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 (MM-ICU)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Invasive Mechanical Ventilation; Intensive Care Unit (ICU) Patients; Acute Respiratory Failure (ARF)
• Intervention / Treatment: Other: 2 recording phases

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florian SIGAUD; Phone Number: 0476768076; Email: fsigaud@chu-grenoble.fr
• Study Contact Backup: Name: Roselyne COLLOMB-MURET; Phone Number: 0476767109; Email: rcollombmuret@chu-grenoble.fr

Study Locations

• France
  • Auvergne-Rhône-Alpes
    • Grenoble, Auvergne-Rhône-Alpes, France, 38043
      • University Hospital Grenoble
      • Contact: Florian SIGAUD; Phone Number: 0476768076; Email: fsigaud@chu-grenoble.fr
      • Contact: Roselyne COLLOMB-MURET; Phone Number: 0476767109; Email: rcollombmuret@chu-grenoble.fr
      • Sub-Investigator: Guillaume DUMAS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Analyze mandibular movements in intensive care patients; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 H2Ovalue of respiratory rate (RR) in cycle/minutevalue of inspiratory flow rate in Liter / minutevalue of peak pressure (Ppic) in centimeter of H2Ovalue of expiratory tidal volume (Vte) in Litervalue of inspiratory time (Ti) in secondsvalue 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 / minuteand value of expiratory tidal volume (Vte) in Liter and the value of PES or MM (measured separately) during respiratory cycles.	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.	30 minutes
Diaphragmatic function assessment	Ultrasound measurement at the level of the right hemi-diaphragm of the fraction of thickening and diaphragmatic excursion.	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)	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.	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.	7 days

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Sunrise; National Institute in Computer science and automatic INRIA
• Investigators: Principal Investigator: Florian SIGAUD, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: January 16, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: intensive care unit; acute respiratory failure; invasive mechanical ventilation; weaning from mechanical ventilation; ventilatory control; Breathing efforts
• Other Study ID Numbers: 38RC25.0230 - MM-ICU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No