Gas eXchange eXtracorporeaL techniques: How many candidates in the ICU? The XXL Study
CCCF ePoster library. Sklar M. Oct 26, 2015; 117316; P3
Dr. Michael Sklar
Dr. Michael Sklar
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Abstract
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P3


Topic: Retrospective or Prospective Cohort Study


Gas eXchange eXtracorporeaL techniques: How many candidates in the ICU? The XXL Study



Michael Sklar, A. Lanys, L. Brochard, N. Ferguson, E. Fan

Anesthesia, University of Toronto, Toronto, Canada | Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Canada | Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Canada | Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Canada | Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Canada

Introduction: Extracorporeal life support (ECLS) is being used with increasing frequency and in diverse clinical situations in intensive care units (ICUs) around the world(1-8). High quality evidence does not yet exist for all indications, but strong physiological or preliminary data suggest possible benefits for a number of specific patient populations(1-14). ECLS techniques are also used as a bridge to, or after, heart or lung transplantation. In addition, newer extracorporeal devices using lower blood flows to enhance carbon dioxide elimination (extracorporeal CO2 removal [ECCO2R]) and to reduce the amount and intensity of mechanical ventilation delivered have been developed and deployed as a way to protect the lung, to avoid the need for intubation or to wean patients off the ventilator(14-16).

Objectives:

To evaluate the incidence of patients who may be candidates for the different forms of extracorporeal support in ICU.



Methods:

XXL will be a prospective observational study screening patients meeting criteria for ECLS. The study will run for 2 years, with data collection occurring over 12 months (to capture seasonally variability). We will perform this audit by leveraging existing infrastructure from the Toronto Intensive Care Observational Registry (iCORE) Project. This registry is performing uniform data collection in the adult teaching hospitals and will be implemented for in 3 large affiliated community hospitals

Current Indications for ECLS

ECMO is currently indicated in severe ARDS with PaO2/FiO2 ratio ≤ 100 mmHg despite optimal mechanical ventilation, as a bridge to lung transplant or post-lung transplant primary graft dysfunction, refractory cardiogenic shock despite optimal medical management and/or revascularization or as a bridge to heart transplant or post-heart transplant primary graft dysfunction.

Possible indications to be evaluated

ECMO

1. Severe ARDS as per EOLIA (ongoing RCT) criteria (with PaO2/FiO2 thresholds of less than 100 mmHg)

2. Refractory cardiogenic shock with left ventricular ejection fraction <40%, complicating myocardial infarction as per ANCHOR trial criteria

ECCO2R

1. Moderate ARDS as per SUPERNOVA (planned RCT) criteria using PaO2/FiO2 ratio at or below 200 mmHg

2. COPD exacerbation patients (14) receiving non-invasive ventilation at risk of intubation with PaCO2 > 50mmHg or pH ≤ 7.30, signs of respiratory distress, or intubated patients for facilitation of ventilator weaning

3. Patients with hypercapnic respiratory failure (e.g., asthma, decompensated chronic respiratory failure, obesity hypoventilation syndrome, cystic fibrosis) undergoing invasive mechanical ventilation with either: plateau pressure > 25cmH2O; PaCO2 > 50, and pH ≤ 7.30; intrinsic PEEP ≥ 7, other reasons for reducing ventilator intensity (e.g., hemodynamic instability [mean arterial pressure < 65 mmHg with inotropes/vasopressors], high risk of barotrauma [previous/current pneumothorax, hyperlucency on chest x-ray); or risk of bronchopleural fistula after lung surgery (< 3 days after surgery)

4. Patients with hypercapnic respiratory failure (e.g., asthma, decompensated chronic respiratory failure, obesity hypoventilation syndrome, cystic fibrosis) undergoing non-invasive ventilation having either: PaCO2 > 50mmHg or pH ≤ 7.30

5. Patients with bronchopleural fistula(e)




Results: We will evaluate the incidence of patients who may be candidates for the different forms of ECLS. We will also document the use of other adjunctive (rescue) interventions (e.g., prone positioning, inhaled vasodilators), potential barriers or facilitators to transfer patients, and any relative or absolute contraindications to the initiation of extracorporeal support. Other secondary outcomes include duration of ICU and hospital stay, outcome at ICU and hospital discharge.

Conclusion: The data generated from this project will directly inform the potential need for ECLS over the coming years, and allow for adequate and responsible planning and resources allocation with regards to ECLS across the Ontario.

References:

1. Combes A, Leprince P, Luyt CE, Bonnet N, Trouillet JL, Leger P, Pavie A, Chastre J. Outcomes and long-term quality-of-life of patients supported by extracorporeal membrane oxygenation for refractory cardiogenic shock. Critical care medicine 2008; 36: 1404-1411.

2. Dembitsky WP, Moreno-Cabral RJ, Adamson RM, Daily PO. Emergency resuscitation using portable extracorporeal membrane oxygenation. The Annals of thoracic surgery 1993; 55: 304-309.

3. Hubmayr RD, Farmer JC. Should we 'rescue' patients with 2009 influenza A(H1N1) and lung injury from conventional mechanical ventilation? Chest 2010; 137: 745-747.

4. Morris AH. Exciting new ECMO technology awaits compelling scientific evidence for widespread use in adults with respiratory failure. Intensive care medicine 2012; 38: 186-188.

5. Morris AH, Hirshberg E, Miller RR, 3rd, Statler KD, Hite RD. Counterpoint: Efficacy of extracorporeal membrane oxygenation in 2009 influenza A(H1N1): sufficient evidence? Chest 2010; 138: 778-781; discussion 782-774.

6. Peek GJ, Mugford M, Tiruvoipati R, Wilson A, Allen E, Thalanany MM, Hibbert CL, Truesdale A, Clemens F, Cooper N, Firmin RK, Elbourne D. Efficacy and economic assessment of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR): a multicentre randomised controlled trial. Lancet (London, England) 2009; 374: 1351-1363.

7. Pham T, Combes A, Roze H, Chevret S, Mercat A, Roch A, Mourvillier B, Ara-Somohano C, Bastien O, Zogheib E, Clavel M, Constan A, Marie Richard JC, Brun-Buisson C, Brochard L. Extracorporeal membrane oxygenation for pandemic influenza A(H1N1)-induced acute respiratory distress syndrome: a cohort study and propensity-matched analysis. Am J Respir Crit Care Med 2013; 187: 276-285.

8. Rastan AJ, Dege A, Mohr M, Doll N, Falk V, Walther T, Mohr FW. Early and late outcomes of 517 consecutive adult patients treated with extracorporeal membrane oxygenation for refractory postcardiotomy cardiogenic shock. The Journal of thoracic and cardiovascular surgery 2010; 139: 302-311, 311.e301.

9. Beiderlinden M, Eikermann M, Boes T, Breitfeld C, Peters J. Treatment of severe acute respiratory distress syndrome: role of extracorporeal gas exchange. Intensive care medicine 2006; 32: 1627-1631.

10. Brodie D, Bacchetta M. Extracorporeal Membrane Oxygenation for ARDS in Adults. New England Journal of Medicine 2011; 365: 1905-1914.

11. Chen YS, Chao A, Yu HY, Ko WJ, Wu IH, Chen RJ, Huang SC, Lin FY, Wang SS. Analysis and results of prolonged resuscitation in cardiac arrest patients rescued by extracorporeal membrane oxygenation. Journal of the American College of Cardiology 2003; 41: 197-203.

12. Combes A, Bacchetta M, Brodie D, Müller T, Pellegrino V. Extracorporeal membrane oxygenation for respiratory failure in adults. Current Opinion in Critical Care 2012; 18: 99-104.

13. Combes A, Brodie D, Bartlett R, Brochard L, Brower R, Conrad S, De Backer D, Fan E, Ferguson N, Fortenberry J, Fraser J, Gattinoni L, Lynch W, MacLaren G, Mercat A, Mueller T, Ogino M, Peek G, Pellegrino V, Pesenti A, Ranieri M, Slutsky A, Vuylsteke A. Position Paper for the Organization of Extracorporeal Membrane Oxygenation Programs for Acute Respiratory Failure in Adult Patients. American Journal of Respiratory and Critical Care Medicine 2014; 190: 488-496.

14. Sklar MC, Beloncle F, Katsios CM, Brochard L, Friedrich JO. Extracorporeal carbon dioxide removal in patients with chronic obstructive pulmonary disease: a systematic review. Intensive care medicine 2015.

15. Del Sorbo L, Pisani L, Filippini C, Fanelli V, Fasano L, Terragni P, Dell'Amore A, Urbino R, Mascia L, Evangelista A, Antro C, D'Amato R, Sucre MJ, Simonetti U, Persico P, Nava S, Ranieri VM. Extracorporeal Co2 removal in hypercapnic patients at risk of noninvasive ventilation failure: a matched cohort study with historical control. Critical care medicine 2015; 43: 120-127.

16. Roncon-Albuquerque R, Jr., Brodie D. Extracorporeal CO2 removal in severe chronic obstructive pulmonary disease exacerbations: a work in progress. Critical care medicine 2015; 43: e102-103.

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