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

Overview

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.

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.

Primary outcome measures

• Analysis of the correlation between the amplitude of mandibular movement signals and the variation in esophageal pressure (ΔPES) during changes in ventilatory conditions. [Time frame: 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 (6)

• Non-invasive assessment of ventilatory control based on clinical criteria and the ventilator [Time frame: 30 minutes]
• Assessment of comfort and the sensation of dyspnea [Time frame: 30 minutes]
• Diaphragmatic function assessment [Time frame: 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. [Time frame: 30 minutes]
• Evaluation of the association between the amplitude of mandibular movements and failure of the weaning trial [Time frame: 7 days]
• Evaluation of the association between the amplitude of mandibular movements and extubation failure within 7 days. [Time frame: 7 days]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

France · 1 center

• University Hospital Grenoble — Grenoble

Identifiers

NCT: NCT07441590 · 38RC25.0230 - MM-ICU

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗