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

NCT07441590 | Not Yet Recruiting

• 1 other identifier: 38RC25.0230 - MM-ICU
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Non-invasive assessment of ventilatory control based on clinical criteria and the ventilator

  30 minutes

• Assessment of comfort and the sensation of dyspnea

  30 minutes

• Diaphragmatic function assessment

  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.

  30 minutes

• Evaluation of the association between the amplitude of mandibular movements and failure of the weaning trial

  7 days

Study Arms (1)

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.

Other: 2 recording phases

Interventions

2 recording phases OTHER

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.

Analyze mandibular movements in intensive care patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Sunrise: collaborator
• National Institute in Computer science and automatic INRIA: collaborator

Study Sites (1)

University Hospital Grenoble

Grenoble, Auvergne-Rhône-Alpes, 38043, France

Location

Study Officials

• Florian SIGAUD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florian SIGAUD

CONTACT

0476768076; fsigaud@chu-grenoble.fr

Roselyne COLLOMB-MURET

CONTACT

0476767109; rcollombmuret@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: March 2, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

FR (1)