Monitoring of Physiological Parameters in Real Life in Patients Managed in Anesthesia, Rehabilitation/Intensive Care Unit and Traumatology Services, Using OXYFLEX® Biosensors Versus Standard Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- heart rate measurement
研究概览
简要总结
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.
详细描述
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:
- The placement on the patient's forehead, an area particularly rich in capillaries allowing for a quality signal even under pathological conditions (hypothermia, vasoconstriction).
- The number of monitored parameters, with technology continuously evolving and the future addition of new parameters (estimation of blood pressure).
- Miniaturization facilitating its use. The purpose of this research is to use this biosensor in real life to integrate it in the medium term into an early warning solution in various hospital departments (surgery department; emergency room...); and in the longer term within a project for monitoring and surveillance assisted by Artificial Intelligence in a military context, at the front.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient (≥ 18 years old);
- •Patient taken care of :
- •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.
排除标准
- •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 …) ;
- •Any other reason that, in the investigator's opinion, could interfere with the evaluation of the study objectives.
研究组 & 干预措施
Patients managed in anesthesia, rehabilitation/instensive care unit and traumatology services.
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.
干预措施: Continuous monitoring of vital constants with OXYFLEX® biosensor. (Other)
结局指标
主要结局
heart rate measurement
时间窗: for a maximum of 10 hours
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
时间窗: for a maximum of 10 hours
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
时间窗: for a maximum of 10 hours
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
时间窗: for a maximum of 10 hours
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.
hemoglobin measurement
时间窗: for a maximum of 10 hours
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.
次要结局
- Conduct a clinical relevance analysis of the measurements collected by the OXYFLEX® biosensor(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.(for a maximum of 10 hours)
- Investigate the factors impacting the accuracy of measurements and the relevance of data collected by the OXYFLEX®biosensor(for a maximum of 10 hours)
