Dyspnea Invasive Mechanical Ventilation-associatedDYS-FEREANCT05163275
Dyspnea Facial Recognition During Weaning
An observational study of Dyspnea Invasive Mechanical Ventilation-associated, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Dyspnea Invasive Mechanical Ventilation-associated
- What is being tested?
- Video recording and EMG
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jul 2023to 13 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intensive care patients under invasive mechanical ventilation, deemed ready to perform a ventilatory weaning test.
Who may be able to join
- Invasive mechanical ventilation> 48h
- Deemed ready to perform a spontaneous breathing trial, according to current guidelines (readiness-to-wean criteria)
- Decision to perform a spontaneous breathing trial
- Patients or proxy who do not object to participation in the study
Who cannot join
- Age < 18
- Pregnancy
- Richmond Analgesia And Sedation scale < 2 or > 2
- Patient under legal protection
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Intensive - Réanimation du département R3S, GHU APHP - Sorbonne Université, Site Pitié-Salpêtrière
Paris, Paris, 75013
About this study
Official title: Facial Infrared Thermal Imaging for Continuous Contact-less Respiratory Distress Monitoring in Mechanically Ventilated Patients
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.
Read more
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.
Read the detailed description
Scientific background and rational of the project Dyspnea, defined as "suffocation or not getting enough air" is the most common (50% of patients) and debilitating symptom experienced by patients receiving invasive mechanical ventilation (IMV). Dyspnea is a noxious sensation but is far more unpleasant than pain because it is constantly associated with anxiety (up to unquenchable fear of dying), and because patients cannot escape from their source of dyspnea, which also connect them to life (ventilator). The inability to verbally communicate with caregivers reinforces the sense of loss of control and fear.
Apart form generating immediate suffering, dyspnea is associated with negative ventilator weaning outcomes and plays a major role in the genesis of post traumatic stress disorders which concerns almost 20% of IMV patients. This should make it a major preoccupation for ICU physicians and nurses whose mission is to relieve symptoms.
However, very little attention is given to dyspnea in IMV patients, which remains markedly under-recognized. Besides this caregivers' unawareness it might be even more challenging to detect dyspnea in IMV patients, since at least one-third are unable to communicate with their caregivers (sedative drugs, delirium, endotracheal tube). However, the inability to communicate in no way negates the possibility that an individual is experiencing dyspnea. Noncommunicative IMV patients are exposed to the same risk factors of dyspnea as communicative patients and should rather be considered as a vulnerable population at high risk for misdiagnosis and under treatment of dyspnea.
In view of the listed issues, the use of a medical solution to robustly suspect dyspnea without eliciting patient cooperation is of utmost importance. It will warn caregiver to the possibility of dyspnea in a patient and will prompt patient/caregiver interactions aiming at relieve this discomfort, such as adjusting ventilator settings.
Dyspnea observation scales (DOS) do not require patient's self-report and are promising alternatives that overcome this "dyspnea invisibility". These DOS encompass the dyspnea multidimensionality and are based on physiological and emotional modification the most correlated to dyspnea including tachycardia (neurovegetative sign), facial expression of fear (emotional consequence) and observational signs of respiratory drive such as breathing frequency, excessive use extradiaphragmatic inspiratory muscle (neck or Alae nasi muscle). These DOS allows calculation of scores strongly correlated with dyspnea in communicative IMV patients and responsive to dyspnea treatment in noncommunicative ones.
Benefits and limits of dyspnea observation scales The main advantage of these multidimensional scales is, exactly, to limit observer subjectivity where heuristic reasoning (intuition) and medical experience have failed. Such numerical transformation of clinical variables allows statistics application for clinical research and monitoring of symptoms evolution to tailor therapeutic interventions.
However, DOS contain several limits in routine. Firstly, their clinical use requires human medical resources and time. Secondly, inter-observer agreement between physicians and nurses is moderate and heterogeneous among items, being at its lowest for "facial expression of fear" traducing substantial observer's subjectivity involvement that may exactly limits the specific advantages of such tools. Thirdly, these scales can, by nature, only provide discontinuous measurements" whereas dyspnea is by nature labile. As a result, the use of DOS, even if it constitutes an improvement over an absence of detection, cannot guarantee an efficient monitoring of clinical deterioration.
Infrared thermography: toward Autonomous Non-contact Patient Monitoring Infrared thermal imaging (IRTI) offers a unique opportunity to automatically and continuously compute DOS. Indeed, IRTI is known to give access to respiratory rate through cyclic detection of warm expired air at the mouth/nose or endotracheal tube, heart rate through cyclic warming of the face related to the cardiac pulse, and facial expression through algorithm of facial expressions recognition according to the Facial Action Coding System (FACS). Main advantages of IRTI compared to standard Red/Green/Blue signal, is its ability to detect respiration from the face and its operation even in total darkness providing accurate monitoring of patients also during night, in the ICU setting.
In other hand, current contact methods of cardiorespiratory monitoring often cause discomfort or soreness (e.g. undesirable skin irritation, wire discomfort during sleep) and contact surface electrodes detach easily from the skin, especially in dyspneic patients (agitated and sweaty) and depend on patients' morphology (e.g. obese patients or thoracic deformation). For all these reasons, IRTI appears as an unobtrusive providential solution combining all these multidimensional measurements in one single technological camera device, and restoring the possibility to continuously suspect dyspnea in IMV patients, without elicit their conscious cooperation.
Preliminary data of facial expressions of dyspnea If the detection of respiratory and heart rate may appear obvious and are well validated but this is not necessarily the case for facial expression. Here, the investigators planned to focus on the detection of the FACS Action Units (AU) 1 (Inner brow raiser), 2 (outer brow raiser), 5 (Upper lid raiser) and 38 (nasal flaring) Excessive use of neck muscle is a classical "respiratory drive - item" of the DOS, but is not accessible with a face focused camera and could be replace by the cyclic contraction of the Alae Nasi muscle (nasal flaring). Indeed nasal flaring is listed as item of the classical DOS, are well known as an indicator of respiratory drive and have been shown by the investigator group to strongly correlate with both experimental and in clinical ICU dyspnea.
Facial expression of fear is also listed as item of classical DOS, and is well described by the concomitant onset of AU1, 2 and 5. The investigator group has recently confirmed that AU1, 2, 5 are the facial expressions the most prevalent in experimentally induced dyspnea among 23 healthy volunteers. In this data setup, AU38 had a strong discriminant value between pain and dyspnea.
- Being tested
- Video recording and EMG
- Keywords
- Dyspnea, Respiratory distress, Artificial intelligence, Spontaneous breathing trial, Autonomous monitoring, Critical care, Intensive care unit, Respiratory suffering, Facial expression recognition, Video
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video recording and EMGDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Diagnostic Test: Video recording and EMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize facial expressions during a spontaneous breathing trial using the Facial Action Coding System
Standard classification of facial expression
Measured: during the spontaneous breathing trial
Secondary outcomes (3)
Test performances of machine learning algorithms to detect FACS action units
machine learning algorithms trained on the video database obtained from patients undergoing a spontaneous breathing trial
Measured: during the spontaneous breathing trial
Test performances of machine learning algorithms to predict the outcome of the spontaneous breathing trial
machine learning algorithms (deep learning) trained on the video database obtained from patients undergoing a spontaneous breathing trial
Measured: during the spontaneous breathing trial
Estimate the heart and breathing frequencies from the infrared thermal imaging of the face
estimation possible from the respiratory temperature variation in the endotracheal tube (respiratory rate) and the pulse temperature variation of the face (heart rate)
Measured: during the spontaneous breathing trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start20 Jul 2023
- Primary completion13 Nov 2025
- Study completion13 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyspnea Invasive Mechanical Ventilation-associatedStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxens DECAVELE, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163275
- Sponsor's protocol ID
- APHP211371
- Acronym
- DYS-FEREA
- Status last verified
- Apr 2026
- First submitted
- 6 Dec 2021
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facial Infrared Thermal Imaging for Continuous Contact-less Respiratory Distress Monitoring in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT05163275
- Acronym / sponsor ID
- DYS-FEREA / APHP211371
- Keywords
- Dyspnea, Respiratory distress, Artificial intelligence, Spontaneous breathing trial, Autonomous monitoring, Critical care, Intensive care unit, Respiratory suffering
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 13 Nov 2025 (actual)
- Study completion
- 13 Nov 2025 (actual)
- First posted
- 20 Dec 2021 (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.
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.
Detailed description
Scientific background and rational of the project Dyspnea, defined as "suffocation or not getting enough air" is the most common (50% of patients) and debilitating symptom experienced by patients receiving invasive mechanical ventilation (IMV). Dyspnea is a noxious sensation but is far more unpleasant than pain because it is constantly associated with anxiety (up to unquenchable fear of dying), and because patients cannot escape from their source of dyspnea, which also connect them to life (ventilator). The inability to verbally communicate with caregivers reinforces the sense of loss of control and fear.
Apart form generating immediate suffering, dyspnea is associated with negative ventilator weaning outcomes and plays a major role in the genesis of post traumatic stress disorders which concerns almost 20% of IMV patients. This should make it a major preoccupation for ICU physicians and nurses whose mission is to relieve symptoms.
However, very little attention is given to dyspnea in IMV patients, which remains markedly under-recognized. Besides this caregivers' unawareness it might be even more challenging to detect dyspnea in IMV patients, since at least one-third are unable to communicate with their caregivers (sedative drugs, delirium, endotracheal tube). However, the inability to communicate in no way negates the possibility that an individual is experiencing dyspnea. Noncommunicative IMV patients are exposed to the same risk factors of dyspnea as communicative patients and should rather be considered as a vulnerable population at high risk for misdiagnosis and under treatment of dyspnea.
In view of the listed issues, the use of a medical solution to robustly suspect dyspnea without eliciting patient cooperation is of utmost importance. It will warn caregiver to the possibility of dyspnea in a patient and will prompt patient/caregiver interactions aiming at relieve this discomfort, such as adjusting ventilator settings.
Dyspnea observation scales (DOS) do not require patient's self-report and are promising alternatives that overcome this "dyspnea invisibility". These DOS encompass the dyspnea multidimensionality and are based on physiological and emotional modification the most correlated to dyspnea including tachycardia (neurovegetative sign), facial expression of fear (emotional consequence) and observational signs of respiratory drive such as breathing frequency, excessive use extradiaphragmatic inspiratory muscle (neck or Alae nasi muscle). These DOS allows calculation of scores strongly correlated with dyspnea in communicative IMV patients and responsive to dyspnea treatment in noncommunicative ones.
Benefits and limits of dyspnea observation scales The main advantage of these multidimensional scales is, exactly, to limit observer subjectivity where heuristic reasoning (intuition) and medical experience have failed. Such numerical transformation of clinical variables allows statistics application for clinical research and monitoring of symptoms evolution to tailor therapeutic interventions.
However, DOS contain several limits in routine. Firstly, their clinical use requires human medical resources and time. Secondly, inter-observer agreement between physicians and nurses is moderate and heterogeneous among items, being at its lowest for "facial expression of fear" traducing substantial observer's subjectivity involvement that may exactly limits the specific advantages of such tools. Thirdly, these scales can, by nature, only provide discontinuous measurements" whereas dyspnea is by nature labile. As a result, the use of DOS, even if it constitutes an improvement over an absence of detection, cannot guarantee an efficient monitoring of clinical deterioration.
Infrared thermography: toward Autonomous Non-contact Patient Monitoring Infrared thermal imaging (IRTI) offers a unique opportunity to automatically and continuously compute DOS. Indeed, IRTI is known to give access to respiratory rate through cyclic detection of warm expired air at the mouth/nose or endotracheal tube, heart rate through cyclic warming of the face related to the cardiac pulse, and facial expression through algorithm of facial expressions recognition according to the Facial Action Coding System (FACS). Main advantages of IRTI compared to standard Red/Green/Blue signal, is its ability to detect respiration from the face and its operation even in total darkness providing accurate monitoring of patients also during night, in the ICU setting.
In other hand, current contact methods of cardiorespiratory monitoring often cause discomfort or soreness (e.g. undesirable skin irritation, wire discomfort during sleep) and contact surface electrodes detach easily from the skin, especially in dyspneic patients (agitated and sweaty) and depend on patients' morphology (e.g. obese patients or thoracic deformation). For all these reasons, IRTI appears as an unobtrusive providential solution combining all these multidimensional measurements in one single technological camera device, and restoring the possibility to continuously suspect dyspnea in IMV patients, without elicit their conscious cooperation.
Preliminary data of facial expressions of dyspnea If the detection of respiratory and heart rate may appear obvious and are well validated but this is not necessarily the case for facial expression. Here, the investigators planned to focus on the detection of the FACS Action Units (AU) 1 (Inner brow raiser), 2 (outer brow raiser), 5 (Upper lid raiser) and 38 (nasal flaring) Excessive use of neck muscle is a classical "respiratory drive - item" of the DOS, but is not accessible with a face focused camera and could be replace by the cyclic contraction of the Alae Nasi muscle (nasal flaring). Indeed nasal flaring is listed as item of the classical DOS, are well known as an indicator of respiratory drive and have been shown by the investigator group to strongly correlate with both experimental and in clinical ICU dyspnea.
Facial expression of fear is also listed as item of classical DOS, and is well described by the concomitant onset of AU1, 2 and 5. The investigator group has recently confirmed that AU1, 2, 5 are the facial expressions the most prevalent in experimentally induced dyspnea among 23 healthy volunteers. In this data setup, AU38 had a strong discriminant value between pain and dyspnea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Video recording and EMG |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care patients under invasive mechanical ventilation, deemed ready to perform a ventilatory weaning test.
Key inclusion criteria (4 listed)
- Invasive mechanical ventilation> 48h
- Deemed ready to perform a spontaneous breathing trial, according to current guidelines (readiness-to-wean criteria)
- Decision to perform a spontaneous breathing trial
- Patients or proxy who do not object to participation in the study
Key exclusion criteria (4 listed)
- Age < 18
- Pregnancy
- Richmond Analgesia And Sedation scale < 2 or > 2
- Patient under legal protection
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 |
|---|---|---|
| Video recording and EMGThe 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 | Diagnostic test | Patients |
Primary outcome
Characterize facial expressions during a spontaneous breathing trial using the Facial Action Coding System
Time frame: during the spontaneous breathing trial
Standard classification of facial expression
3 secondary outcomes
Test performances of machine learning algorithms to detect FACS action units
Time frame: during the spontaneous breathing trial
Test performances of machine learning algorithms to predict the outcome of the spontaneous breathing trial
Time frame: during the spontaneous breathing trial
Estimate the heart and breathing frequencies from the infrared thermal imaging of the face
Time frame: during the spontaneous breathing trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
Maxens DECAVELE, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea Invasive Mechanical Ventilation-associated, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 2 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize facial expressions during a spontaneous breathing trial using the Facial Action Coding System (time frame: during the spontaneous breathing trial). 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 2 Apr 2026.