Monitoring of Patient Physiological Parameters in Real Life Using OXYFLEX® Biosensors Versus Stan… (NCT07037784) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Monitoring of Patient Physiological Parameters in Real Life Using OXYFLEX® Biosensors Versus Standard Monitoring
France102 participantsStarted 2026-06
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
heart rate measurement
Timeframe: for a maximum of 10 hours
2
respiratory rate measurement
Timeframe: for a maximum of 10 hours
3
temperature measurement
Timeframe: for a maximum of 10 hours
4
pulse oxygen saturation measurement
Timeframe: for a maximum of 10 hours
5
hemoglobin measurement
Timeframe: for a maximum of 10 hours
Trial details
NCT IDNCT07037784
SponsorCentre Hospitalier Intercommunal de Toulon La Seyne sur Mer