OSCAR & OSCILLATE. & the Future of High Frequency Oscillatory Ventilation (HFOV)
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1 & & the Future of High Frequency Oscillatory Ventilation (HFOV)
2 What do we know already? Sud S et al. BMJ 2010
3 & Multi-centre randomised controlled trials of HFOV verses current ventilation practice in adults with ARDS
4 n = 795 (1006 intended) n = 548 (1200 intended) 29 centres 39 centres Expert and non-expert centres Expert and non-expert centres England, Scotland and Wales Canada, USA, Saudi, Chile and India Day mortality, - days of paralysis, sedation, vasopressors, and antibiotics, duration of treatment in ICU and hospital 60 Day mortality - total dose of paralysis and sedation, vasopressors, duration of treatment in ICU and hospital
5 Inclusion Respiratory failure Intubated for less than 7 days since onset of failure Intubated within 2 weeks of onset of failure Expected to need ventilation for more than 2 days Hypoxaemia PEEP 5 mmhg PaO2:FiO2 200 Radiology Bilateral air space opacification on chest X ray Age
6 Exclusion Evidence of right atrial hypertension Suspected vascular pulmonary haemorrhage Neuromuscular disorders known to prolong MV Lung disease characterised by airway narrowing or air trapping Weight < 35 Kg Recent lung surgery Severe chronic respiratory disease Weight < 35 Kg or > 1 Kg per cm height Pre-existing conditions with > 50% 1 year mortality Participating in other trial
7 Control Stipulation Usual practice with guidance Strict protocol Recruitment none 40 s of 40 mmhg Mode PCV Vt 6 8 ml/kg IBW 6 ml/kg IBW PEEP Titrated to FiO2 Pplat Spont breaths < 35 mmhg Daily trial Rescue HFOV At physicians discretion Yes with clear indications
8 Intervention Recruitment Ventilator Novalung R100 (Metran) 40 s of 40 mmhg Sensor Medics 3100B (CareFusion) PMaw 5 cmh2o > Pplat 30 cmh2o PaO mmhg mmhg f 10 Hz then ph Hz then ph 7.2 I:E 1:1 1:2 Bias flow 100 ml
9 Exit from HFOV 12 hours of: - FiO PaO2 60 mmhg - PMaw 24 cmh2o Restart HFOV up to 2 days later
10 Randomisation Allocation Independent telephone randomisation system Central web-based randomisation system Stratification PaO2:FiO2 ratio, sex, age, centre Blocks of 2 or 4 centre Baseline Slight advantage to intervention (age) Slight intervention to control (age and inotropes)
11 Blinding Treatment - No blinding Analysis - Unclear Outcomes are objective
12 Results: Follow Up 100% on intention to treat - 2.5% of control arm received rescue HFOV - 2.5% of intervention arm died before HFOV could be commenced 97.5% intervention vs 2.5% control received HFOV median duration of 3 days (IQR 2 5) 100% on intention to treat - 12% of control arm received rescue HFOV - 1.5% of intervention arm didn t receive HFOV 98% intervention vs 12% control received HFOV median duration of 3 days (IQR 2 8)
13 Cross Over Pre planed conditions for rescue therapy including HFOV - Refractory hypoxaemia (PaO2 60 mmhg with FiO2 of 1.0 with neuromuscular blockade) - Refractory barotrauma (persistent pneumothorax or increasing subcutaneous emphysema despite two intercostal catheters on the involved side) - Refractory acidosis (ph 7.05 despite neuromuscular blockade) 12% crossed over to HFOV (91% according to protocol) Average duration of rescue HFOV was 7 days Mortality 71% in the crossed over patients Maximum number of patients that might have been saved was 10 (3.5%)
14 Primary Outcomes 30 Day mortality 60 Day mortality Control HFOV Control HFOV 166 (41.7%) 163 (41.1%) 96 (35%) 129 (47%) (P = 0.85) (P = 0.005) Stopped early for futility Relative risk of death in the HFOV cohort 1.33 (CI ) Stopped early for risk of harm
15 Results
16 Results
17 Multivariate Analysis on 60 Day Mortality No significant association with - Baseline hypoxia - Respiratory compliance - BMI - Vasopressors - Treatment centre experience
18 Secondary Outcomes Intervention vs Control Midazolam: 199 mg vs 144 mg (P<0.001) Sedation 9.4 vs 8.5 days Fentanyl: 2980 μg vs 2400 μg (P=0.06) NMJ blockade 2.5 vs 2.0 days 98% vs 63% (P<0.001) Vasopressors 2.9 days vs 2.8 days 91% vs 84% (P=0.01) Antibiotics 12.8 vs 12.4 days Refractory hypoxia 7% vs 14% (P=0.007)
19 The Future for HFOV Dubious
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