TraumaHbOxymeterNCT04988711
Non-invasive Tool for Measuring Hemoglobin in Severe Trauma Patients in the ED
A study testing Hb Oxymeter in people with Trauma, run by Hôpital Universitaire Sahloul at 2 sites in Tunisia.
Trial summary
The development of miniaturized analytical technologies has facilitated the gradual decentralization of part of the laboratory examinations to the patient. In addition, investigators are currently seeing the development of tools for non-invasive measurement of certain biological parameters. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Trauma
- What is being tested?
- Hb Oxymeter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTunisia
- Study dates
- 1 Aug 2017to 1 May 2021
- 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Severe trauma patients
- Patients having benefited from a blood sample to measure hemoglobin.
Who cannot join
- Patients less than 3 years old.
Trial locations and contacts
2 sites in 1 country.
Tunisia2 sites
Riadh Boukef
Sahloul, Sousse Governorate
HU Sahloul, sousse, Tunisia
Sousse, Itinéraire Ceinture Cité Sahloul, 4054
About this study
Official title: Evaluation of the Reliability of a Non-invasive Tool for Measuring Hemoglobin in Severe Trauma Patients in the Emergency Room
The development of miniaturized analytical technologies has facilitated the gradual decentralization of part of the laboratory examinations to the patient.
In addition, investigators are currently seeing the development of tools for non-invasive measurement of certain biological parameters. Thanks to their ease of use, results are obtained almost immediately and with good performance. These "rapid" tests or techniques should, in theory, reduce the time taken to take charge of patients, particularly in emergencies or in critical situations where the therapeutic decision should be as rapid and efficient as possible. These means, by their ease and speed of results, could be associated with the clinical examination of the practitioner to increase his diagnostic performance.
Read the detailed description
It should be remembered that the journey of samples from the emergency room to the central laboratory, then the return of results is broken down into three phases: 1) the pre-analytical phase which includes medical prescription, sampling, request for analysis and delivery to 'at the central laboratory; 2) the analytical phase, specific to the laboratory, and which includes handling the sample and the analysis itself. This stage ends with the provision of the results (computer notification) and 3) the third stage (post analytical) represents the time between the provision of the results, their reading and their interpretation. All of these three phases constitute the recognized prescription-results-treatment time: Therapeutic Turn-around Time (TTAT). The main objective of these revolutionary techniques is to reduce this time or the duration of these three stages.
Several techniques, in particular delocalized biology, have been evaluated and validated in emergencies or even at home. In addition, non-invasive means remain underestimated in terms of relevance and reliability, mainly by lack of evaluation.
These measurement techniques relocated to the patient's bed allow rapid, non-invasive measurement without the need for intravenous access or the need to draw venous, arterial or capillary blood. These non-invasive devices can be portable, inexpensive, easy to use, and offer great benefits especially in emergency departments and pre-hospital settings. The accuracy of these methods is acceptable in the stable ICU patient. But that remains unassessed in an emergency.
Pulse co-oximetry or low perfusion oximetry is one of these technological advances being designed to allow the measurement of hemoglobin in a non-invasive manner. In addition, the automated spectrophotometric detection technique from a blood sample represents the Gold standard for the measurement of hemoglobin and has been recommended for several decades by the International Committee for Standardization in Hematology. This technique, performed in a hematology laboratory, allows precise, reliable and reproducible measurement. However, it requires a blood sample and above all imposes an incompressible delay. This dosage is one of the most prescribed samples in current practice in the emergency room. The possibility of determining the hemoglobin concentration in the patient's bed and non-invasively is a very attractive solution for the emergency physician.
The value of such a technique in trauma pathology seems indisputable. In fact, injuries represent a major problem for public health, representing more than 9% of deaths in the world each year. In particular, post-traumatic hemorrhage is the most common cause of preventable deaths, accounting for 50% of preventable deaths in the first 24 hours after major trauma. Early detection of hypovolaemia due to hemorrhage can be difficult, but essential for the patient's prognosis through an appropriate and adapted transfusion strategy. The hemoglobin dosage is essential for the emergency physician. Therefore, in the hospital setting, there is growing interest in rapid techniques for measuring hemoglobin.
Recently, a new device, Pronto-7, a point-controlled pulse CO-oximeter, has been developed. The Pronto-7 Spot Check Pulse CO-Oximeter has a spectrophotometric sensor (Rainbow DCI) that detects multiple wavelengths of light. The pulse CO-oximetry method discerns the distinctive light absorption characteristics of different hemoglobin species and applies proprietary algorithms to determine hemoglobin levels.
Few studies have investigated the effectiveness of this non-invasive hemoglobin measurement tool in trauma patients. No study in Tunisia has looked at the validation of this tool in terms of reliability, hence the interest of this study.
- Conditions
- Trauma
- Being tested
- Hb Oxymeter
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hb OxymeterDiagnostic test
Measurement of Hb Oximeter
| Study group | Role | What they receive |
|---|---|---|
| Hb Oxymeter | Experimental | Hb mesurment Receives: Diagnostic Test: Hb Oxymeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
The accuracy of Hb Oxymeter
Measured: during the intervention
the impact Hb Oxymeter
the impact Hb Oxymeter
Measured: during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Aug 2017
- Primary completion30 Apr 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies 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
- Model description
- descriptive
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Universitaire Sahloul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riadh Boukef, Hôpital Universitaire Sahloul
- Investigators
- Riadh Boukef, professor, Principal investigator, CHU Sahloul, Sousse, Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988711
- Sponsor's protocol ID
- HbOxymeter
- Acronym
- HbOxymeter
- Status last verified
- Jul 2021
- First submitted
- 28 May 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: all data will be presented in the article publication
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Reliability of a Non-invasive Tool for Measuring Hemoglobin in Severe Trauma Patients in the Emergency Room
- ClinicalTrials.gov ID
- NCT04988711
- Acronym / sponsor ID
- HbOxymeter / HbOxymeter
- Conditions
- Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hôpital Universitaire SahloulUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 3 Aug 2021 (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 development of miniaturized analytical technologies has facilitated the gradual decentralization of part of the laboratory examinations to the patient.
In addition, investigators are currently seeing the development of tools for non-invasive measurement of certain biological parameters. Thanks to their ease of use, results are obtained almost immediately and with good performance. These "rapid" tests or techniques should, in theory, reduce the time taken to take charge of patients, particularly in emergencies or in critical situations where the therapeutic decision should be as rapid and efficient as possible. These means, by their ease and speed of results, could be associated with the clinical examination of the practitioner to increase his diagnostic performance.
Detailed description
It should be remembered that the journey of samples from the emergency room to the central laboratory, then the return of results is broken down into three phases: 1) the pre-analytical phase which includes medical prescription, sampling, request for analysis and delivery to 'at the central laboratory; 2) the analytical phase, specific to the laboratory, and which includes handling the sample and the analysis itself. This stage ends with the provision of the results (computer notification) and 3) the third stage (post analytical) represents the time between the provision of the results, their reading and their interpretation. All of these three phases constitute the recognized prescription-results-treatment time: Therapeutic Turn-around Time (TTAT). The main objective of these revolutionary techniques is to reduce this time or the duration of these three stages.
Several techniques, in particular delocalized biology, have been evaluated and validated in emergencies or even at home. In addition, non-invasive means remain underestimated in terms of relevance and reliability, mainly by lack of evaluation.
These measurement techniques relocated to the patient's bed allow rapid, non-invasive measurement without the need for intravenous access or the need to draw venous, arterial or capillary blood. These non-invasive devices can be portable, inexpensive, easy to use, and offer great benefits especially in emergency departments and pre-hospital settings. The accuracy of these methods is acceptable in the stable ICU patient. But that remains unassessed in an emergency.
Pulse co-oximetry or low perfusion oximetry is one of these technological advances being designed to allow the measurement of hemoglobin in a non-invasive manner. In addition, the automated spectrophotometric detection technique from a blood sample represents the Gold standard for the measurement of hemoglobin and has been recommended for several decades by the International Committee for Standardization in Hematology. This technique, performed in a hematology laboratory, allows precise, reliable and reproducible measurement. However, it requires a blood sample and above all imposes an incompressible delay. This dosage is one of the most prescribed samples in current practice in the emergency room. The possibility of determining the hemoglobin concentration in the patient's bed and non-invasively is a very attractive solution for the emergency physician.
The value of such a technique in trauma pathology seems indisputable. In fact, injuries represent a major problem for public health, representing more than 9% of deaths in the world each year. In particular, post-traumatic hemorrhage is the most common cause of preventable deaths, accounting for 50% of preventable deaths in the first 24 hours after major trauma. Early detection of hypovolaemia due to hemorrhage can be difficult, but essential for the patient's prognosis through an appropriate and adapted transfusion strategy. The hemoglobin dosage is essential for the emergency physician. Therefore, in the hospital setting, there is growing interest in rapid techniques for measuring hemoglobin.
Recently, a new device, Pronto-7, a point-controlled pulse CO-oximeter, has been developed. The Pronto-7 Spot Check Pulse CO-Oximeter has a spectrophotometric sensor (Rainbow DCI) that detects multiple wavelengths of light. The pulse CO-oximetry method discerns the distinctive light absorption characteristics of different hemoglobin species and applies proprietary algorithms to determine hemoglobin levels.
Few studies have investigated the effectiveness of this non-invasive hemoglobin measurement tool in trauma patients. No study in Tunisia has looked at the validation of this tool in terms of reliability, hence the interest of this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- descriptive
| Arm | Type | Receives |
|---|---|---|
| Hb Oxymeter | Experimental | Diagnostic Test: Hb OxymeterHb mesurment |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Severe trauma patients
- Patients having benefited from a blood sample to measure hemoglobin.
Key exclusion criteria (1 listed)
- Patients less than 3 years old.
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 |
|---|---|---|
| Hb OxymeterMeasurement of Hb Oximeter | Diagnostic test | Hb Oxymeter |
Primary outcome
Accuracy
Time frame: during the intervention
The accuracy of Hb Oxymeter
the impact Hb Oxymeter
Time frame: during the intervention
the impact Hb Oxymeter
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 3 Aug 2021.
- Individual participant dataSharing planned: No. all data will be presented in the article publication
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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.
Riadh Boukef, professor principal investigator
CHU Sahloul, Sousse, Tunisia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hb Oxymeter in people with Trauma, run by Hôpital Universitaire Sahloul at 2 sites in Tunisia.
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 3 Aug 2021. 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 Tunisia. 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?
Accuracy (time frame: during the intervention). The study lists 2 primary outcomes in all. 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 3 Aug 2021.