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.
Adult patient (≥ 18 years old);
in severe traum pathway in the emergency services department
or in the operating room for a general anesthesia procedur or locoregional anesthesia planned for a surgical duration grater than 2 hours
or admitted to intesive care/ general intensive care units.
Opposition from the patient or their family to participate in the research ;
Pregnant, parturient or breastfeeding woman ;
Patient under judical protection (guardianship, curatorship …) or legal safeguarding ;
Inability to wear the headband and the sensor (in particular : intracranial neurosurgery, othorhinolaryngology or maxillofacial surgery, debilitating trauma to the head or face …) ;
Single group
Continuous monitoring of vital constants with OXYFLEX® biosensor.
Other interventionThe 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.
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.
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.
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.
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.
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.
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.
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.
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