Evaluation of the Clinical and Prognostic Value of Non-invasive Analysis of Mandibular Movements … (NCT07441590) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
France50 participantsStarted 2026-02
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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;
* 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
Exclusion Criteria:
* Absolute contraindication to NIV (patient refusal, undrained pneumoth…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Analysis of the correlation between the amplitude of mandibular movement signals and the variation in esophageal pressure (ΔPES) during changes in ventilatory conditions.
Timeframe: 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).