ECCO2R - Mechanical Power Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Mechanical Power reduction. [Changes from baseline to day 5.]
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))
Secondary Outcome Measures
- Respiratory mechanics. [Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days]
1. Respiratory system elastance (Ers) (cmH2O/L) = (airway pressure at end inspiratory pause - airway pressure at PEEP) / tidal volume
- Respiratory mechanics. [Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days]
2. Lung elastance (El) (cmH2O/L) = (transpulmonary pressure at end inspiratory pause - transpulmonary pressure at PEEP / tidal volume
- Respiratory mechanics. [Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days]
3. Chest wall elastance (Ecw) (cmH2O/L) = (esophageal pressure at end inspiratory pause - esophageal pressure at PEEP) / tidal volume
- Respiratory mechanics. [Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days]
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).
- Gas exchange. [Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days]
Assessment of changes in PaCO2 mmHg.
- Gas exchange. [Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days]
Assessment of changes in PaO2 mmHg.
- Gas exchange. [Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days]
Assessment of changes in PaO2/FiO2.
- Safety assessment and adverse device related events: frequency of serious adverse events [Every day, until the fifth day or until the weaning from ECCO2R if lower than five days]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
ARDS patients undergoing mechanical ventilation with:
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PaO2/FiO2 <150 with a level of positive end expiratory pressure (PEEP) of 10 cmH2O or higher with a FiO2 > 0.5
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Plateau pressure of 28 cmH2O or higher with tidal volume of 6 ml/Kg of ideal body weight
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Mechanical power of 18 J/min or higher.
Exclusion Criteria:
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<18 years of age
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Pregnancy
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Obesity with BMI> 30
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Platelets <30 G/l
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Decompensated heart failure or acute coronary syndrome
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Acute brain injury
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Contraindication for systemic anticoagulation (for example, gastrointestinal bleeding, recent cerebrovascular accident, or chronic bleeding disorder, recent major surgery)
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Patient moribund, decision to limit therapeutic interventions
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Catheter access to femoral vein or jugular vein impossible
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Pneumothorax.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ASST-Santi Paolo e Carlo, San Paolo Hospital | Milan | Italy | 20142 |
Sponsors and Collaborators
- University of Milan
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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. Erratum in: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.
- 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. Review.
- 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.
- 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. Review.
- 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.
- Kolobow T, Gattinoni L, Tomlinson T, Pierce JE. An alternative to breathing. J Thorac Cardiovasc Surg. 1978 Feb;75(2):261-6.
- 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.
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