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 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Grenoble

Phase

Not applicable

Started

2026-02

Last updated

2026-03-02

Condition(s) studied

Acute Respiratory Failure (ARF)Intensive Care Unit (ICU) PatientsInvasive Mechanical Ventilation

Investigational drug(s) / intervention(s)

2 recording phases

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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).

Primary outcome measure(s)

Analysis of the correlation between the amplitude of mandibular movement signals and the variation in esophageal pressure (ΔPES) during changes in ventilatory 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).
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.

Trial sites (1)

Facility	City	Region	Status
University Hospital Grenoble	Grenoble	Auvergne-Rhône-Alpes

More University Hospital, Grenoble trials in France

Osteosynthesis of Fibula Fractures With a Locked Thin Plate Starting soon

High Intensity Interval Training Versus Moderate Intensity Continuous Training in Frail Elderly Recruiting

Isolation of Human Recombinant Therapeutic Monoclonal Anti-Pseudomonas Antibodies Recruiting

Bradykinin-degradating Enzymes Activities in Angiotensin-Converting Enzyme Inhibitors-associated Angioedema Recruiting

Cardiovascular Risk and Chronic Obstructive Pulmonary Disease Recruiting

Other trials for the same condition

Study of Interactions Between Oncologists and Resuscitators to Optimize Decision Making for Admission of Patients With Metastatic Solid Cancer to the ICU (InterOncoRea) Active, not recruiting

Lung Recruitment During Chest Physiotherapy in Mechanically Ventilated Patients Recruiting

Music Therapy During NIV Implantation in Pediatric Intensive Care Units Recruiting

Evaluation of Rehabilitation Practices in the Intensive Care Unit Recruiting

Pets Enhancing Therapeutics in Intensive Care Units Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07441590 on ClinicalTrials.gov ↗ ← All trials in France