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.
Adult patients (≥ 18 years)
Admitted to the Intensive Care Unit for acute respiratory failure
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);
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).
Single group
2 recording phases
Other interventionAn 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.
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.
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.
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.
Diaphragmatic function assessment
Ultrasound measurement at the level of the right hemi-diaphragm of the fraction of thickening and diaphragmatic excursion.
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)
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University Hospital, Grenoble
Lead sponsor
Sunrise
Collaborator
National Institute in Computer science and automatic INRIA
Collaborator
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