Mechanical Ventilation Complication Clinical Trial
Official title:
Open Lung Strategy, Gas Distribution and Right Heart Function in ARDS Patients: an Open Lung is a Better Heart
NCT number | NCT03202641 |
Other study ID # | OLA-HEART |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 19, 2019 |
Est. completion date | August 2024 |
The goal of this interventional crossover study, in intubated and mechanically ventilated Acute Respiratory Distress Syndrome (ARDS) patients, is to compare two positive end-expiratory pressure (PEEP) titration techniques regarding: respiratory mechanics, gas exchange, changes in aeration, ventilation/perfusion matching its impact on cardiac function, especially the right heart (RH). The PEEP titration techniques are: PEEP selection based on low PEEP/high FiO2 table ("PEEPARDSnet") and lung recruitment maneuver (LRM) plus PEEPdec titration based on the best compliance of the respiratory system("PEEPLRM").
Status | Recruiting |
Enrollment | 50 |
Est. completion date | August 2024 |
Est. primary completion date | April 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - ARDS diagnosis within 72h after intubation - Severe to moderate ARDS (PaO2 / FiO2 < 200 mmHg) with PEEP>5 cmH2O - Presence of an arterial line - Between 18 and 85 years old Exclusion Criteria: - Persistent systolic blood pressure < 90 mmHg and/or >180 mmHg despite the use of vasopressor or vasodilators - Increment in vasopressors over the past two hour just before enrollment of: more than 15 mcg/min for norepinephrine and dopamine, more than 10 mcg/min in epinephrine; and more than 50 mcg/ min for phenylephrine. - Advanced lung disease confirmed by computed tomography findings - Presence or history of pneumothorax - Severe coagulopathy (INR = 4) - Severe thrombocytopenia (Platelets count = 5,000/mm3) - Usage of any devices with electric current generation such as pacemaker or internal cardiac defibrillator - Recent esophageal trauma or surgery - Known presence of esophageal varices - Pregnancy |
Country | Name | City | State |
---|---|---|---|
United States | Massachussets General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
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. — View Citation
ARDS Definition Task Force, Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669. — View Citation
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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. — View Citation
Borges JB, Okamoto VN, Matos GF, Caramez MP, Arantes PR, Barros F, Souza CE, Victorino JA, Kacmarek RM, Barbas CS, Carvalho CR, Amato MB. Reversibility of lung collapse and hypoxemia in early acute respiratory distress syndrome. Am J Respir Crit Care Med. 2006 Aug 1;174(3):268-78. Epub 2006 May 11. — View Citation
Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. Review. — View Citation
de Matos GF, Stanzani F, Passos RH, Fontana MF, Albaladejo R, Caserta RE, Santos DC, Borges JB, Amato MB, Barbas CS. How large is the lung recruitability in early acute respiratory distress syndrome: a prospective case series of patients monitored by computed tomography. Crit Care. 2012 Jan 8;16(1):R4. doi: 10.1186/cc10602. — View Citation
Demory D, Arnal JM, Wysocki M, Donati S, Granier I, Corno G, Durand-Gasselin J. Recruitability of the lung estimated by the pressure volume curve hysteresis in ARDS patients. Intensive Care Med. 2008 Nov;34(11):2019-25. doi: 10.1007/s00134-008-1167-8. Epub 2008 Jun 25. — View Citation
Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Böhm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5. Review. — View Citation
Fumagalli J, Berra L, Zhang C, Pirrone M, Santiago RRS, Gomes S, Magni F, Dos Santos GAB, Bennett D, Torsani V, Fisher D, Morais C, Amato MBP, Kacmarek RM. Transpulmonary Pressure Describes Lung Morphology During Decremental Positive End-Expiratory Pressure Trials in Obesity. Crit Care Med. 2017 Aug;45(8):1374-1381. doi: 10.1097/CCM.0000000000002460. — View Citation
Kacmarek RM, Villar J, Sulemanji D, Montiel R, Ferrando C, Blanco J, Koh Y, Soler JA, Martínez D, Hernández M, Tucci M, Borges JB, Lubillo S, Santos A, Araujo JB, Amato MB, Suárez-Sipmann F; Open Lung Approach Network. Open Lung Approach for the Acute Respiratory Distress Syndrome: A Pilot, Randomized Controlled Trial. Crit Care Med. 2016 Jan;44(1):32-42. doi: 10.1097/CCM.0000000000001383. — View Citation
Lachmann B. Open Lung in ARDS. Minerva Anestesiol. 2002 Sep;68(9):637-42; discussion 640, 643. Review. — View Citation
Lansdorp B, Hofhuizen C, van Lavieren M, van Swieten H, Lemson J, van Putten MJ, van der Hoeven JG, Pickkers P. Mechanical ventilation-induced intrathoracic pressure distribution and heart-lung interactions*. Crit Care Med. 2014 Sep;42(9):1983-90. doi: 10.1097/CCM.0000000000000345. — View Citation
Maggiore SM, Jonson B, Richard JC, Jaber S, Lemaire F, Brochard L. Alveolar derecruitment at decremental positive end-expiratory pressure levels in acute lung injury: comparison with the lower inflection point, oxygenation, and compliance. Am J Respir Crit Care Med. 2001 Sep 1;164(5):795-801. — View Citation
Matamis D, Lemaire F, Harf A, Brun-Buisson C, Ansquer JC, Atlan G. Total respiratory pressure-volume curves in the adult respiratory distress syndrome. Chest. 1984 Jul;86(1):58-66. — View Citation
Pinsky MR. My paper 20 years later: Effect of positive end-expiratory pressure on right ventricular function in humans. Intensive Care Med. 2014 Jul;40(7):935-41. doi: 10.1007/s00134-014-3294-8. Epub 2014 Apr 24. — View Citation
Pirrone M, Fisher D, Chipman D, Imber DA, Corona J, Mietto C, Kacmarek RM, Berra L. Recruitment Maneuvers and Positive End-Expiratory Pressure Titration in Morbidly Obese ICU Patients. Crit Care Med. 2016 Feb;44(2):300-7. doi: 10.1097/CCM.0000000000001387. — View Citation
Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2014 Mar 6;370(10):980. doi: 10.1056/NEJMc1400293. — View Citation
Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11. — View Citation
* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Chest wall and lung elastances (cmH2O/L) | This exploratory outcome represents the respiratory system elastance. The respiratory system elastance (ERS = EL + ECW) is the sum of lung elastance (EL) and chest wall (ECW) elastance. In order to measure ERS, we will need airway pressure (measured by connecting the endotracheal tube with a pressure transducer) and pleural pressure (measured by placing an esophageal balloon connected to a pressure transducer, the esophageal pressure is a surrogate of the pleural pressure). | 1h (Phase A: "PEEP ARDSnet"), 2h (Phase C: "PEEP LRM"), 24h and 48h after the beginning of the study procedures | |
Other | Dead space (%) | This exploratory outcome is the volume (as a percent) of a breath that does not participate in gas exchange.The measure will be made using infrared absorption technology by a mainstream analyzer positioned distally to the Y piece and connected to a capnogram. | 1h (Phase A: "PEEP ARDSnet"), 2h (Phase C: "PEEP LRM"), 24h and 48h after the beginning of the study procedures | |
Other | Right heart function (Transthoracic Echocardiography) | Exploratory outcome | 1h (Phase A: "PEEP ARDSnet"), 2h (Phase C: "PEEP LRM"), 24h and 48h after the beginning of the study procedures | |
Other | Gas distribution, gas content, end-expiratory lung volume (using Electrical Impedance Tomography) | Exploratory outcome | 1h (Phase A: "PEEP ARDSnet"), 2h (Phase C: "PEEP LRM"), 24h and 48h after the beginning of the study procedures | |
Other | Ventilation/perfusion matching (using Electrical Impedance Tomography) | Exploratory outcome | 1h (Phase A: "PEEP ARDSnet"), 2h (Phase C: "PEEP LRM"), 24h and 48h after the beginning of the study procedures | |
Other | Blood arterial and central venous pressures | Exploratory outcome | 1h (Phase A: "PEEP ARDSnet"), 2h (Phase C: "PEEP LRM"), 24h and 48h after the beginning of the study procedures | |
Other | Days free of mechanical ventilation | Exploratory outcome | 28 days | |
Other | ICU length of stay | Exploratory outcome | 28 days | |
Other | Hospital length of stay | Exploratory outcome | 28 days | |
Other | Mortality | Exploratory outcome | 28 days | |
Primary | Driving Pressure (cmH2O) | The primary endpoint of this study is to describe the airways driving pressures (defined as Plateau Pressure minus PEEP) during "PEEP ARDSnet" and "PEEP LRM". | 1h (Phase A: "PEEP ARDSnet") and 2h (Phase C: "PEEP LRM") after the beginning of the study procedures |
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