NCT07441590

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
OTHER	2 recording phases	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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-02-01
• Completion: 2027-04-01
• First posted: 2026-03-02
• Last updated: 2026-03-02

Locations

1 site across 1 country: France