Physiological ParametersOXYVIVONCT07037784
Monitoring of Patient Physiological Parameters in Real Life Using OXYFLEX® Biosensors Versus Standard Monitoring
A study testing Continuous monitoring of vital constants with OXYFLEX® biosensor. in people with Physiological Parameters, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physiological Parameters
- What is being tested?
- Continuous monitoring of vital constants with OXYFLEX® biosensor.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
HIA Ste Anne
Toulon, Var, 83000
Quentin Mathais, MD, 04 83 16 22 05 ext. +33, quentin.mathais@intradef.gouv.fr
About this study
Official title: 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
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.
Read the detailed description
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.
In the current research, have been included:
- A subgroup of patients treated in the operating room for scheduled surgery, in order to test the sensors under 'ideal' conditions, that is to say, in immobile patients without failure, particularly hemodynamic.
- A subgroup of patients hospitalized in intensive care to test the sensors in more degraded conditions (hemodynamic failure, invasive mechanical ventilation...).
- A subgroup of severely traumatized patients to also test the sensor in a population of patients potentially experiencing hemodynamic failure; and requiring numerous transfers during the patient journey (emergency vital care unit,scan, angiography, operating room, intensive care...).
- Conditions
- Physiological Parameters
- Being tested
- Continuous monitoring of vital constants with OXYFLEX® biosensor.
- Keywords
- biosensor, early warning score, real care conditions, traumatology, anesthesia, intensive care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Continuous monitoring of vital constants with OXYFLEX® biosensor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: for a maximum of 10 hours
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: for a maximum of 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study startJul 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological ParametersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037784
- Sponsor's protocol ID
- 2024-CHITS-012
- Acronym
- OXYVIVO
- Status last verified
- Jul 2026
- First submitted
- 6 Jun 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07037784
- Acronym / sponsor ID
- OXYVIVO / 2024-CHITS-012
- Conditions
- Physiological Parameters
- Keywords
- biosensor, early warning score, real care conditions, traumatology, anesthesia, intensive care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
In the current research, have been included:
- A subgroup of patients treated in the operating room for scheduled surgery, in order to test the sensors under 'ideal' conditions, that is to say, in immobile patients without failure, particularly hemodynamic.
- A subgroup of patients hospitalized in intensive care to test the sensors in more degraded conditions (hemodynamic failure, invasive mechanical ventilation...).
- A subgroup of severely traumatized patients to also test the sensor in a population of patients potentially experiencing hemodynamic failure; and requiring numerous transfers during the patient journey (emergency vital care unit,scan, angiography, operating room, intensive care...).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients managed in anesthesia, rehabilitation/instensive care unit and traumatology services. | Experimental | Other: Continuous monitoring of vital constants with OXYFLEX® biosensor.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous monitoring of vital constants with OXYFLEX® biosensor.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. | Other | Patients managed in anesthesia, rehabilitation/instensive care unit and traumatology services. |
Primary outcome
heart rate measurement
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
Conduct a clinical relevance analysis of the measurements collected by the OXYFLEX® biosensor
Time frame: 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.
Time frame: for a maximum of 10 hours
Investigate the factors impacting the accuracy of measurements and the relevance of data collected by the OXYFLEX®biosensor
Time frame: for a maximum of 10 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous monitoring of vital constants with OXYFLEX® biosensor. in people with Physiological Parameters, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart rate measurement (time frame: for a maximum of 10 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.