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The purpose of this study is to use the OXYFLEX® device in real care conditions during the hospital management of a population of patients from various hospital services. These services include patients from the severe trauma pathway, intensive care, the polyvalent intensive care unit, and the operating room. The objective is to assess the reliability of the data collected by the OXYFLEX® biosensor compared to those obtained from standard monitoring used in these different services and conditions.
The OXYFLEX® device from the Tecmoled company is a non-invasive biosensor device that allows for continuous monitoring of certain vital signs (heart rate, respiratory rate, etc.) The objectif of this research is to use this device in real care conditions during the hospital management of a patient in severe trauma care, or during anesthesia or hospitalization in the intesive care unit, by comparing the data collected by the OXYFLEX® biosensor with that obtained from standard monitoring.
Continuous multiparametric monitoring is only practiced in hospitals in intensive care units. Physiological parameters in conventional units are measured intermittently every 6 to 8 hours by the paramedical team. Studies have proven the usefulness of continuous monitoring in conventional services to reduce emergency admissions to intensive care and promote earlier intra-hospital emergency team intervention. These continuous monitoring systems, thanks to advances in technology through photoplethysmography, are becoming more affordable, miniaturized, and efficient through biosensors.
The interest in these biosensors has already been demonstrated in regular clinical practice, particularly at the Hôpital Nationale d'Instruction des Armées Sainte Anne (Guardian device), especially when coupled with alert scoring. The new OXYFLEX® biosensor, developed by the company Tecmoled, is based on a non-invasive technique of photoplethysmography, using a sensor placed on the patient's forehead with a headband. It collects pulse oxygen saturation, respiratory rate, heart rate, skin temperature, and head movements through accelerometry. It can also estimate hemoglobin concentration.
The innovative and interesting elements of this biosensor are:
In the current research, have been included:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients managed in anesthesia, rehabilitation/instensive care unit and traumatology services. | Experimental | Demonstrate the relevance of the data collected from patients treated in different hospital departments, including critical emergencies, intensive care, general intensive care units, and the operating room. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous monitoring of vital constants with OXYFLEX® biosensor. | Other | The comparison of physiological data (heart rate, respiratory rate, temperature, pulse oxygen saturation, hemoglobin levels) collected by the OXYFLEX® biosensor with those obtained through standard monitoring over a maximum duration of 10 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| heart rate measurement | The data collected by the OXYFLEX biosensor will be compared to data from standard monitoring using concordance tests, such as the Bland-Altman test, the Intraclass Correlation Coefficient (ICC), and the mean of absolute errors. These analyses will allow for the evaluation of the accuracy and reproducibility of the measurements taken with the OXYFLEX biosensor. | for a maximum of 10 hours |
| respiratory rate measurement | The data collected by the OXYFLEX® biosensor will be compared to data from standard monitoring using concordance tests, such as the Bland-Altman test, the Intraclass Correlation Coefficient (ICC), and the mean of absolute errors. These analyses will allow for the evaluation of the accuracy and reproducibility of the measurements taken with the OXYFLEX® biosensor. | for a maximum of 10 hours |
| temperature measurement | The data collected by the OXYFLEX® biosensor will be compared to data from standard monitoring using concordance tests, such as the Bland-Altman test, the Intraclass Correlation Coefficient (ICC), and the mean of absolute errors. These analyses will allow for the evaluation of the accuracy and reproducibility of the measurements taken with the OXYFLEX® biosensor. | for a maximum of 10 hours |
| pulse oxygen saturation measurement | The data collected by the OXYFLEX® biosensor will be compared to data from standard monitoring using concordance tests, such as the Bland-Altman test, the Intraclass Correlation Coefficient (ICC), and the mean of absolute errors. These analyses will allow for the evaluation of the accuracy and reproducibility of the measurements taken with the OXYFLEX® biosensor. | for a maximum of 10 hours |
| hemoglobin measurement | The data collected by the OXYFLEX® biosensor will be compared to data from standard monitoring using concordance tests, such as the Bland-Altman test, the Intraclass Correlation Coefficient (ICC), and the mean of absolute errors. These analyses will allow for the evaluation of the accuracy and reproducibility of the measurements taken with the OXYFLEX® biosensor. |
| Measure | Description | Time Frame |
|---|---|---|
| Conduct a clinical relevance analysis of the measurements collected by the OXYFLEX® biosensor | The values of blood pressure will be presented as descriptive statistics (mean ± standard deviation, median, and interquartile range if necessary), but no formal statistical analysis is planned at this stage, as the objective is purely exploratory and descriptive. | for a maximum of 10 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HIA Ste Anne | Toulon | Var | 83000 | France |
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| for a maximum of 10 hours |
| Evaluate the data loss rate measured by the OXYFLEX®biosensor, based on the percentage of missing data for each parameter, in relation to the number of expected observations (per minute and/or per hour) over the total monitoring duration. | The analysis of data loss will be based on the calculation of the percentage of missing data for each parameter, taking into account the number of observations expected to be collected per minute and the total duration of monitoring. The duration of each data loss will also be categorized (<5min, 5-14min; 15-60, 1-4 hours, >4 hours). The value of the blood pressure measured during the 10 hours of follow-up of the research will also be collected and made available for the OXYFLEX® algorithm. | for a maximum of 10 hours |
| Investigate the factors impacting the accuracy of measurements and the relevance of data collected by the OXYFLEX®biosensor | Subgroup analysis of the validity of the collected data, their clinical relevance, and the technical performance of the sensor based on parameters that may alter or bias the measurements. | for a maximum of 10 hours |