DYS-FEREA
Facial Infrared Thermal Imaging for Continuous Contact-less Respiratory Distress Monitoring in Mechanically Ventilated Patients
Sponsor study identifier
observational
85
1 country
1
Study Start
July 20, 2023
Actual (reported)Primary Completion
November 13, 2025
Actual (reported)Study Completion
November 13, 2025
Actual (reported)Critically ill patients are exposed to many sources of discomfort and traumatic experiences, especially if they require invasive mechanical ventilation (IMV). Dyspnea, or sensation of "not getting enough air - suffocation" is the most common and distressing symptom experienced by IMV patients, far more unpleasant than pain. But, contrarily to pain, dyspnea has received only little attention and is still markedly under-recognized in IMV patients. Moreover, given the deleterious short- and long-terms consequences of letting IMV patients with dyspnea, its assessment and treatment figures among the main next great cause in critical healthcare. However, dyspnea assessment in IMV patients is a challenge since many of them cannot express their suffering (e.g. sedative drugs, mouth tubes). Dyspnea observation scales (DOS) are promising alternatives that allow to strongly suspecting dyspnea. These scales encompass the dyspnea multidimensionality assessing the respiratory drive (respiratory rate, excessive use neck muscle, nasal flaring), neurovegetative signs (heart rate) and emotions (fearful face). DOS allows calculation of scores strongly correlated with dyspnea in IMV communicative patients and responsive to dyspnea treatment even in noncommunicative ones. However these scales (1) require human resources, (2) still elicit caregivers' subjectivity (fearful face), and (3) are discontinuous, whereas dyspnea is unpredictable, and thus may lead to false appreciation of clinical deterioration. Thus there is an urgent unmet need for technology-enhanced clinical surveillance tools that reliably detect dyspnea in IMV patients and tailor its relief. Infrared thermal imaging (IRTI) offers a unique opportunity to automatically and continuously compute DOS. Indeed, it has been demonstrated as reliable to measure heart and respiratory rate in patients and detect facial expressions even during surgical intervention. The study goal is to prove the concept that IRTI camera device is feasible and reliable to strongly suspect dyspnea, based on the calculation of DOS including heart and respiratory rate, facial expression of fear, and activation of Alae nasi muscle, in IMV patients experiencing an asphyxial threat during a spontaneous breathing trial. The second study goal is to assess the performance of of this multidimensional video taped monitoring to predict the outcome of the spontaneous breathing trial. This project deals with the perspective that artificial intelligence and the development of autonomous patient-machine interfaces will give access to patients' emotions by the analysis of behaviors including facial expressions, in order to improve comfort and reduce traumatic memories of the ICU stay.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 13, 2025
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 6, 2021
Actual (reported)December 20, 2021
Actual (reported)July 20, 2023
Actual (reported)November 13, 2025
Actual (reported)November 13, 2025
Actual (reported)Characterize facial expressions during a spontaneous breathing trial using the Facial Action Coding System
Standard classification of facial expression
during the spontaneous breathing trial
Test performances of machine learning algorithms to detect FACS action units
during the spontaneous breathing trial
Test performances of machine learning algorithms to predict the outcome of the spontaneous breathing trial
during the spontaneous breathing trial
The visible and infrared cameras will be positioned in front of the patient (150 cm from the patient's face). EMG electrodes will also be placed on the wings of the nose and the parasternal intercostal muscles. The pressure and flow sensors will finally be positioned at the level of the airways. EMG, respiratory and video recording will begin 15 minutes before the start of the ventilatory weaning trial. Just before the weaning test, a measurement of dyspnea will be carried out. After 15 minutes of "baseline" recording, patients will be placed in a ventilatory bondage test. Dyspnea will be measured every 5 minutes during the weaning test. After 30 minutes of testing, the ventilatory weaning test is stopped. Patients will then be placed on ventilatory assistance with the same parameters used before the weaning test. An additional 15-minute recording after the end of the ventilatory weaning test will also be made. The recording will therefore last 1 hour in total
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Intensive care patients under invasive mechanical ventilation, deemed ready to perform a ventilatory weaning test.
Service de Médecine Intensive - Réanimation du département R3S, GHU APHP - Sorbonne Université, Site Pitié-Salpêtrière
Paris, Paris, 75013, France
Maxens DECAVELE, MD
Assistance Publique - Hôpitaux de Paris
85 participants (actual enrollment reported by the registry).
First Submitted
December 6, 2021
First Posted
December 20, 2021
Study Start
July 20, 2023
Actual (reported)Estimate the heart and breathing frequencies from the infrared thermal imaging of the face
during the spontaneous breathing trial
Contact the study team to confirm eligibility.
Primary Completion
November 13, 2025
Actual (reported)Study Completion
November 13, 2025
Actual (reported)Last Updated
April 2, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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