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| Name | Class |
|---|---|
| Sunrise | INDUSTRY |
| National Institute in Computer science and automatic INRIA | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Analyze mandibular movements in intensive care patients | Other | To evaluate the performance of non-invasive mandibular movement analysis for measuring inspiratory effort compared to the reference technique (SEP variations) in ventilated ICU patients with spontaneous ventilation, during weaning from mechanical ventilation (phase 1) and within 48 hours post-extubation (phase 2). The Sunrise sensor (Namur, Belgium), which records mandibular movements, will be inserted, as well as an esophageal pressure measurement catheter after removal of the usual feeding tube. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2 recording phases | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Non-invasive assessment of ventilatory control based on clinical criteria and the ventilator | Measure of correlation between the following parameters:
and the value of PES or MM (measured separately) during respiratory cycles. |
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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:
At high risk of weaning failure defined by at least one of the following criteria (5):
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florian SIGAUD | Contact | 0476768076 | fsigaud@chu-grenoble.fr | |
| Roselyne COLLOMB-MURET | Contact | 0476767109 | rcollombmuret@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Florian SIGAUD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Grenoble | Grenoble | Auvergne-Rhône-Alpes | 38043 | France |
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This is a prospective, single-center (Intensive Care Unit, Grenoble Alpes University Hospital), physiological, feasibility study evaluating the clinical and prognostic value of non-invasive mandibular movement analysis as a marker of inspiratory effort in spontaneously breathing critically ill patients.
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| 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. | 30 minutes |
| Diaphragmatic function assessment | Ultrasound measurement at the level of the right hemi-diaphragm of the fraction of thickening and diaphragmatic excursion. | 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:
| 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. | 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. | 7 days |