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| Name | Class |
|---|---|
| Istituto Di Ricerche Farmacologiche Mario Negri | OTHER |
| University of Bari Aldo Moro | OTHER |
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The present study set up to answer two questions: (a) "how low tidal volume must be to provide protective ventilatory settings able to minimize the risk of death due to Ventilator-Induced Lung Injury (VILI)?"; (b) "if protection from VILI is better achieved by targeting the driving pressure instead of the tidal volume, what is the optimal target for the driving pressure?". Solving these questions is pivotal for clinicians to personalized and precise mechanical ventilation practices to reduce the risk of VILI and avoid unnecessary risks associated to protective ventilatory settings.
Two multicenter emulated target trials will be performed using data collected with the Electronic Health Record MargheritaTre, to investigate the effect of low tidal volumes (6.0 to 8.0 ml/kg PBW vs 8.0 to 10.0 ml/kg PBW) and low driving pressures (7.0-12.0 cmH2O vs 12.0-18.0 cmH2O), respectively. Data will be used to obtain the dose-response curve of lower VT and lower ∆P in mechanically ventilated patients with acute severe hypoxemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VT1 - low tidal volume | Patients mechanically ventilated with tidal volume between 6.0 and 8.0 ml/kg PBW, until weaning conditions are satisfied. When weaning criteria are met, extubation may be attempted, it may either fail or not, or any other mechanical ventilation regime may be chosen, according to clinical practice. |
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| VT2 - high tidal volume | Patients mechanically ventilated with tidal volume between 8.0 and 10.0 ml/kg PBW, until weaning conditions are satisfied. When weaning criteria are met, extubation may be attempted, it may either fail or not, or any other mechanical ventilation regime may be chosen, according to clinical practice. |
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| ∆P1 - low driving pressure | Patients mechanically ventilated with driving pressure between 7.0 and 12.0 cmH2O, until weaning conditions are satisfied. When weaning criteria are met, extubation may be attempted, it may either fail or not, or any other mechanical ventilation regime may be chosen, according to clinical practice. |
| |
| ∆P2 - high driving pressure | Patients mechanically ventilated with driving pressure between 12.0 and 18.0 cmH2O, until weaning conditions are satisfied. When weaning criteria are met, extubation may be attempted, it may either fail or not, or any other mechanical ventilation regime may be chosen, according to clinical practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low tidal volume | Device | Patients ventilated with assist/control modes of mechanical ventilation with tidal volume between 6.0 ml/kg PBW and 8.0 ml/kg PBW with PPLAT ≤ 30 cmH2O, until weaning criteria are met: P/F ratio > 250 mmHg; PEEP ≤ 8 cmH2O and lower than the previous day; FiO2 < 0.5 and lower than the previous day; systolic arterial pressure ≥ 85 mmHg. |
| Measure | Description | Time Frame |
|---|---|---|
| ICU all-cause mortality | All patients will be classified as either alive if "alive at ICU discharge" or dead if "dead at ICU discharge" | 14 days from assignment to intervention arm |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator-free days | Number of ventilator-free days (VFDs) during the 14 days in ICU | 14 days from assignment to intervention arm |
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Inclusion Criteria:
all the following conditions present continuously for 24 hours commencing within 36 hours of ICU admission, while the patient is undergoing invasive mechanical ventilation in either flow or pressure- regulated assist/controlled modes:
Exclusion Criteria:
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All adult patients admitted to an ICU adopting MargheritaTre as electronic health record satisfying inclusion and exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mario Negri Institute for Pharmacological Research IRCCS | Ranica | BG | 24020 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 23, 2024 | Dec 23, 2024 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D055371 | Acute Lung Injury |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D055370 | Lung Injury |
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| high tidal volume | Device | Patients ventilated with assist/control modes of mechanical ventilation with tidal volume between 8.0 ml/Kg PBW and 10.0 ml/kg PBW with PPLAT ≤ 30 cmH2O, until weaning criteria are met: P/F ratio > 250 mmHg; PEEP ≤ 8 cmH2O and lower than the previous day; FiO2 < 0.5 and lower than the previous day; systolic arterial pressure ≥ 85 mmHg. |
|
| low driving pressure | Device | Patients ventilated with assist/control modes of mechanical ventilation with driving pressure between 7.0 cmH2O and 12.0 cmH2O with VT ≤ 10 ml/kg PBW, until weaning criteria are met: P/F ratio > 250 mmHg; PEEP ≤ 8 cmH2O and lower than the previous day; FiO2 < 0.5 and lower than the previous day; systolic arterial pressure ≥ 85 mmHg. |
|
| high driving pressure | Device | Patients ventilated with assist/control modes of mechanical ventilation with driving pressure between 12.0 cmH2O and 18.0 cmH2O with VT ≤ 10 ml/kg PBW, until weaning criteria are met: P/F ratio > 250 mmHg; PEEP ≤ 8 cmH2O and lower than the previous day; FiO2 < 0.5 and lower than the previous day; systolic arterial pressure ≥ 85 mmHg. |
|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |