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HIGH-FREQUENCY OSCILLATION: STATE OF THE EVIDENCE Niall D. Ferguson, MD, FRCPC, MSc Director, Critical Care Medicine University Health Network & Mount.

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Presentation on theme: "HIGH-FREQUENCY OSCILLATION: STATE OF THE EVIDENCE Niall D. Ferguson, MD, FRCPC, MSc Director, Critical Care Medicine University Health Network & Mount."— Presentation transcript:

1 HIGH-FREQUENCY OSCILLATION: STATE OF THE EVIDENCE Niall D. Ferguson, MD, FRCPC, MSc Director, Critical Care Medicine University Health Network & Mount Sinai Hospital Associate Professor of Medicine & Physiology Interdepartmental Division of Critical Care Medicine University of Toronto

2 Disclosures CareFusion, USA (equipment loan) Cardinal Health, Canada (equipment service)

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5 Slutsky & Tremblay AJRCCM 1998

6 ARDS Network High Stretch V T : 11.8 P PLAT : RR: 18 V MIN : 13 PEEP: 8 Mortality 40% Low Stretch V T : 6.2 ml/kg P PLAT : 25 cm H 2 O RR: 29 V MIN : 13 L/min PEEP: 9 cm H 2 O Mortality 31%* *p=0.005 N Engl J Med :1301-8

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8 Can We Reduce VILI Further?

9 HFO vs. Injurious CV in Animals

10 HFO vs. ‘protective’ CV in animals

11 Outcomes 30 Day Mortality HFOV: 37% CMV: 52% Absolute Risk Reduction: 15% Relative Risk Reduction: 29% p=0.102 p= d p= d HFOV in adults with ARDS appears safe and may improve outcome – more study is needed

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13 HFO

14 OSCILLATE TRIAL Niall D. Ferguson, MD, FRCPC, MSc Maureen O. Meade, MD, FRCPC, MSc For the OSCILLATE Investigators and The Canadian Critical Care Trials Group

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17 Research Question For critically ill adults with ARDS, does the early application of high frequency oscillation reduce hospital mortality compared to a high-PEEP, low tidal volume ventilation strategy that incorporates HFO exclusively as ‘rescue’ therapy?

18 Study Design International, multicentre randomized clinical trial Pilot randomized trial N = 94 Acceptability, feasibility Current randomized trial analysis includes 94 pilot study patients

19 Population Target: 1200 adults with moderate-severe ARDS Acute respiratory failure PaO 2 /FiO 2 < 200 Bilateral airspace disease on CXR Not attributed primarily to circulatory overload Standardized ventilator settings Vt 6 mL/kg PBW PEEP > 10 cm H 2 O FiO 2 > 0.60

20 Control Group High PEEP, Low V T Ventilation Based on the Lung Open Ventilation Study (JAMA ’08) Recruitment manoeuvre: 40 cm H 2 O x 40 seconds Initial settings FiO PEEP 20 cm H 2 O Pressure control mode V T 6 ml/kg PBW P PLAT ≤ 35 cm H 2 O

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22 Volume-Pressure Curve HFO VolumeVolumeVolumeVolume Pressure Lower Inflection Point Upper Infection Point

23 High Frequency Oscillatory Ventilation Recruitment manoeuvre: 40 cm H 2 O x 40 seconds Initial settings FiO mP AW 30 cm H 2 O Bias flow 40 L/min  P = 90 cm H 2 O f determined by baseline pH… pH 7.10 = 3.5 Hz pH = 4 Hz pH = 5 Hz pH >7.35 = 6 Hz

24 Oxygenation Protocols Control FiO PEEP HFO FiO mP AW % < SpO 2 < 93% 55 mm Hg < PaO 2 < 80 mmHg

25 Patient Safety Volume status assessment prior to initiation Rx hypotension with an increase in PEEP/mP AW with stable PEEP/mP AW Rx lung over-distention option to reduce PEEP/mP AW option to omit recruitment maneuvers Contraindications to recruitment maneuvers Criteria for instituting ‘rescue’ therapy 24-hour help line

26 Interim Analyses P ILOT S TUDY A NALYSIS N = 94 No stopping rules C ONVENTIONA L I NTERIM A NALYSIS N = 800 O’Brien-Fleming method; 2-sided test, p = 0.01 S AFETY R EVIEWS N = 300, 500, 700 physiologic changes with study initiation vasopressors, NMBAs, barotrauma detailed criteria for requesting mortality data 1-sided O’Brien-Fleming method; p = , ,

27 Patients July 2007 through August 2012 (1 year hiatus) Began in 12 pilot centers - expanded to total 39 centers Canada; United States; Saudi Arabia; Chile; India (Mexico; UK; Australia; France) The Steering Committee terminated the trial on recommendation from the DMC on August 29, 2012 Following the 500-patient safety analysis 548 of planned 1200 patients randomized

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30 Baseline Characteristics

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32 Transition on to Protocol

33 Ventilation Parameters Day 1 HFOVControl Delta P 87 (7.8) Frequency 5.5 (1) mPaw 31 (2.6)24 (4) VTVT 6.1 (1.3) PEEP 18 (3.2) P PLAT 32 (5.7) FIO2FIO (0.19)0.64 (0.20) PaO 2 84 (38)94 (52) PaCO 2 46 (15)52 (17) Fluid Balance 2897 (3124) 2410 (2901) Day 1 Day 3Day 7 HFOVControlHFOVControlHFOVControl Delta P 87 (7.8)85 (9.5)87 (7.3) Frequency 5.5 (1)6.8 (2) mPaw 31 (2.6)24 (4)26 (6.8)20 (6.4)21 (8.9)18 (7.1) VTVT 6.1 (1.3)6.6 (1.8)7.0 (1.8) PEEP 18 (3.2)13 (4.5)12 (4.6) P PLAT 32 (5.7)27 (8.1)24 (8.7) FIO2FIO (0.19)0.64 (0.20)0.50 (0.16)0.45 (0.14)0.45 (0.16)0.42 (0.16) PaO 2 84 (38)94 (52)78 (21)73 (18)76 (26)75 (23) PaCO 2 46 (15)52 (17)51 (15)46 (11)50 (17)47 (15) Fluid Balance 2897 (3124) 2410 (2901) 1519 (2430) 1147 (2486) -87 (2072) -215 (2298) Day 1 Day 3 HFOVControlHFOVControl Delta P 87 (7.8)85 (9.5) Frequency 5.5 (1)6.8 (2) mPaw 31 (2.6)24 (4)26 (6.8)20 (6.4) VTVT 6.1 (1.3)6.6 (1.8) PEEP 18 (3.2)13 (4.5) P PLAT 32 (5.7)27 (8.1) FIO2FIO (0.19)0.64 (0.20)0.50 (0.16)0.45 (0.14) PaO 2 84 (38)94 (52)78 (21)73 (18) PaCO 2 46 (15)52 (17)51 (15)46 (11) Fluid Balance 2897 (3124) 2410 (2901) 1519 (2430) 1147 (2486)

34 Ventilation Groups HFO Group 270/275 (98%) patients received HFO Median 3 (2-8) days of HFO 222 (81%) moved to conventional ventilation Median 5 (2-7) days of conventional Control Group All patients received conventional ventilation 34 (12.5%) converted to HFO after 2 (1-4) days Median 7 (5-15) days of HFO

35 Main Results

36 Survival Curve

37 All Subgroups

38 Cointerventions

39 Midazolam doses in week 1 HFOV 199 ( ) vs. Control 141 (68-240) mg/day; P<0.001

40 Opioid doses in week 1 HFOV 2980 ( ) vs. Control 2400 ( ) μg/day; P=0.06

41 Discussion Early application of HFOV associated with harm compared with a high PEEP, low V T strategy allowing HFOV only for severe refractory hypoxemia HFOV patients received higher mPaw, more sedatives, more NMBAs, more vasoactive drugs Subgroup analysis suggest that this finding is robust across severity and experience of groups Studies that stop early often overestimate effects No benefit of HFOV Possibly because we used a more effective control strategy Harm with HFOV? Chance Higher mPaw leading to hemodynamic compromise Hemodynamic effects of increased sedatives Possible increased barotrauma and VILI

42 Discussion HFOV strategy chosen based on preclinical data and pilot physiological data Resulted in relatively high mPaw Other HFOV strategies using lower mPaw may have different effects Implications for care Results raise serious concerns about use of early HFOV for adults with moderate-severe ARDS Even for those with refractory hypoxemia, results increase uncertainty about possible benefits of HFOV

43 Conclusions HFOV as used in the OSCILLATE trial does not improve survival and is likely harmful compared with a high PEEP, low tidal volume conventional strategy allowing HFOV only as rescue therapy

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46 30-Day Mortality: HFO 41.7% vs. 41.1% Hospital Mortality: HFO 50.1% vs. 48.4%

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49 November 10-13, 2013 Sheraton Centre Hotel, Toronto


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