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Aim of mechanical ventilation is to improve gas exchange and to unload the respiratory muscles delivering a form of mechanical support to the ventilation. At the same time, it is essential that the support is individually-tailored to avoid the development of muscular atrophy, a process called "ventilatory-induced diaphragm dysfunction"
Aim of the present study is that the continuous ultrasonographic assesment of diaphragm function, as obtained by the device under investigation (DiaMon, Respinor AS, Oslo, Norway) is related to the degree of effort of inspiratory muscles, as measured by gold-standard indices such as esophageal and gastric pressure measurement.
A secondary aim is that the data assessed by the device are related to a standard ultrasonographic examination performed by expert operators.
In particular, we will enroll a population of critically ill patients undergoing mechanical ventilation in assisted mode, and we will perform a decremental pressure support trial, with the following aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical pressure support | Placebo Comparator | The level of inspiratory pressure support will be selected by the attending physician |
|
| Reduced pressure support | Active Comparator | The level of inspiratory pressure support will be reduced by 25% |
|
| Lowest pressure support | Active Comparator | The level of inspiratory pressure support will be reduced by 50% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assesment of diaphragm function | Diagnostic Test | Diaphragm function will be assessed by standard mechanical parameters as assessed by esophageal and gastric pressure measurement, as well as by an ultrasonographic examination performed by an expert operator and by the continuous ultrasonographic assessment provided by the device under investigation |
| Measure | Description | Time Frame |
|---|---|---|
| Diaprhagm excursion | Excursion (in mm) between expiration and inspiration | Study 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Esophageal pressure swing | Difference (in cmH2O) in esophageal pressure between expiration and inspiration | Study 1 day |
| Pressure-time product | Integral of the area under the esophageal pressure over time (in cmH2O*sec) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Davide Chiumello | Contact | +390281844476 | davide.chiumello@unimi.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Paolo - Polo Universitario, ASST Santi Paolo e Carlo | Recruiting | Milan | MI | 20142 | Italy |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Study 1 day |
| Pressure-time product | Integral of the area under the trasndiaphragmatic pressure over time (in cmH2O*sec) | Study 1 day |
| D020969 | Disease Attributes |