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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A00551-42 | Other Identifier | IDRCB number (ANSM) |
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The care of acute respiratory distress syndrome (ARDS) has been significantly improved by learning from experimental and physiological research works and by a series of randomized controlled trials. The mortality of this syndrome remains however high. Numerous experimental and clinical works demonstrated that a ventilatory mode authorizing the patient to make, from the acute phase, spontaneous breathing cycles superimposed on assistance delivered by the ventilator (BIPAP-APRV mode) allowed to improve gas exchanges and hemodynamic tolerance of the ventilation while reducing the need for sedative drugs. This ventilatory mode could also reduce the risk of diaphragmatic dysfunction induced by ventilation. Consequently, our hypothesis is that this ventilatory mode could allow a reduction of mortality in ARDS patients.
The aim of this multicenter, prospective, randomized, controlled, open study is to compare the effects of two ventilatory strategies on the mortality of ARDS patients and placed under mechanical ventilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAC mode, Controlled ventilation | Active Comparator | From randomization, patients are put under controlled ventilation with specific settings |
|
| APRV mode, Spontaneous breathing | Experimental | During 1 to 3 hours after randomization, patients are put under controlled ventilation with specific settings for baseline data. After that, they are placed under APRV mode with specific settings |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APRV | Procedure | Pressure ventilation mode allowing early spontaneous breathing |
|
| Measure | Description | Time Frame |
|---|---|---|
| all cause hospital mortality | participants will be followed for the duration of hospital stay, until day 60 maximum. | hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| all causes mortality | Day 28 | |
| number of days alive without mechanical ventilation | day 28 | |
| number of days alive without organ failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Intensive Care Unit, University Hospital of Angers | Angers | 49933 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39287651 | Derived | Richard JM, Beloncle FM, Beduneau G, Mortaza S, Ehrmann S, Diehl JL, Prat G, Jaber S, Rahmani H, Reignier J, Boulain T, Yonis H, Richecoeur J, Thille AW, Declercq PL, Antok E, Carteaux G, Vielle B, Brochard L, Mercat A; REVA network. Pressure control plus spontaneous ventilation versus volume assist-control ventilation in acute respiratory distress syndrome. A randomised clinical trial. Intensive Care Med. 2024 Oct;50(10):1647-1656. doi: 10.1007/s00134-024-07612-3. Epub 2024 Sep 17. |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| arterial blood gas measurement each morning | Biological |
|
| day 28 |
| number of patients with refractory hypoxemia | day 7 |
| number of patients requiring adjuvant treatment of hypoxemia | day 7 |
| number of days alive without sedation | Day 28 |
| total amount of sedative drugs | between baseline and day 7 |
| amount of sedative drugs received daily living | between baseline and day 7 |
| number of days alive without vasoactive drugs | day 28 |
| total amount of vasoactive drugs | between baseline and day 7 |
| amount of vasoactive drugs received daily living | between baseline and day 7 |
| Number of patients with a pneumothorax | day 28 |
| Duration of mechanical ventilation | day 60 |
| Duration of stay in ICU | day 60 |
| Changes in serum levels of proinflammatory cytokines | Hour 1 and Hour 48 |