Lung-protective ventilation initiated in the emergency department (LOV-ED): a study protocol for a quasi-experimental, before-after trial aimed at reducing pulmonary complications

Brian M Fuller, Ian Ferguson, Nicholas M Mohr, Robert J Stephens, Cristopher C Briscoe, Angelina A Kolomiets, Richard S Hotchkiss, Marin H Kollef, Brian M Fuller, Ian Ferguson, Nicholas M Mohr, Robert J Stephens, Cristopher C Briscoe, Angelina A Kolomiets, Richard S Hotchkiss, Marin H Kollef

Abstract

Introduction: In critically ill patients, acute respiratory distress syndrome (ARDS) and ventilator-associated conditions (VACs) are associated with increased mortality, survivor morbidity and healthcare resource utilisation. Studies conclusively demonstrate that initial ventilator settings in patients with ARDS, and at risk for it, impact outcome. No studies have been conducted in the emergency department (ED) to determine if lung-protective ventilation in patients at risk for ARDS can reduce its incidence. Since the ED is the entry point to the intensive care unit for hundreds of thousands of mechanically ventilated patients annually in the USA, this represents a knowledge gap in this arena. A lung-protective ventilation strategy was instituted in our ED in 2014. It aims to address the parameters in need of quality improvement, as demonstrated by our previous research: (1) prevention of volutrauma; (2) appropriate positive end-expiratory pressure setting; (3) prevention of hyperoxia; and (4) aspiration precautions.

Methods and analysis: The lung-protective ventilation initiated in the emergency department (LOV-ED) trial is a single-centre, quasi-experimental before-after study testing the hypothesis that lung-protective ventilation, initiated in the ED, is associated with reduced pulmonary complications. An intervention cohort of 513 mechanically ventilated adult ED patients will be compared with over 1000 preintervention control patients. The primary outcome is a composite outcome of pulmonary complications after admission (ARDS and VACs). Multivariable logistic regression with propensity score adjustment will test the hypothesis that ED lung-protective ventilation decreases the incidence of pulmonary complications.

Ethics and dissemination: Approval of the study was obtained prior to data collection on the first patient. As the study is a before-after observational study, examining the effect of treatment changes over time, it is being conducted with waiver of informed consent. This work will be disseminated by publication of full-length manuscripts, presentation in abstract form at major scientific meetings and data sharing with other investigators through academically established means.

Trial registration number: NCT02543554.

Keywords: ACCIDENT & EMERGENCY MEDICINE; ARDS; mechanical ventilation; ventilator-associated conditions.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Figures

Figure 1
Figure 1
Schematic of before-after trial design.
Figure 2
Figure 2
ED protocol for mechanical ventilation in the immediate postintubation period. ARDS, acute respiratory distress syndrome; ED, emergency department; PBW, predicted body weight; PEEP, positive end-expiratory pressure; BMI, body mass index; FiO2, fraction of inspired oxygen; SpO2, peripheral oxygen saturation; PaO2, partial pressure of arterial oxygen; iPEEP, intrinsic PEEP.
Figure 3
Figure 3
Planned operations for intervention study period (after group). ED, emergency department; ICU, intensive care unit; LOS, length of stay; VAC, ventilator-associated condition; ARDS, acute respiratory distress syndrome.

References

    1. Boyer AF, Schoenberg N, Babcock H et al. . A prospective evaluation of ventilator-associated conditions and infection-related ventilator-associated conditions. Chest 2015;147:68–81. 10.1378/chest.14-0544
    1. Fuller BM, Mohr NM, Drewry AM et al. . Lower tidal volume at initiation of mechanical ventilation may reduce progression to acute respiratory distress syndrome-a systematic review. Crit Care 2013;17:R11 10.1186/cc11936
    1. Rubenfeld GD, Caldwell E, Peabody E et al. . Incidence and outcomes of acute lung injury. N Engl J Med 2005;353:1685–93. 10.1056/NEJMoa050333
    1. Easter BD, Fischer C, Fisher J. The use of mechanical ventilation in the ED. Am J Emerg Med 2012;30:1183–8. 10.1016/j.ajem.2011.09.008
    1. Dreyfuss D, Soler P, Basset G et al. . High inflation pressure pulmonary edema: respective effects of high airway pressure, high tidal volume, and positive end-expiratory pressure. Am Rev Respir Dis 1988;137:1159–64. 10.1164/ajrccm/137.5.1159
    1. Webb HH, Tierney DF. Experimental pulmonary edema due to intermittent positive pressure ventilation with high inflation pressures. Protection by positive end-expiratory pressure. Am Rev Respir Dis 1974;110:556–65. 10.1164/arrd.1974.110.5.556
    1. No authors listed]. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. The Acute Respiratory Distress Syndrome Network. N Engl J Med 2000;342:1301–8. 10.1056/NEJM200005043421801
    1. Determann RM, Royakkers A, Wolthuis EK et al. . 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:R1 10.1186/cc8230
    1. Serpa Neto A, Cardoso SO, Manetta JA et al. . Association between use of lung-protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory distress syndrome: a meta-analysis. JAMA 2012;308:1651–9. 10.1001/jama.2012.13730
    1. Futier E, Constantin JM, Paugam-Burtz C et al. . A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med 2013;369:428–37. 10.1056/NEJMoa1301082
    1. Gajic O, Dara SI, Mendez JL et al. . Ventilator-associated lung injury in patients without acute lung injury at the onset of mechanical ventilation. Crit Care Med 2004;32:1817–24. 10.1097/01.CCM.0000133019.52531.30
    1. Gajic O, Frutos-Vivar F, Esteban A et al. . Ventilator settings as a risk factor for acute respiratory distress syndrome in mechanically ventilated patients. Intensive Care Med 2005;31:922–6. 10.1007/s00134-005-2625-1
    1. Jia X, Malhotra A, Saeed M et al. . Risk factors for ARDS in patients receiving mechanical ventilation for > 48 h*. Chest 2008;133:853–61. 10.1378/chest.07-1121
    1. Yilmaz M, Keegan MT, Iscimen R et al. . Toward the prevention of acute lung injury: protocol-guided limitation of large tidal volume ventilation and inappropriate transfusion*. Crit Care Med 2007;35:1660–6; quiz 1667 10.1097/01.CCM.0000269037.66955.F0
    1. Mascia L, Zavala E, Bosma K et al. . High tidal volume is associated with the development of acute lung injury after severe brain injury: an international observational study*. Crit Care Med 2007;35:1815–20. 10.1097/01.CCM.0000275269.77467.DF
    1. Pasero DDA, Guerriero F, Rana N et al. . High tidal volume as an independent risk factor for acute lung injury after cardiac surgery. Intensive Care Med 2008;34(Suppl1):0398.
    1. Fuller BM, Mohr NM, Dettmer M et al. . Mechanical ventilation and acute lung injury in emergency department patients with severe sepsis and septic shock: an observational study. Acad Emerg Med 2013;20:659–69. PMCID: PMC3718493 10.1111/acem.12167
    1. Fuller BM, Mohr NM, Miller CN et al. . Mechanical ventilation and acute respiratory distress syndrome in the emergency department: a multi-center, observational, prospective, cross-sectional, study. Chest 2015;148:365–74. 10.1378/chest.14-2476
    1. Dettmer MR, Mohr NM, Fuller BM. Sepsis-associated pulmonary complications in emergency department patients monitored with serial lactate: an observational cohort study. J Crit Care 2015;30:1163–8. 10.1016/j.jcrc.2015.07.031
    1. Kahn JM, Andersson L, Karir V et al. . Low tidal volume ventilation does not increase sedation use in patients with acute lung injury*. Crit Care Med 2005;33:766–71. 10.1097/01.CCM.0000157786.41506.24
    1. Kilickaya O, Gajic O. Initial ventilator settings for critically ill patients. Crit Care 2013;17:123 10.1186/cc12516
    1. Wolthuis EK, Veelo DP, Choi G et al. . Mechanical ventilation with lower tidal volumes does not influence the prescription of opioids or sedatives. Crit Care 2007;11:R77 10.1186/cc5969
    1. Gong MN, Ferguson ND. Lung-protective ventilation in acute respiratory distress syndrome. How soon is now? Am J Respir Crit Care Med 2015;191:125–6. 10.1164/rccm.201412-2250ED
    1. Ranieri VM, Rubenfeld GD, Thompson BT et al. , The ARDS definition task force. Acute respiratory distress syndrome. JAMA 2012;307:2526–33. 10.1001/jama.2012.5669
    1. Gajic O, Dabbagh O, Park PK et al. . Early identification of patients at risk of acute lung injury. Am J Respir Crit Care Med 2011;183:462–70. 10.1164/rccm.201004-0549OC
    1. Ferguson ND, Fan E, Camporota L et al. . The Berlin definition of ARDS: an expanded rationale, justification, and supplementary material. Intensive Care Med 2012;38:1573–82. 10.1007/s00134-012-2682-1
    1. The Society of Critical Care Medicine and The Johns Hopkins University School of Medicine. Sepsis without walls: ensuring all patients receive optimal, time-sensitive care. Baltimore, Maryland, USA: 25 September 2015. Live Event.
    1. Herring AA, Ginde AA, Fahimi J et al. . Increasing critical care admissions from US emergency departments, 2001–2009*. Crit Care Med 2013;41:1197–204. 10.1097/CCM.0b013e31827c086f
    1. Needham DM, Bronskill SE, Calinawan JR et al. . Projected incidence of mechanical ventilation in Ontario to 2026: preparing for the aging baby boomers*. Crit Care Med 2005;33:574–9. 10.1097/01.CCM.0000155992.21174.31
    1. Hung SC, Kung CT, Hung CW et al. . Determining delayed admission to intensive care unit for mechanically ventilated patients in the emergency department. Crit Care 2014;18:485 10.1186/s13054-014-0485-1
    1. Needham DM, Yang T, Dinglas VD et al. . Timing of low tidal volume ventilation and intensive care unit mortality in acute respiratory distress syndrome. A Prospective Cohort Study. Am J Respir Crit Care Med 2015;191:177–85. 10.1164/rccm.201409-1598OC
    1. Needham DM, Colantuoni E, Mendez-Tellez PA et al. . Lung protective mechanical ventilation and two year survival in patients with acute lung injury: prospective cohort study. BMJ 2012;344:e2124.
    1. Jones AE, Kline JA. Use of goal-directed therapy for severe sepsis and septic shock in academic emergency departments. Crit Care Med 2005;33:1888–9. 10.1097/01.CCM.0000166872.78449.B1

Source: PubMed

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