AnesthesiaHb-O2NCT01654913
Influence of Oxygen on Non-invasive Measurement of Hemoglobin
A study testing hemoglobin measurement in people with Anesthesia, run by Hopital Foch at 2 sites in France.
Trial summary
This study examines the effect of oxygen supplementation on the non-invasive measurement of hemoglobin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- hemoglobin measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesFrance
- Study dates
- Jul 2012to Nov 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients scheduled for a potentially hemorrhagic surgical procedure
Who cannot join
- anomaly (malformation, infection, swelling, irritation, ulceration, degenerative changes or significant edema) of the fingers,
- tremors.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Influence of the Inspired Oxygen Fraction on the Noninvasive Measurement of Hemoglobin Using Two Different Devices (Namely Pronto 7 and NBM-200)
This study examines the effect of oxygen supplementation on the non-invasive measurement of hemoglobin.
- Conditions
- Anesthesia
- Being tested
- hemoglobin measurement
- Keywords
- hemoglobin determination, oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemoglobin measurementDevice
Non invasive hemoglobin measurements (Pronto 7 device and NBM-200 device)will be made with :
- at baseline (simultaneous blood sample for a laboratory measurement of hemoglobin),
- with the patient breathing oxygen via a face-mask (FiO2 50 ± 5%),
- with the patient breathing oxygen via a face-mask (FiO2 90 ± 5%) (simultaneous blood sample for a laboratory measurement of hemoglobin).
| Study group | Role | What they receive |
|---|---|---|
| surgical patients | Experimental | patients studied just before induction of anesthesia Receives: Device: hemoglobin measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
influence of the inspired oxygen fraction on the noninvasive measurement of hemoglobin (Pronto 7 and NBM-200 devices)
Statistical comparison of the 3 measurements (baseline, FiO2 50%, FiO295%) for each device
Measured: one year (end of the recrutement period)
Secondary outcomes (1)
agreement between the noninvasive methods of measurement of hemoglobin and the laboratory analysis
Statistical comparison of the 2 devices
Measured: one year (end of the recrutement period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654913
- Sponsor's protocol ID
- 2012/16
- Other IDs
- 2012-A00416-37
- Acronym
- Hb-O2
- Status last verified
- Oct 2016
- First submitted
- 16 Jul 2012
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Gayat E, Aulagnier J, Matthieu E, Boisson M, Fischler M. Non-invasive measurement of hemoglobin: assessment of two different point-of-care technologies. PLoS One. 2012;7(1):e30065. doi: 10.1371/journal.pone.0030065. Epub 2012 Jan 6.
PubMed 22238693Gayat E, Bodin A, Fischler M. Instability in non-invasive haemoglobin measurement: a possible influence of oxygen administration. Acta Anaesthesiol Scand. 2011 Aug;55(7):902. doi: 10.1111/j.1399-6576.2011.02469.x. Epub 2011 Jun 9. No abstract available.
PubMed 21658016Gayat E, Imbert N, Roujansky A, Lemasle L, Fischler M. Influence of Fraction of Inspired Oxygen on Noninvasive Hemoglobin Measurement: Parallel Assessment of 2 Monitors. Anesth Analg. 2017 Jun;124(6):1820-1823. doi: 10.1213/ANE.0000000000001783.
PubMed 28221201
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Inspired Oxygen Fraction on the Noninvasive Measurement of Hemoglobin Using Two Different Devices (Namely Pronto 7 and NBM-200)
- ClinicalTrials.gov ID
- NCT01654913
- Acronym / sponsor ID
- Hb-O2 / 2012/16
- Conditions
- Anesthesia
- Keywords
- hemoglobin determination, oxygen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 1 Aug 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.
This study examines the effect of oxygen supplementation on the non-invasive measurement of hemoglobin.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgical patients | Experimental | Device: hemoglobin measurementpatients studied just before induction of anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients scheduled for a potentially hemorrhagic surgical procedure
Key exclusion criteria (2 listed)
- anomaly (malformation, infection, swelling, irritation, ulceration, degenerative changes or significant edema) of the fingers,
- tremors.
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 |
|---|---|---|
| hemoglobin measurementNon invasive hemoglobin measurements (Pronto 7 device and NBM-200 device)will be made with : * at baseline (simultaneous blood sample for a laboratory measurement of hemoglobin), * with the patient breathing oxygen via a face-mask (FiO2 50 ± 5%), * with the patient breathing oxygen via a face-mask (FiO2 90 ± 5%) (simultaneous blood sample for a laboratory measurement of hemoglobin). | Device | surgical patients |
Primary outcome
influence of the inspired oxygen fraction on the noninvasive measurement of hemoglobin (Pronto 7 and NBM-200 devices)
Time frame: one year (end of the recrutement period)
Statistical comparison of the 3 measurements (baseline, FiO2 50%, FiO295%) for each device
1 secondary outcome
agreement between the noninvasive methods of measurement of hemoglobin and the laboratory analysis
Time frame: one year (end of the recrutement period)
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 31 Oct 2016.
- Background: PubMed 22238693Gayat E, Aulagnier J, Matthieu E, Boisson M, Fischler M. Non-invasive measurement of hemoglobin: assessment of two different point-of-care technologies. PLoS One. 2012;7(1):e30065. doi: 10.1371/journal.pone.0030065. Epub 2012 Jan 6.
- Background: PubMed 21658016Gayat E, Bodin A, Fischler M. Instability in non-invasive haemoglobin measurement: a possible influence of oxygen administration. Acta Anaesthesiol Scand. 2011 Aug;55(7):902. doi: 10.1111/j.1399-6576.2011.02469.x. Epub 2011 Jun 9. No abstract available.
- Derived from this study: PubMed 28221201Gayat E, Imbert N, Roujansky A, Lemasle L, Fischler M. Influence of Fraction of Inspired Oxygen on Noninvasive Hemoglobin Measurement: Parallel Assessment of 2 Monitors. Anesth Analg. 2017 Jun;124(6):1820-1823. doi: 10.1213/ANE.0000000000001783.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hemoglobin measurement in people with Anesthesia, run by Hopital Foch at 2 sites in 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 1 inclusion and 2 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 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
influence of the inspired oxygen fraction on the noninvasive measurement of hemoglobin (Pronto 7 and NBM-200 devices) (time frame: one year (end of the recrutement period)). 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 NCT01654913, which also lists 3 linked publications.
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 31 Oct 2016.