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Although mechanical ventilation remains the cornerstone of ARDS treatment, several experimental and clinical studies have undoubtedly demonstrated that it can contribute to high mortality through the developing of ventilator induced lung injury even in patients with plateau pressure <30 cmH2O. Since now there are no studies exploring the application of low flow extracorporeal CO2 removal and ultraprotective ventilation to reduce mechanical power, a composite index of VILI, independently from the value of plateau pressure or the severity of hypercapnia.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal CO2 Removal | Other | Extracorporeal carbon dioxide removal (ECCO2R), a low flow extracorporeal CO2 removal, may be used in association with ultraprotective mechanical ventilation (tidal volume < 6 ml/kg and Pplat <20-25 cmH2O). |
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical Power reduction. | Achievement of Mechanical Power reduction under 18 J/min while maintaining pH and PaCO2 to ± 20% of baseline values obtained at tidal volume of 6 mL/kg. Mechanical Power (MP) (J/min) = 0.098 * respiratory rate * tidal volume (inspiratory peak airway pressure - 1/2 * (airway pressure at end inspiratory pause - airway pressure at PEEP)) | Changes from baseline to day 5. |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory mechanics. | 1. Respiratory system elastance (Ers) (cmH2O/L) = (airway pressure at end inspiratory pause - airway pressure at PEEP) / tidal volume | Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days |
| Respiratory mechanics. |
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Inclusion Criteria:
ARDS patients undergoing mechanical ventilation with:
Exclusion Criteria:
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Adult respiratory distress syndrome (ARDS) patients, affected by a life-threatening condition characterized by nonhydrostatic pulmonary edema that can be caused by pulmonary (eg, pneumonia, aspiration) or nonpulmonary (eg, sepsis, pancreatitis, trauma) insults and accounts for 10% of intensive care unit (ICU) admissions. Mortality remains high ranging from 35% to 46% and it has been estimated that at least 150,000 individuals die each year of adult respiratory distress syndrome.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Davide Chiumello, Professor | Contact | +390281844020 | chiumello@libero.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASST-Santi Paolo e Carlo, San Paolo Hospital | Recruiting | Milan | 20142 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26903337 | Background | Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. | |
| 16352797 |
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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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2. Lung elastance (El) (cmH2O/L) = (transpulmonary pressure at end inspiratory pause - transpulmonary pressure at PEEP / tidal volume |
| Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days |
| Respiratory mechanics. | 3. Chest wall elastance (Ecw) (cmH2O/L) = (esophageal pressure at end inspiratory pause - esophageal pressure at PEEP) / tidal volume | Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days |
| Respiratory mechanics. | 4. End inspiratory transpulmonary pressure (cmH2O)= airway pressure at end inspiratory pause - (esophageal pressure at end inspiratory pause - expiration at atmospheric pressure by a release manouvre). | Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days |
| Gas exchange. | Assessment of changes in PaCO2 mmHg. | Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days |
| Gas exchange. | Assessment of changes in PaO2 mmHg. | Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days |
| Gas exchange. | Assessment of changes in PaO2/FiO2. | Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days |
| Safety assessment and adverse device related events: frequency of serious adverse events | Safety assessment reporting frequency of serious adverse events in terms of device related mechanical events (Pump malfunction, membrane lung clotting, system leaks, tubing rupture, air in the circuit) and device related clinical events (heamolysis, significant bleeding, thromboembolic complications, neurologic complications, metabolic complications). | Every day, until the fifth day or until the weaning from ECCO2R if lower than five days |
| Background |
| Fan E, Needham DM, Stewart TE. Ventilatory management of acute lung injury and acute respiratory distress syndrome. JAMA. 2005 Dec 14;294(22):2889-96. doi: 10.1001/jama.294.22.2889. |
| 10793162 | Background | Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801. |
| 28899408 | Background | Chiumello D, Brochard L, Marini JJ, Slutsky AS, Mancebo J, Ranieri VM, Thompson BT, Papazian L, Schultz MJ, Amato M, Gattinoni L, Mercat A, Pesenti A, Talmor D, Vincent JL. Respiratory support in patients with acute respiratory distress syndrome: an expert opinion. Crit Care. 2017 Sep 12;21(1):240. doi: 10.1186/s13054-017-1820-0. |
| 27620287 | Background | Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12. |
| 26872367 | Background | Cressoni M, Gotti M, Chiurazzi C, Massari D, Algieri I, Amini M, Cammaroto A, Brioni M, Montaruli C, Nikolla K, Guanziroli M, Dondossola D, Gatti S, Valerio V, Vergani GL, Pugni P, Cadringher P, Gagliano N, Gattinoni L. Mechanical Power and Development of Ventilator-induced Lung Injury. Anesthesiology. 2016 May;124(5):1100-8. doi: 10.1097/ALN.0000000000001056. |
| 625133 | Background | Kolobow T, Gattinoni L, Tomlinson T, Pierce JE. An alternative to breathing. J Thorac Cardiovasc Surg. 1978 Feb;75(2):261-6. |
| 17187683 | Background | Peek GJ, Clemens F, Elbourne D, Firmin R, Hardy P, Hibbert C, Killer H, Mugford M, Thalanany M, Tiruvoipati R, Truesdale A, Wilson A. CESAR: conventional ventilatory support vs extracorporeal membrane oxygenation for severe adult respiratory failure. BMC Health Serv Res. 2006 Dec 23;6:163. doi: 10.1186/1472-6963-6-163. |