Non-invasive Hb Measurement in ChildrenNCT01693016
Validation of Non-invasive Hemoglobin (SpHb) Measurement in Children
A study testing non-invasive measurement of Hb and taking blood samples in people with Non-invasive Hb Measurement in Children, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the value of the new technique of non-invasive measurement of Hb in children undergoing a surgical procedure. Read more about this study
- Who is it for?
- Ages Up to 8 years
- Conditions the study is for
- Non-invasive Hb Measurement in Children
- What is being tested?
- non-invasive measurement of Hb and taking blood samples
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2012to Jan 2013
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children (>= 3 kg until 8 years)
- ASA I-III
- written informed consent of legal representative
Who cannot join
- children <= 3kg or > 8 years
- emergency surgery
- allergy against sensor of SpHb(®)
- artery occlusive disease
- sepsis
- haemoglobinopathy
- specific medical or psychological circumstances which do not allow the consent of the legal representative or the performance of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Non-invasive Hb-measurement (SpHb) in Children With the Masimo@ Radical 7
The purpose of this study is to evaluate the value of the new technique of non-invasive measurement of Hb in children undergoing a surgical procedure.
Read the detailed description
Several surgical procedures require haemoglobin monitoring due to possible blood loss and the need of blood transfusion. The standard for monitoring hemoglobin (Hb) is the measurement of blood samples. The novel technique of non-invasive continuous measurement of Hb using Pulse CO-Oximetry may allow measuring Hb without obtaining blood samples.
This new technique has not been tested yet in children undergoing anesthesia for elective surgical procedures. In this study the investigators compare the non-invasive Hb measurement with Masimo® technology (SpHb) with the standard Hb measurement using ABL-800 Flex (BGA) and Siemens Advia (labHb, reference method) before the children undergo the surgical procedure.
- Conditions
- Non-invasive Hb Measurement in Children
- Being tested
- non-invasive measurement of Hb, taking blood samples
- Keywords
- non-invasive Hb measurement in children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive measurement of HbDevice
Also called SpHb (®) by Masimo ® Radical 7
taking blood samplesProcedure or surgery
Also called blood for BGA (ABL 800), blood for laboratory Hb (Siemens Advia)
| Study group | Role | What they receive |
|---|---|---|
| inhalation group | Other | 20 children Taking blood samples and SpHb-measurement was made under inhalational anesthesia Receives: Device: non-invasive measurement of Hb; Procedure: taking blood samples |
| non-inhalational | Other | 40 children Taking blood samples and SpHb measurements in awake and spontaneous breathing children. Receives: Device: non-invasive measurement of Hb; Procedure: taking blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between SpHb(®) and the Hb measured by the ABL800Flex and the Siemens Advia
Measured: one day
Secondary outcomes (1)
influence of inhalation anesthetics
The blood samples are taken from the needle infusion set the child gets for anesthesia. Some children will need an inhalational induction of anesthesia before they can get the needle and the sensor for the SpHb (®) monitoring. So an influence of the application of inhalation anesthetics on the accuracy of the SpHb (®) will be tested.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-invasive Hb Measurement in ChildrenStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Eva Wittenmeier, Johannes Gutenberg University Mainz
- Investigators
- Eva Wittenmeier, Principal investigator, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693016
- Sponsor's protocol ID
- MASIMO 2012
- Status last verified
- Mar 2014
- First submitted
- 19 Sep 2012
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wittenmeier E, Bellosevich S, Mauff S, Schmidtmann I, Eli M, Pestel G, Noppens RR. Comparison of the gold standard of hemoglobin measurement with the clinical standard (BGA) and noninvasive hemoglobin measurement (SpHb) in small children: a prospective diagnostic observational study. Paediatr Anaesth. 2015 Oct;25(10):1046-53. doi: 10.1111/pan.12683. Epub 2015 Jul 14.
PubMed 26179143
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Non-invasive Hb-measurement (SpHb) in Children With the Masimo@ Radical 7
- ClinicalTrials.gov ID
- NCT01693016
- Acronym / sponsor ID
- MASIMO 2012
- Conditions
- Non-invasive Hb Measurement in Children
- Keywords
- non-invasive Hb measurement in children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 26 Sep 2012 (estimated)
- 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 purpose of this study is to evaluate the value of the new technique of non-invasive measurement of Hb in children undergoing a surgical procedure.
Detailed description
Several surgical procedures require haemoglobin monitoring due to possible blood loss and the need of blood transfusion. The standard for monitoring hemoglobin (Hb) is the measurement of blood samples. The novel technique of non-invasive continuous measurement of Hb using Pulse CO-Oximetry may allow measuring Hb without obtaining blood samples.
This new technique has not been tested yet in children undergoing anesthesia for elective surgical procedures. In this study the investigators compare the non-invasive Hb measurement with Masimo® technology (SpHb) with the standard Hb measurement using ABL-800 Flex (BGA) and Siemens Advia (labHb, reference method) before the children undergo the surgical procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inhalation group | Other | Device: non-invasive measurement of Hb, Procedure: taking blood samples20 children Taking blood samples and SpHb-measurement was made under inhalational anesthesia |
| non-inhalational | Other | Device: non-invasive measurement of Hb, Procedure: taking blood samples40 children Taking blood samples and SpHb measurements in awake and spontaneous breathing children. |
Who may qualify
- Ages
- Up to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children (>= 3 kg until 8 years)
- ASA I-III
- written informed consent of legal representative
Key exclusion criteria (7 listed)
- children <= 3kg or > 8 years
- emergency surgery
- allergy against sensor of SpHb(®)
- artery occlusive disease
- sepsis
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 |
|---|---|---|
| non-invasive measurement of HbAlso: SpHb (®) by Masimo ® Radical 7 | Device | inhalation group, non-inhalational |
| taking blood samplesAlso: blood for BGA (ABL 800), blood for laboratory Hb (Siemens Advia) | Procedure or surgery | inhalation group, non-inhalational |
Primary outcome
correlation between SpHb(®) and the Hb measured by the ABL800Flex and the Siemens Advia
Time frame: one day
1 secondary outcome
influence of inhalation anesthetics
Time frame: one day
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 26 Mar 2014.
- Derived from this study: PubMed 26179143Wittenmeier E, Bellosevich S, Mauff S, Schmidtmann I, Eli M, Pestel G, Noppens RR. Comparison of the gold standard of hemoglobin measurement with the clinical standard (BGA) and noninvasive hemoglobin measurement (SpHb) in small children: a prospective diagnostic observational study. Paediatr Anaesth. 2015 Oct;25(10):1046-53. doi: 10.1111/pan.12683. Epub 2015 Jul 14.
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.
Eva Wittenmeier principal investigator
Johannes Gutenberg University Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-invasive measurement of Hb and taking blood samples in people with Non-invasive Hb Measurement in Children, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 3 inclusion and 7 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 26 Mar 2014. 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 Germany. 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?
correlation between SpHb(®) and the Hb measured by the ABL800Flex and the Siemens Advia (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01693016, which also lists 1 linked publication.
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 26 Mar 2014.