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

NCT03041428 | Completed

• 1 other identifier: FINBA_CritLab_1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiogenic Pulmonary Edema; Ventilator-Induced Lung Injury; Extracorporeal Circulation; Complications

Outcome Measures

Primary Outcomes (1)

• Change in lung inflammatory mediators levels

  Bronchoalveolar lavage cytokines levels, measured in ng/ml

  Baseline and 18 hours after the intervention

Study Arms (1)

Recruited patients

EXPERIMENTAL

Ultraprotective ventilation

Device: Ultraprotective ventilation

Interventions

Ultraprotective ventilation DEVICE

Adjusting ventilator parameters for 3 ml/kg of tidal volume in order to achieve the ultra protective strategy

Recruited patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fundación para la Investigación Biosanitaria del Principado de Asturias: lead

Study Sites (1)

Hospital Universitario Central de Asturias (HUCA)

Oviedo, Principality of Asturias, 33011, Spain

Location

Related Publications (9)

• 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.

  PMID: 10793162 BACKGROUND

• 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.

  PMID: 25517890 BACKGROUND

• 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.

  PMID: 20055989 BACKGROUND

• 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. doi: 10.1164/rccm.200607-915OC. Epub 2006 Oct 12.

  PMID: 17038660 BACKGROUND

• 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. doi: 10.1513/AnnalsATS.201605-362OC.

  PMID: 27598383 BACKGROUND

• Bein T, Weber-Carstens S, Goldmann A, Muller 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 ( approximately 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.

  PMID: 23306584 BACKGROUND

• 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.

  PMID: 27007108 BACKGROUND

• 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.

  PMID: 25565460 BACKGROUND

• Amado-Rodriguez L, Del Busto C, Lopez-Alonso I, Parra D, Mayordomo-Colunga J, Arias-Guillen M, Albillos-Almaraz R, Martin-Vicente P, Lopez-Martinez C, Huidobro C, Camporota L, Slutsky AS, Albaiceta GM. Biotrauma during ultra-low tidal volume ventilation and venoarterial extracorporeal membrane oxygenation in cardiogenic shock: a randomized crossover clinical trial. Ann Intensive Care. 2021 Aug 28;11(1):132. doi: 10.1186/s13613-021-00919-0.

  PMID: 34453620 DERIVED

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Guillermo M Albaiceta

  HUCA-FINBA, Universidad de Oviedo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 2, 2017
• Study Start: February 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: March 1, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 3 months after publication.
• Access Criteria: Principal investigators will review requests of data to be provided.

Locations

ES (1)