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Patients admitted to the intensive care unit (ICU) and mechanically ventilated for reasons other than acute respiratory failure, such as coma, trauma, or sepsis, are at risk of developing acute respiratory distress syndrome (ARDS), which increases the duration of mechanical ventilation, mortality, and functional dependence at discharge.
Patients admitted to the intensive care unit (ICU) and mechanically ventilated for reasons other than acute respiratory failure, such as coma, trauma, or sepsis, are at risk of developing acute respiratory distress syndrome (ARDS), which increases the duration of mechanical ventilation, mortality, and functional dependence at discharge. Low tidal volume mechanical ventilation is recommended for these patients to prevent ARDS, but few other modifiable risk factors are known. Advanced respiratory monitoring, which includes continuous recording of airway and esophageal pressure, inspiratory and expiratory flow, and the distribution of ventilation within the lungs, has been used in patients with ARDS to personalize ventilation parameters, prevent ventilator-induced lung injury (VILI), and improve outcomes. It is unknown whether the use of these same monitoring techniques in patients without respiratory failure at the time of ICU admission can prevent the development of ARDS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients without acute respiratory failure undergoing mechanical ventilation. | Adult patients without acute respiratory failure undergoing mechanical ventilation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advanced Non-Invasive Respiratory Monitoring | Diagnostic Test | Continuous measurement and recording of airway pressure, esophageal pressure, inspiratory and expiratory flow, and electrical impedance tomography (EIT) data during the first 24 hours of mechanical ventilation. A nasogastric tube equipped with an esophageal balloon is placed alongside an EIT electrode belt. Monitoring is performed continuously off-line without altering standard clinical management. Residual respiratory function is also evaluated via spirometry and EIT prior to Intensive Care Unit (ICU) discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Acute Respiratory Distress Syndrome (ARDS) | Association between ARDS development and advanced respiratory monitoring parameters derived from: Airway pressure/flow analysis: tidal volume/kg of ideal body weight, respiratory rate, plateau pressure, driving pressure, respiratory system compliance, and stress index. Esophageal pressure analysis: lung compliance, transpulmonary plateau pressure, transpulmonary driving pressure, and chest wall compliance. Electrical impedance tomography (EIT): regional compliance and tidal volume distribution homogeneity. | Within the first 7 days of Intensive Care Unit (ICU) admission. |
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Study Population Eligibility Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No
Inclusion Criteria:
Adult patients +18 years. Undergoing invasive mechanical ventilation for reasons other than acute respiratory failure (such as coma, trauma, or sepsis).
Initiation of monitoring within 24 hours of oro-tracheal intubation.
Exclusion Criteria:
Evidence of pneumothorax, pneumomediastinum, or subcutaneous emphysema. Pregnancy. Absolute contraindications to nasogastric tube placement. Absolute contraindications to electrical impedance tomography (EIT) monitoring.
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The study population consists of adult patients admitted to the Intensive Care Unit (ICU) who require invasive mechanical ventilation for reasons entirely distinct from acute respiratory failure, such as coma, trauma, or sepsis. Eligible individuals must be enrolled and have monitoring initiated within the first 24 hours of oro-tracheal intubation. The cohort excludes patients with specific barotrauma complications, pregnant individuals, and those with absolute clinical contraindications to the required monitoring procedures.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanitas Research Hospital | Recruiting | Milan | Lombardy | 20089 | Italy |
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