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Non-invasive Tool for Measuring Hemoglobin in Severe Trauma Patients in the ED (HbOxymeter)

Primary Purpose

Trauma

Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Hb Oxymeter
Sponsored by
Hôpital Universitaire Sahloul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Trauma

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Severe trauma patients
  • Patients having benefited from a blood sample to measure hemoglobin.

Exclusion Criteria:

  • Patients less than 3 years old.

Sites / Locations

  • HU Sahloul, sousse, Tunisia
  • Riadh Boukef

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hb Oxymeter

Arm Description

Hb mesurment

Outcomes

Primary Outcome Measures

Accuracy
The accuracy of Hb Oxymeter
the impact Hb Oxymeter
the impact Hb Oxymeter

Secondary Outcome Measures

Full Information

First Posted
May 28, 2021
Last Updated
July 26, 2021
Sponsor
Hôpital Universitaire Sahloul
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1. Study Identification

Unique Protocol Identification Number
NCT04988711
Brief Title
Non-invasive Tool for Measuring Hemoglobin in Severe Trauma Patients in the ED
Acronym
HbOxymeter
Official Title
Evaluation of the Reliability of a Non-invasive Tool for Measuring Hemoglobin in Severe Trauma Patients in the Emergency Room
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital Universitaire Sahloul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
descriptive
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hb Oxymeter
Arm Type
Experimental
Arm Description
Hb mesurment
Intervention Type
Diagnostic Test
Intervention Name(s)
Hb Oxymeter
Intervention Description
Measurement of Hb Oximeter
Primary Outcome Measure Information:
Title
Accuracy
Description
The accuracy of Hb Oxymeter
Time Frame
during the intervention
Title
the impact Hb Oxymeter
Description
the impact Hb Oxymeter
Time Frame
during the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Severe trauma patients Patients having benefited from a blood sample to measure hemoglobin. Exclusion Criteria: Patients less than 3 years old.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riadh Boukef, professor
Organizational Affiliation
CHU Sahloul, Sousse, Tunisia
Official's Role
Principal Investigator
Facility Information:
Facility Name
HU Sahloul, sousse, Tunisia
City
Sousse
State/Province
Itinéraire Ceinture Cité Sahloul
ZIP/Postal Code
4054
Country
Tunisia
Facility Name
Riadh Boukef
City
Sahloul
State/Province
Sousse
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
all data will be presented in the article publication

Learn more about this trial

Non-invasive Tool for Measuring Hemoglobin in Severe Trauma Patients in the ED

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