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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Tunisia

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 groups in NCT04988711
Study groupRoleWhat they receive
Hb OxymeterExperimentalHb mesurment
Receives: Diagnostic Test: Hb Oxymeter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy

    The accuracy of Hb Oxymeter

    Measured: during the intervention

  2. 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.

  1. First posted3 Aug 2021
  2. Study start1 Aug 2017
  3. Primary completion30 Apr 2021
  4. Study completion1 May 2021

Resources

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)
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

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.

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