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

N/ANot Yet RecruitingNCT07441590

University Hospital, Grenoble50 enrolled

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.

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Interventions

2 recording phasesOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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.

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 Outcomes

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

Measure of correlation between the following parameters: 1. In patients on Spontaneous Breathing with Pressure Support (SB-PS) : * value of recording of occlusion pressure (P0.1) in centimeter of H2O * value of respiratory rate (RR) in cycle/minute * value of inspiratory flow rate in Liter / minute * value of peak pressure (Ppic) in centimeter of H2O * value of expiratory tidal volume (Vte) in Liter * value of inspiratory time (Ti) in seconds * value of Vte/Ti ratio in Liter / seconds. 2. 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 / minute * and value of expiratory tidal volume (Vte) in Liter and the value of PES or MM (measured separately) during respiratory cycles.

Time frame: 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.

Time frame: 30 minutes

Diaphragmatic function assessment

Ultrasound measurement at the level of the right hemi-diaphragm of the fraction of thickening and diaphragmatic excursion.

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.

Failure of the weaning trial as defined by the 2007 consensus conference: Failure if at least one of the following criteria is met: 1. SaO2 \< 90% with FiO2 ≥ 50%; 2. Respiratory distress (RR ≥ 40/min, agitation, cyanosis); 3. Systolic blood pressure ≥ 180 mmHg; 4. New cardiac arrhythmia; 5. Respiratory acidosis (pH \< 7.32 with PaCO2 ≥ 50 mmHg)

Time frame: 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.

Time frame: 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.

Time frame: 7 days

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

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts