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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

Sponsor: University Hospital, Grenoble

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-02

Completion Date

2027-04

Last Updated

2026-03-02

Healthy Volunteers

Conditions

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

Interventions

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.

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).

Locations (1)

University Hospital Grenoble

Grenoble, Auvergne-Rhône-Alpes, France