Acute Respiratory Failure (ARF)MM-ICUNCT07441590
Evaluation of the Clinical and Prognostic Value of Non-invasive Analysis of Mandibular Movements (MM) as a Marker of Inspiratory Effort in the Spontaneously Breathing Intensive Care Patient
A study testing 2 recording phases in people with Acute Respiratory Failure (ARF) and Intensive Care Unit (ICU) Patients, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Evaluate the performance for measuring inspiratory effort of non-invasive mandibular movement analysis compared to the reference technique oesophageal pressure (PES) variation, in ventilated and spontaneously breathing Intensive Care Unity (ICU) patients, during weaning from mechanical ventilation and within 48 hours… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure (ARF), Intensive Care Unit (ICU) Patients, Invasive Mechanical Ventilation
- What is being tested?
- 2 recording phases
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2026to Apr 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 patients (≥ 18 years)
- Admitted to the Intensive Care Unit for acute respiratory failure
- On invasive mechanical ventilation for more than 24 hours with:
- A respiratory rate ≤ 35 breaths/minute;
- Adequate oxygenation, defined as either an oxygen saturation of at least 90% (obtained during ventilation with a fraction of inspired oxygen [FiO2] ≤ 40% and a positive end-expiratory pressure [PEEP] ≤ 8 cm of water) or an arterial partial pressure of oxygen (PaO2) (measured in mmHg) / FiO2 ratio > 150 (obtained during ventilation with a PEEP ≤ 8 cm of water);
- Respiratory muscle capacity allowing for an effective cough;
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- A state of wakefulness, defined as a Richmond Agitation and Sedation Scale (RASS) score of -2 to +1;
- No use of continuous sedation;
- No use of vasopressors (or use of minimal doses).
- At high risk of weaning failure defined by at least one of the following criteria (5):
- Age > 65 years
- A cardiac comorbidity among: systolic dysfunction (ejection fraction ≤45%), permanent atrial fibrillation, or a history of cardiogenic pulmonary edema or myocardial ischemia
- A respiratory comorbidity among: COPD, restrictive lung disease, or obesity hypoventilation syndrome
- Written informed consent obtained from the patient, or in case of incapacity, from the next of kin/trusted person
- Patient covered by social security
Who cannot join
- Absolute contraindication to NIV (patient refusal, undrained pneumothorax, intractable vomiting, upper airway obstruction, upper gastrointestinal bleeding, severe craniofacial trauma)
- Absolute contraindication to nasogastric tube placement (upper gastrointestinal bleeding, epistaxis, skull base trauma)
- Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant woman, parturient woman, breastfeeding mother, person deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8, persons admitted to a health or social establishment for purposes other than research, minors, person subject to a legal protection measure or unable to express their consent).
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
University Hospital Grenoble
Grenoble, Auvergne-Rhône-Alpes, 38043
Florian SIGAUD, 0476768076, fsigaud@chu-grenoble.fr
Roselyne COLLOMB-MURET, 0476767109, rcollombmuret@chu-grenoble.fr
About this study
Evaluate the performance for measuring inspiratory effort of non-invasive mandibular movement analysis compared to the reference technique oesophageal pressure (PES) variation, in ventilated and spontaneously breathing Intensive Care Unity (ICU) patients, during weaning from mechanical ventilation and within 48 hours after extubation.
The investigators hypothesis is that the assessment of respiratory effort by MM analysis could represent a non-invasive and reliable alternative to the measurement of PES in critically ill patients.
Read the detailed description
Acute respiratory failure is the leading cause of ICU admission and is associated with high mortality. In patients with spontaneous breathing, inspiratory effort reflects ventilatory drive, which is frequently altered in critical illness due to the underlying pathology or its management.
Excessive inspiratory effort is associated with failure of non-invasive oxygenation strategies, difficult ventilator weaning, and increased mortality. Clinicians must therefore balance the benefits of maintaining spontaneous ventilation with the principles of protective ventilation to prevent lung injury induced either by the ventilator or by the patient.
The reference method for assessing inspiratory effort is esophageal pressure measurement (ΔPES), an invasive technique that limits routine clinical use. Recent studies suggest that non-invasive monitoring of mandibular movements provides a reliable assessment of respiratory effort.
The investigators hypothesize that analysis of mandibular movements could represent a reliable and non-invasive alternative to esophageal pressure measurement for evaluating respiratory effort in critically ill patients.
- Conditions
- Acute Respiratory Failure (ARF), Intensive Care Unit (ICU) Patients, Invasive Mechanical Ventilation
- Being tested
- 2 recording phases
- Keywords
- intensive care unit, acute respiratory failure, invasive mechanical ventilation, weaning from mechanical ventilation, ventilatory control, Breathing efforts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 recording phasesOther
An initial phase of recordings will be performed without sedation, during invasive mechanical ventilation (spontaneous ventilation with inspiratory support): recording of MM and PES will begin 30 minutes before the start of the weaning trial and will continue for 30 minutes during the trial. These measurements will be taken each day the clinician schedules a weaning trial until extubation. The weaning trial will be conducted according to the department's protocol and under medical supervision.
The second phase will take place during the 48 hours following extubation, with the use of non-invasive ventilation alternating with high-flow humidified oxygen therapy to prevent extubation failure. The esophageal tube will remain in place during this period. The esophageal tube will remain in place. Recording of MM and SEEP will begin 30 minutes before the end of a non-invasive ventilation session and continue for 30 minutes with humidified high-flow oxygen therapy.
| Study group | Role | What they receive |
|---|---|---|
| Analyze mandibular movements in intensive care patients | Other | To evaluate the performance of non-invasive mandibular movement analysis for measuring inspiratory effort compared to the reference technique (SEP variations) in ventilated ICU patients with spontaneous ventilation, during weaning from mechanical ventilation (phase 1) and within 48 hours post-extubation (phase 2).
The Sunrise sensor (Namur, Belgium), which records mandibular movements, will be inserted, as well as an esophageal pressure measurement catheter after removal of the usual feeding tube. Receives: Other: 2 recording phases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the correlation between the amplitude of mandibular movement signals and the variation in esophageal pressure (ΔPES) during changes in ventilatory conditions.
The comparison will focus on the values of ΔPES and mandibular movements averaged over a period of 5 respiratory cycles, and collected after a stabilization phase of the respiratory pattern of at least 5 minutes in each of the analysis conditions.
Measured: Period of weaning from mechanical ventilation followed by 7 days post extubation or discharge from intensive care (in a maximum of 10 days in total, i.e. 3 days of weaning and 7 days of post extubation follow-up).
Secondary outcomes (6)
Non-invasive assessment of ventilatory control based on clinical criteria and the ventilator
Measure of correlation between the following parameters:
- In patients on Spontaneous Breathing with Pressure Support (SB-PS) :
- value of recording of occlusion pressure (P0.1) in centimeter of H2O
- value of respiratory rate (RR) in cycle/minute
- value of inspiratory flow rate in Liter / minute
- value of peak pressure (Ppic) in centimeter of H2O
- value of expiratory tidal volume (Vte) in Liter
- value of inspiratory time (Ti) in seconds
- value of Vte/Ti ratio in Liter / seconds.
- In patients on non-invasive ventilation (NIV) and high-flow nasal oxygen (HFNO):
- value of respiratory rate in cycle/minute and, if available (NIV) :
- value of inspiratory flow rate in Liter / minute
- and value of expiratory tidal volume (Vte) in Liter and the value of PES or MM (measured separately) during respiratory cycles.
Measured: 30 minutes
Assessment of comfort and the sensation of dyspnea
Rating of dyspnea sensation using a visual analog scale from the better = 0 to the worse = 10, in units of the scale.
In patients on invasive mechanical ventilation, assessment using the ATICE scale (Adaptation To Intensive Care Environment) from the better = 20 to the worse = 0, in units of the scale.
Measured: 30 minutes
Diaphragmatic function assessment
Ultrasound measurement at the level of the right hemi-diaphragm of the fraction of thickening and diaphragmatic excursion.
Measured: 30 minutes
Evaluation of the concordance between the amplitude of mandibular movements and changes in ventilatory mechanics modeled by a multi-camera recording during the weaning trial.
Failure of the weaning trial as defined by the 2007 consensus conference:
Failure if at least one of the following criteria is met:
- SaO2 < 90% with FiO2 ≥ 50%;
- Respiratory distress (RR ≥ 40/min, agitation, cyanosis);
- Systolic blood pressure ≥ 180 mmHg;
- New cardiac arrhythmia;
- Respiratory acidosis (pH < 7.32 with PaCO2 ≥ 50 mmHg)
Measured: 30 minutes
Evaluation of the association between the amplitude of mandibular movements and failure of the weaning trial
Collection of reintubations occurring within 7 days of orotracheal extubation. The decision to reintubate will be left to the discretion of the physician in charge of the patient.
Measured: 7 days
Evaluation of the association between the amplitude of mandibular movements and extubation failure within 7 days.
Correlation between the measured tidal volume, the extrapolated tidal volume during thorax modeling, the amplitude of mandibular movements and the measured variation in esophageal pressure.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Failure (ARF)Studies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-center (Intensive Care Unit, Grenoble Alpes University Hospital), physiological, feasibility study evaluating the clinical and prognostic value of non-invasive mandibular movement analysis as a marker of inspiratory effort in spontaneously breathing critically ill patients.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Sunrise, National Institute in Computer science and automatic INRIA
- Responsible party
- Sponsor
- Investigators
- Florian SIGAUD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441590
- Sponsor's protocol ID
- 38RC25.0230 - MM-ICU
- Acronym
- MM-ICU
- Status last verified
- Feb 2026
- First submitted
- 16 Jan 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical and Prognostic Value of Non-invasive Analysis of Mandibular Movements (MM) as a Marker of Inspiratory Effort in the Spontaneously Breathing Intensive Care Patient
- ClinicalTrials.gov ID
- NCT07441590
- Acronym / sponsor ID
- MM-ICU / 38RC25.0230 - MM-ICU
- Conditions
- Acute Respiratory Failure (ARF), Intensive Care Unit (ICU) Patients, Invasive Mechanical Ventilation
- Keywords
- intensive care unit, acute respiratory failure, invasive mechanical ventilation, weaning from mechanical ventilation, ventilatory control, Breathing efforts
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Sunrise, National Institute in Computer science and automatic INRIA
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 2 Mar 2026 (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.
Evaluate the performance for measuring inspiratory effort of non-invasive mandibular movement analysis compared to the reference technique oesophageal pressure (PES) variation, in ventilated and spontaneously breathing Intensive Care Unity (ICU) patients, during weaning from mechanical ventilation and within 48 hours after extubation.
The investigators hypothesis is that the assessment of respiratory effort by MM analysis could represent a non-invasive and reliable alternative to the measurement of PES in critically ill patients.
Detailed description
Acute respiratory failure is the leading cause of ICU admission and is associated with high mortality. In patients with spontaneous breathing, inspiratory effort reflects ventilatory drive, which is frequently altered in critical illness due to the underlying pathology or its management.
Excessive inspiratory effort is associated with failure of non-invasive oxygenation strategies, difficult ventilator weaning, and increased mortality. Clinicians must therefore balance the benefits of maintaining spontaneous ventilation with the principles of protective ventilation to prevent lung injury induced either by the ventilator or by the patient.
The reference method for assessing inspiratory effort is esophageal pressure measurement (ΔPES), an invasive technique that limits routine clinical use. Recent studies suggest that non-invasive monitoring of mandibular movements provides a reliable assessment of respiratory effort.
The investigators hypothesize that analysis of mandibular movements could represent a reliable and non-invasive alternative to esophageal pressure measurement for evaluating respiratory effort in critically ill patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-center (Intensive Care Unit, Grenoble Alpes University Hospital), physiological, feasibility study evaluating the clinical and prognostic value of non-invasive mandibular movement analysis as a marker of inspiratory effort in spontaneously breathing critically ill patients.
| Arm | Type | Receives |
|---|---|---|
| Analyze mandibular movements in intensive care patients | Other | Other: 2 recording phasesTo evaluate the performance of non-invasive mandibular movement analysis for measuring inspiratory effort compared to the reference technique (SEP variations) in ventilated ICU patients with spontaneous ventilation, during weaning from mechanical ventilation (phase 1) and within 48 hours post-extubation (phase 2). The Sunrise sensor (Namur, Belgium), which records mandibular movements, will be inserted, as well as an esophageal pressure measurement catheter after removal of the usual feeding tube. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Adult patients (≥ 18 years)
- Admitted to the Intensive Care Unit for acute respiratory failure
- On invasive mechanical ventilation for more than 24 hours with:
- At high risk of weaning failure defined by at least one of the following criteria (5):
- Written informed consent obtained from the patient, or in case of incapacity, from the next of kin/trusted person
Key exclusion criteria (3 listed)
- Absolute contraindication to NIV (patient refusal, undrained pneumothorax, intractable vomiting, upper airway obstruction, upper gastrointestinal bleeding, severe craniofacial trauma)
- Absolute contraindication to nasogastric tube placement (upper gastrointestinal bleeding, epistaxis, skull base trauma)
- Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant woman, parturient woman, breastfeeding mother, person deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8, persons admitted to a health or social establishment for purposes other than research, minors, person subject to a legal protection measure or unable to express their consent).
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 |
|---|---|---|
| 2 recording phasesAn initial phase of recordings will be performed without sedation, during invasive mechanical ventilation (spontaneous ventilation with inspiratory support): recording of MM and PES will begin 30 minutes before the start of the weaning trial and will continue for 30 minutes during the trial. These measurements will be taken each day the clinician schedules a weaning trial until extubation. The weaning trial will be conducted according to the department's protocol and under medical supervision. The second phase will take place during the 48 hours following extubation, with the use of non-invasive ventilation alternating with high-flow humidified oxygen therapy to prevent extubation failure. The esophageal tube will remain in place during this period. The esophageal tube will remain in place. Recording of MM and SEEP will begin 30 minutes before the end of a non-invasive ventilation session and continue for 30 minutes with humidified high-flow oxygen therapy. | Other | Analyze mandibular movements in intensive care patients |
Primary outcome
Analysis of the correlation between the amplitude of mandibular movement signals and the variation in esophageal pressure (ΔPES) during changes in ventilatory conditions.
Time frame: Period of weaning from mechanical ventilation followed by 7 days post extubation or discharge from intensive care (in a maximum of 10 days in total, i.e. 3 days of weaning and 7 days of post extubation follow-up).
The comparison will focus on the values of ΔPES and mandibular movements averaged over a period of 5 respiratory cycles, and collected after a stabilization phase of the respiratory pattern of at least 5 minutes in each of the analysis conditions.
6 secondary outcomes
Non-invasive assessment of ventilatory control based on clinical criteria and the ventilator
Time frame: 30 minutes
Assessment of comfort and the sensation of dyspnea
Time frame: 30 minutes
Diaphragmatic function assessment
Time frame: 30 minutes
Evaluation of the concordance between the amplitude of mandibular movements and changes in ventilatory mechanics modeled by a multi-camera recording during the weaning trial.
Time frame: 30 minutes
Evaluation of the association between the amplitude of mandibular movements and failure of the weaning trial
Time frame: 7 days
Evaluation of the association between the amplitude of mandibular movements and extubation failure within 7 days.
Time frame: 7 days
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 2 Mar 2026.
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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.
Florian SIGAUD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 recording phases in people with Acute Respiratory Failure (ARF) and Intensive Care Unit (ICU) Patients, run by University Hospital, Grenoble 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 15 inclusion and 3 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 2 Mar 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?
Contact Florian SIGAUD (0476768076, fsigaud@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the correlation between the amplitude of mandibular movement signals and the variation in esophageal pressure (ΔPES) during changes in ventilatory conditions. (time frame: Period of weaning from mechanical ventilation followed by 7 days post extubation or discharge from intensive care (in a maximum of 10 days in total, i.e. 3 days of weaning and 7 days of post extubation follow-up).). 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 Mar 2026.