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ARDS is a pathology with mortality rates reaching 40%. Invasive ventilation, the cornerstone of ARDS management, leads to "ventilation-induced lung injury" (VILI). An approach based on pressure-controlled ventilation with unassisted spontaneous respirations (PC-SV or APRV) can limit the occurrence of VILI. Time-controlled adaptive ventilation (TCAV) is based on high mean inspiratory airway pressure, while limiting expiratory time at low pressure. TCAV has shown positive effects in experimental and observational studies. However, its efficacy and safety in patients with moderate-to-severe ARDS remains to be evaluated.
Evaluation of the efficacy of early application of TCAV compared to standard ventilation on the severity of alveolar damage leading to injury-related pulmonary edema in patients with moderate to severe ARDS After obtaining patient's consent, eligible patients will be included in this open-label, randomized controlled pilot study with stratification by minimization based on initial severity. The experimental group will be the TCAV group, where ventilator settings will be standardized. The ventilator in the standard care group will be set to volumetric mode with positive end-expiratory pressure according to the EXPRESS protocol.
The measurement of extravascular lung water will be compared on day 2 between the TCAV settings group and the standard care settings group using the PICCO system.
The TCAV setting is simple and inexpensive. In ARDS patients, the increase in injury-related pulmonary edema is a relevant marker of mortality, and its reduction could improve patients' outcomes. Our study aims to evaluate the efficacy and safety of these settings to justify a future large-scale, multicenter randomized trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time-controlled Adaptative Ventilation | Experimental | Invasive ventilation with the ventilator set on the Airway Pressure Release Ventilation mode. |
|
| Volume Control | Active Comparator | Invasive ventilation with the ventilator set on the Volume control mode. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Invasive ventilation with the Time-controlled Adaptative Ventilation settings applied to the Airway Pressure Release Ventilation mode | Other | Invasive ventilation with the ventilator set on the Airway Pressure Release Ventilation mode as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| Extravascular Lung Water (EVLW) | Measured with transpulmonary thermodilution (TPTD) and expressed in ml per kilogram of body weight | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Occurrence of death | 60 days |
| Ventilator-free days | Number of days without invasive or non-invasive ventilation | day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthieu KOSZUTSKI, MD | Contact | +33 3 83 15 30 17 | m.koszutski@chru-nancy.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Nancy | Nancy | 54000 | France |
|
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| Volume Control | Other | Invasive ventilation with the ventilator set on the Volume control mode as follows:
|
|
| Major Adverse Kidney Events (MAKE) | Need of dialysis, decrease ≥ 25% of glomerular filtration rate and all cause-death | Day 7, Day 30 |
| Adverse Events | Defined as:
| Day 30 |
| Pressure difference | in cmH20 | day 1, day 2, day 3, day 4 |
| Extravascular Lung Water Indexed to the predicted body weight (EVLWIp) | Measured with transpulmonary thermodilution (TPTD) and expressed in ml per kilogram of predicted body weight | 48 hours |
| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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