Ultra Protective Ventilation During Venoarterial Extracorporeal Membrane Oxygenation (UPV-ECMO) (UPV-ECMO)

• ClinicalTrials.gov Identifier: NCT03041428
• Recruitment Status: Active, not recruiting
• First Posted: February 2, 2017
• Last Update Posted: January 18, 2020
• Sponsor: Fundación para la Investigación Biosanitaria del Principado de Asturias
• Information provided by (Responsible Party): Fundación para la Investigación Biosanitaria del Principado de Asturias

Study Description

Brief Summary:

Mechanical ventilation, in spite of being a life-saving technique, can also induce lung injury (VILI) mediated by an inflammatory response, thus having a profound impact in the course of critically ill patients. Ventilatory strategies aimed to minimize this VILI have reduced mortality rates. Patients suffering cardiogenic pulmonary edema may need venoarterial extracorporeal oxygenation, at the same time they are being mechanically ventilated. The objective of this study is to analyze changes induced by the use of utraprotective ventilatory strategies in the inflammatory lung response of these patients and their impact on outcomes.

Condition or disease	Intervention/treatment	Phase
Cardiogenic Pulmonary Edema; Ventilator-Induced Lung Injury; Extracorporeal Circulation; Complications	Device: Ultraprotective ventilation	Not Applicable

Detailed Description:

Mechanical ventilation is the cornerstone of the critically-ill patients support, providing better gas exchange conditions while respiratory muscles rest. Providing this life-support technique may be harmful on the lung tissue, last decades research efforts were focused on minimizing the ventilator-induced lung injury (VILI). Knowledge regarding the mechanisms of this injury has led to changes in the clinical practice, consisting on the application of positive end-expiratory pressure (PEEP) and the use of low tidal volumes, giving rise to the strategy known as "protective ventilation". Moreover, the use of extracorporeal membrane oxygenation (ECMO) techniques contributes to maintaining an adequate gas exchange until lung damage resolution. A tidal volume in the range of 6 ml/Kg of ideal body weight, with a reasonable level of PEEP is the standard of care for patients with the ARDS. However, optimal levels of tidal volume and PEEP have not been completely established. On the other side, decreasing tidal volume below 6 ml/Kg faces its own problems. The role of the so-called "ultraprotective" approaches, in which extracorporeal support is required to reduce tidal volumes up to 3 ml/kg or less, although feasible, is currently under research. During venoarterial ECMO, blood is removed from the vessels and pumped through a circuit where is oxygenated and CO2 is removed; finally, the blood is returned to the arterial circulation. The development of new circuits and devices made this therapy become safer and more useful, improving outcomes so that its application has been widespread to many centers all over the world. One of the ECMO advantages is carbon dioxide removal, which allows reducing tidal volume below 6 ml/kg. Ultraprotective strategies with 3 ml/kg have demonstrated to be feasible, but the additional benefit of this strategy is to be demonstrated. Therefore, in this study, patients suffering cardiogenic pulmonary edema requiring ECMO and mechanical ventilation are submitted to an ultraprotective ventilator strategy. Lung inflammatory response is measured before and after the intervention, in order to evaluate its impact in this subset of patients.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Effect of Ultraprotective Ventilation on the Lung Inflammatory Response in Patients With Acute Pulmonary Edema Treated With Venoarterial Extracorporeal Oxygenation
• Actual Study Start Date: February 1, 2017
• Actual Primary Completion Date: December 31, 2019
• Estimated Study Completion Date: December 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Recruited patients; Ultraprotective ventilation	Device: Ultraprotective ventilation; Adjusting ventilator parameters for 3 ml/kg of tidal volume in order to achieve the ultra protective strategy

Outcome Measures

Primary Outcome Measures :

1. Change in lung inflammatory mediators levels [ Time Frame: Baseline and 18 hours after the intervention ]
   Bronchoalveolar lavage cytokines levels, measured in ng/ml

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Cardiogenic pulmonary edema supported by venoarterial extracorporeal membrane oxygenation.
• Invasive mechanical ventilatory support under sedation.

Exclusion Criteria:

• Immunosupresion.
• Hemodynamic instability refractory to mechanical support, conditioning an end-of-life approach and terminal situation.

Contacts and Locations

Locations

Spain

Hospital Universitario Central de Asturias (HUCA)

Oviedo, Principado De Asturias, Spain, 33011

Sponsors and Collaborators

Fundación para la Investigación Biosanitaria del Principado de Asturias

Investigators

• Principal Investigator: Guillermo M Albaiceta; HUCA-FINBA, Universidad de Oviedo

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.

Leligdowicz A, Fan E. Extracorporeal life support for severe acute respiratory distress syndrome. Curr Opin Crit Care. 2015 Feb;21(1):13-9. doi: 10.1097/MCC.0000000000000170. Review.

Determann RM, Royakkers A, Wolthuis EK, Vlaar AP, Choi G, Paulus F, Hofstra JJ, de Graaff MJ, Korevaar JC, Schultz MJ. Ventilation with lower tidal volumes as compared with conventional tidal volumes for patients without acute lung injury: a preventive randomized controlled trial. Crit Care. 2010;14(1):R1. doi: 10.1186/cc8230. Epub 2010 Jan 7.

Terragni PP, Rosboch G, Tealdi A, Corno E, Menaldo E, Davini O, Gandini G, Herrmann P, Mascia L, Quintel M, Slutsky AS, Gattinoni L, Ranieri VM. Tidal hyperinflation during low tidal volume ventilation in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2007 Jan 15;175(2):160-6. Epub 2006 Oct 12.

Figueroa-Casas JB, Montoya R. Effect of Tidal Volume Size and Its Delivery Mode on Patient-Ventilator Dyssynchrony. Ann Am Thorac Soc. 2016 Dec;13(12):2207-2214.

Bein T, Weber-Carstens S, Goldmann A, Müller T, Staudinger T, Brederlau J, Muellenbach R, Dembinski R, Graf BM, Wewalka M, Philipp A, Wernecke KD, Lubnow M, Slutsky AS. Lower tidal volume strategy (≈3 ml/kg) combined with extracorporeal CO2 removal versus 'conventional' protective ventilation (6 ml/kg) in severe ARDS: the prospective randomized Xtravent-study. Intensive Care Med. 2013 May;39(5):847-56. doi: 10.1007/s00134-012-2787-6. Epub 2013 Jan 10.

Fan E, Gattinoni L, Combes A, Schmidt M, Peek G, Brodie D, Muller T, Morelli A, Ranieri VM, Pesenti A, Brochard L, Hodgson C, Van Kiersbilck C, Roch A, Quintel M, Papazian L. Venovenous extracorporeal membrane oxygenation for acute respiratory failure : A clinical review from an international group of experts. Intensive Care Med. 2016 May;42(5):712-724. doi: 10.1007/s00134-016-4314-7. Epub 2016 Mar 23. Review.

Schmidt M, Stewart C, Bailey M, Nieszkowska A, Kelly J, Murphy L, Pilcher D, Cooper DJ, Scheinkestel C, Pellegrino V, Forrest P, Combes A, Hodgson C. Mechanical ventilation management during extracorporeal membrane oxygenation for acute respiratory distress syndrome: a retrospective international multicenter study. Crit Care Med. 2015 Mar;43(3):654-64. doi: 10.1097/CCM.0000000000000753.

• Responsible Party: Fundación para la Investigación Biosanitaria del Principado de Asturias
• ClinicalTrials.gov Identifier: NCT03041428
• Other Study ID Numbers: FINBA_CritLab_1
• First Posted: February 2, 2017
• Last Update Posted: January 18, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Lung Injury; Pulmonary Edema; Ventilator-Induced Lung Injury; Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries