Intensive Care Unit Clinical Trial
— InLargeOfficial title:
Effects of Large Tidal Volumes Despite Minimal Inspiratory Support in Spontaneously Ventilated Intubated Resuscitation Patients. Pathophysiological Exploratory Study.
Some ICU ventilated patients might present with large tidal volume despite very low or inexistant presser support. Patient-Self Inflicted Lung Injury (P-SILI) might appear related with large alveolar stretch an distension. Two clinical presentations are observed: patients with or without respiratory distress signs such as supra-clavicular depression and thoracic-abdominal asynchronies. The aim of this study is to compare the pulmonary physio(-patho)logical parameters of these two types of patients (eupneic or with respiratory distress signs), and presenting important TV in spite of a minimal adjustment of the ventilatory support, except for Acute Respiratory Distress Syndrome (ARDS).
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 25, 2023 |
Est. primary completion date | June 25, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients over 18 years old - Patients admitted to the adult intensive care unit at Estaing Hospital, Clermont-Ferrand - Patients under invasive mechanical ventilation (intubation or tracheostomy) - Patients with a tidal volume greater than 10 mL.kg-1 of predicted body weight despite a minimal pressure support (< 5 cmH2O) - Patients with sedation compatible with spontaneous ventilation with inspiratory support and positive end-expiratory pressure - Patient calm (RASS between -2 and 0) - Consent to participate in the study from the patient or authorization to carry out the research collected from the designated trusted person (failing that, a family member or a close relative who has a close and stable relationship with the patient) in accordance with the procedures described in Title II of the First Book of the Public Health Code. If no relative is present, the patient may be included on the advice of the investigator (article L. 1111-6). A consent form for the continuation of the study and the use of the data will then be signed by the patient if and when he/she is conscious and lucid again, or if the patient is unable to express his/her consent, an authorization to continue the research will be obtained from the designated trusted person - Patient benefiting from a Social Security system Exclusion Criteria: - Refusal to participate in the proposed study - Protected adults - Contraindication to the placement of a nasogastric tube: - Severe uncorrected blood flow disorder - Known naso-sinusal lesion - Recently ligated esophageal varices (< 48h) - Contraindication to the use of the tomographic electroimpedancemetry technique - Thoracic lesions - Thoracic dressings - Pace-maker/implantable defibrillator - Known injury to central respiratory centers, including neurocompromised patients - Patients with Acute Respiratory Distress Syndrome (according to Berlin criteria) |
Country | Name | City | State |
---|---|---|---|
France | CHU | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Transpulmonary driving pressure | Comparison of transpulmonary motor pressure levels during spontaneous invasive mechanical ventilation of patients with large tidal volumes (>10 mL.kg-1 theoretical ideal weight) despite minimal pressure support (inspiratory support <5 cmH20). Transpulmonary motor pressure is defined as follows:
?Ptp = (Pplateau - Inspiratory Poeso) - (PEEP - Expiratory Poeso) |
During 1 hour starting from inclusion | |
Secondary | Transpulmonary pressure (alveolar stress) | Maximum transpulmonary pressure (alveolar stress) defined as follows:
Ptp = Pplateau - Inspiratory Poeso |
At inclusion and after 1 hour | |
Secondary | Pressure of respiratory occlusion (P0,1) | Pressure of respiratory occlusion (P01) representative of respiratory drive, automatically delivered by the ventilator | At inclusion and after 1 hour | |
Secondary | Driving pressure | Driving pressure | At inclusion and after 1 hour | |
Secondary | Work of breathing | Work of breathing as defined as follows:
WOB = ?P x ?V during inspiration |
At inclusion and after 1 hour | |
Secondary | Alveolar strain | Alveolar strain defined as follows:
Strain = TV / FRC |
At inclusion and after 1 hour | |
Secondary | Energy transmitted to the patient's lungs by the ventilator | Energy transmitted to the patient's lungs by the ventilator as defined by Gattinoni et al. (Intensive Care Medicine 2016) | At inclusion and after 1 hour |
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