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

NCT ID: NCT07037784

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-09-30

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Continuous monitoring of vital constants with OXYFLEX® biosensor.

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

HIA Ste Anne

Toulon, Var, France

Countries

France

Facility Contacts

Quentin Mathais, MD

Role: primary

quentin.mathais@intradef.gouv.fr

04 83 16 22 05 ext. +33

Other Identifiers

2024-CHITS-012

Identifier Type: -

Identifier Source: org_study_id