open label)
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624140
- Sponsor's protocol ID
- 2018-A01379-46
- Acronym
- HEMOPED2
- Status last verified
- Feb 2019
- First submitted
- 7 Aug 2018
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemoglobin Monitoring During High Bleeding Risk Surgery in Pediatric Patients: Equivalence Study of Hemoglobin Transcutaneous Saturation and Hemocue With Total Serum Hemoglobin
- ClinicalTrials.gov ID
- NCT03624140
- Acronym / sponsor ID
- HEMOPED2 / 2018-A01379-46
- Conditions
- Child
- Keywords
- major pediatric surgery, hemoglobin measurement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 9 Aug 2018 (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.
Investigators compare the accuracy of the SpHb and hemocue with blood Hb levels
Detailed description
The goal of the study is to compare 3 methods of hemoglobin measurement in pediatric patients undergoing major surgery. During general anesthesia investigators will measure and compare at different periods of time blood hemoglobin levels obtained from a radial artery catheter with 2 non invasive methods of measurement using hemocue and SpHb
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Blood measurement
| Arm | Type | Receives |
|---|---|---|
| Hemoglobin monitoring | Experimental | Device: blood measurement, Device: pulse co-oxymeter (SpHb), Device: hemoCue3 different techniques will be used for hemoglobine monitoring : hemocue, pulse co-oxymeter (SpHb) and blood measurement |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Paediatric patients scheduled for surgery under general anesthesia
- Arterial catheter necessary in the anesthetic protocol
- BMI<30
- Written consent of holders of parental authority
- No opposition of children
Key exclusion criteria (1 listed)
- Hemoglobine disease
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 |
|---|---|---|
| blood measurementHemoglobin measurement | Device | Hemoglobin monitoring |
| pulse co-oxymeter (SpHb)non invasive method of hemoglobin measurement | Device | Hemoglobin monitoring |
| hemoCuenon invasive method of hemoglobin measurement | Device | Hemoglobin monitoring |
Primary outcome
level of hemoglobin using 3 different techniques at the time of transfusion decision
Time frame: within the day of surgery
comparison of blood hemoglobin obtained by arterial samples with 2 non invasive methods of measurement using hemocue and SpHb
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing blood measurement, pulse co-oxymeter (SpHb) and hemoCue in people with Child, run by Central Hospital, Nancy, France.
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 5 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: status not confirmed, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claude MEISTELMAN, PhD (00 33 3 83 15 41 66, c.meistelman@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of hemoglobin using 3 different techniques at the time of transfusion decision (time frame: within the day of surgery). 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 27 Feb 2019.