Monitoring of Patient Physiological Parameters in Real Life Using OXYFLEX® Biosensors Versus Standard Monitoring

NCT07037784 | Not Yet Recruiting

• 1 other identifier: 2024-CHITS-012
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Physiological Parameters

Keywords

biosensor; early warning score; real care conditions; traumatology; anesthesia; intensive care

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  for a maximum of 10 hours

Secondary Outcomes (3)

• 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

Study Arms (1)

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.

Other: Continuous monitoring of vital constants with OXYFLEX® biosensor.

Interventions

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.

Patients managed in anesthesia, rehabilitation/instensive care unit and traumatology services.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (1)

HIA Ste Anne

Toulon, Var, 83000, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 26, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)