Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04988711
Study type Interventional
Source Hôpital Universitaire Sahloul
Contact
Status Completed
Phase N/A
Start date August 1, 2017
Completion date May 1, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT04848376 - Post-Market Clinical Follow-up Study of A-SPINE's Products
Terminated NCT03781817 - Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures Phase 4
Completed NCT04342416 - Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women N/A
Recruiting NCT04856449 - DBT Skills Plus EMDR for BPD and Trauma N/A
Completed NCT04356963 - Adjunct VR Pain Management in Acute Brain Injury N/A
Completed NCT05669313 - The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
Active, not recruiting NCT03622632 - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Recruiting NCT04725721 - Testing FIRST in Youth Outpatient Psychotherapy N/A
Active, not recruiting NCT05530642 - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Not yet recruiting NCT03696563 - FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS N/A
Withdrawn NCT03249129 - Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
Completed NCT02240732 - Surgical Tourniquets and Cerebral Emboli N/A
Completed NCT02227979 - Effects of PURPLE Cry Intervention N/A
Withdrawn NCT01169025 - Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients N/A
Recruiting NCT01812941 - Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients N/A
Completed NCT01475344 - Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC) Phase 1/Phase 2
Completed NCT03112304 - Child STEPS for Youth Mental Health in Maine Sustainability N/A
Completed NCT01210417 - Trauma Heart to Arm Time N/A
Completed NCT01201863 - Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy Phase 4