INTELLiVENT -ASV insight Alexandra Geiger CAS, Dr. Marc Wysocki, Head of Medical Research Hamilton Medical
First Automation of HAMILTON MEDICAL 1998 Adaptive Support Ventilation (ASV) ASV optimize VT and RR (Minimal work of breathing) (R, C, RCexp) Selects an individualised breath pattern Limits intrinsic PEEP
Clinical evidence for ASV Minimizes ventilation time Keep P plateau in a safe zone Adjustment of VT on ARDS Patients Optimal VT and RR Sultzer Anesthesiology 2001 Petter Anesth Analgesia 2003 Gruber Anesthesiology 2008 Dongelmanns Anesthesia Analgesia 2009 Campbell Respir Care 1998 Iotti Intensive Care Med 2010 Sulemanji Anesthesiology 2009 Gruber Anesthesiology 2008 Sulemanji Anesthesiology 2009 Arnal Intensive Care Med 2007 Arnal Intensive Care Med 2006 [abstract] Iotti Intensive Care Med 2010 Improved Patienten-Ventilator Interaction Dalmas Crit Care Med 2002 Randomised Multicenter Studien
ASV: Randomised Control studies 36 Post CABG Patients: 16 ASV 20 controls 34 post CABG Patients : 18 ASV 16 controls 48 post CABG Patients : 23 ASV 25 controls 121 post CABG Patients : 60 ASV 61 controls Sultzer et al. Anesthesiology 2001;95:1339-45 Petter et al. Anesth Analg 2003;97:1743-50 Gruber et al. Anesthesiology 2008;109:81 7 Dongelmans et al. Anesth Analg 2009;108:565-71 TOTAL: 239 post CABG Patients : 117 ASV 122 controls
ASV: Randomised Control studies settings Control group ASV Sultzer 2001 SIMV12 then PSV 10 5 MV 100% - 50% - 25% Petter 2003 SIMV@ 38<PaCO2<50 then PSV 10 5 MV @ 38<PaCO2<50 Gruber 2008 PRVC @ 38<PaCO2<50 MV @ 38<PaCO2<50 Dongelmans 2009 PCV @ 25<PaCO2<41 then PSV 10 5 MV @ 25<PaCO2<41
ASV: Randomised Control Studies Duration Dauer der B. (h) Controlled ASV % changes Sultzer 2001 4,0 3,2-20 Petter 2003 3,2 2,7-15 Gruber 2008 8,0 2,7-66 Dongelmans 2009 16,3 16,2-0,6 MEAN 8 + 6 6 + 6-20%
ASV: Randomised Control Studies Further results Sultzer et al. Anesthesiology 2001;95:1339-45 More patients extubated @ h+6 = faster weaning with ASV Less settings and alarms = ease of use Lower vt and Ppeak = safer PaCO2 lower = favorable breath pattern with ASV Petter et al. Anesth Analg 2003;97:1743-50 Gruber et al. Anesthesiology 2008;109:81 7 Dongelmans et al. Anesth Analg 2009;108:565-71
Lower VT and P plateau with ASV Tidal Volume (ml/kg) 9 8 7 6 * * PRVC (n = 25) ASV (n = 23) Plateau Pressure (cmh2o) 30 25 20 15 10 5 * * 5 Controlled ventilation Assisted ventilation 0 Controlled ventilation Assisted ventilation Gruber, Anesthesiology 2008
ASV Better than 6 ml/kg? P plat (cmh2o) ASV ARDS net ASV ARDS net 40 ASV ARDS net ASV ARDS net 30 30 60 Kg 80 Kg 60 Kg 80 Kg Suleymanci D, Wysocki M, Kacmarek R. Anesthesiology 2009
ASV Better than 6 ml/kg? Tidal Volume (ml/kg) 8 6 VT = 6 ml/kg 4 Normal Compliance Normal Resistance Low Compliance High Resistance Suleymanci D, Wysocki M, Kacmarek R. Anesthesiology 2009
Complete closed-loop ventilation- A dream?
INTELLiVENT -ASV HAMILTON-S1 The first complete closed loop ventilation solution for oxygenation and ventilation covering all applications from intubation until extubation with the known simplicity from HAMILTON MEDICAL
INTELLiVENT -ASV in practise Worldwide studies: more than 120 Patients have succesfully been ventilated withintellivent - ASV Not one Patient had to be switched to another mode
How does it work? INTELLiVENT -ASV?
Today: Adaptive Support Ventilation (ASV) Still 3 knobs Adaptive Support Ventilation (ASV) is: A proven Auto-Pilot (Closed Loop Ventilation) Works from intubation to extubation Automates lung-protective-strategies Promotes a favorable breath-pattern Encourages automatic early weaning Tasseaux, Crit Care Med 2002 Belliato, Int J Artif Organs 2004 Arnal, Intensive Care Med 2008 Jaber, Anesthesiology 2008 Cassina, J Cardiothorac Vasc Anesth 2003 Peter, Anesthesia Anagelsia 2003 Sultzer, Anesthesiology 2001 Gruber, Anesthesiology 2008 Sulemanji, Anesthesiology 2009
Patents pending IntelliVent-ASV IntelliVent ASV FULLY AUTOMATIC
INTELLiVENT -ASV Overvue MinVol ASV automates on EtCO2 and RR (R, C) PEEP & FiO2 automates on SpO2 PEEP - FiO2 protocols: ARDSnet Table Open Lung Protocol PEEP Limitation (user) + Hemodynamic Unique graphical user Interface
Practical examples - what would you do? 1. Hypercapnia etco2 = 55 mmhg Ppeak = 18 mbar 2. Hypocapnia etco2 = 35 mmhg Ppeak = 18 mbar?? Ventilation increase MV! Ventilation decrease MV! 3. Hyperoxygenation SpO2 = 99% FiO2 = 80% PEEP = 12 mbar 4. Hypooxygenation SpO2 = 93% FiO2 = 60% PEEP = 8 mbar? Oxygenation FiO2 decrease!? Oxygenation PEEPincrease.!
INTELLiVENT -ASV Ventilation Therapy decrease Therapy increase
INTELLiVENT -ASV Ventilation regulates etco2 in acceptable zone Ventilator support etco2 too low Reduce therapy etco2 too high Increase Therapy etco2
INTELLiVENT -ASV Ventilation Permissive Hypercapnia Ventilator Support Reduce Therapy Increase Therapy etco2
INTELLiVENT -ASV VentilationHorizon Info Status Support Limits Controller
INTELLiVENT -ASV VentilationHorizon decreae Increase
INTELLiVENT -ASV Oxygenation Therapy stable Increase Therapy Decreae therapy EMERGENCY FiO2 100%
INTELLiVENT -ASV OxygenationHorizon Info Status Support Limits Controller
FiO2 and PEEP Increase ARDSnet Guidelines Increase Therapy Increase PEEP Increase FiO2
FiO2 and PEEP Decrease OpenLung Concept Decrease therapy Decrease FiO2 Decrease PEEP
FiO2 and PEEP ARDSnet Guideline for Therapy Increase OpenLung Concept for Therapy Decrease Therapy decrease Therapy increase
Ventilation controller: PUSH TO WEAN If FiO2 < 40% and PEEP < 8 cmh2o and EtCO2 within acceptable ranges for 25 minutes: 5 minutes PUSH TO WEAN trial 70 90 75 95 30 55 65 30 60 70 25 35 41 25 40 46 35 41 40 46
Oxygenation controller: PUSH TO WEAN If SpO2 within acceptable ranges AND Patient above the line AND FiO2 automatic for > 60 minutes AND No PEEP changes in the last 30 minutes Reduce FiO2 stepwise
INTELLiVENT-ASV: PEEP/FiO2 Who manages to reduce FiO2 this fast? (38% O2 Reduction in 5 min) 5 min
Ventilation CockpitTM
INTELLiVENT -ASV Based on proven technology (SpO2 / EtCO2) Based on clinical evidence Based on well accepted protocols (ARDSnet) Flexible (Manual or Automatic)
How safe is INTELLiVENT -ASV?
Studie Automatische vs. Manuelle Einstellung Prospective randomized controlled study comparing conventional ventilation versus a fully closed-loop ventilation (IntelliVent ) in post cardiac surgery ICU patients Lellouche F, Bouchard PA, Wysocki M, Fiset J, Laubscher T, Novotni D, Lopez R, Brühschwein F, Durish G, L Her E Centre de recherche de l Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval, Québec, Canada Hamilton medical, Hôtel Dieu de Lévis, Québec, Canada, Methode: Heart Surgery - ICU INTELLiVENT -ASV SIMV PS Randomized 60 Patients SIMV / PS or automatic ventilation with INTELLiVENT ASV (> 4 Stunden) Lellouche F, Am J Respir Crit Care Med 181;2010:A6035
Methods Lellouche F, Am J Respir Crit Care Med 181;2010:A6035
Result VT and Pplat 12 VT (ml/kg PBW) 35 Pplat (cmh2o) 11 10 30 9 * * * * 25 8 7 20 6 5 Conventional (n = 30) IntelliVent (n = 30) 15 4 10 Randomisation 1h 2h 3h 4h Randomisation 1h 2h 3h 4h Lellouche F, Am J Respir Crit Care Med 181;2010:A6035
Result PEEP and FiO2 12 PEEP (cmh2o) 80 FiO2 (%) 9 70 60 6 50 3 Conventional (n = 30) IntelliVent (n = 30) 40 30 * * * * 0 20 Randomisation 1h 2h 3h 4h Randomisation 1h 2h 3h 4h Lellouche F, Am J Respir Crit Care Med 181;2010:A6035
Result: PaO2 and PaCO2 300 PaO2 (mmhg) 55 PaCO2 (mmhg) 250 200 150 100 * * * * 50 45 40 * 50 Conventional (n = 30) 35 0 IntelliVent (n = 30) 30 Randomisation 1h 2h 3h 4h Randomisation 1h 2h 3h 4h Lellouche F, Am J Respir Crit Care Med 181;2010:A6035
Ventilation Zones : Definition (All should be) (if only one) (if only one) 30 99 Lellouche F, Am J Respir Crit Care Med 181;2010:A6035
Result: Ventilation Zones % of the study duration 100 90 80 70 60 50 40 30 20 p < 0.01 p < 0.01 Conventional (n = 30) IntelliVent (n = 30) p = 0.12 p < 0.01 10 9 8 7 6 5 4 3 2 number 10 1 0 Optimal Acceptable Sub-optimal Manual adjustments/pt 0 Lellouche F, Am J Respir Crit Care Med 181;2010:A6035
Study Automatic vs. Manual Summary: INTELLiVENT was safer than manual settings 86% of the time in optimal Zone (vs. 6%) and only 3% of the time in suboptimal Ventilation Zone (vs. 21%) Automatic FiO2 weaning Automatic reduction of VT 8 ml/kg PKG Less users Adjustments Lellouche F, Am J Respir Crit Care Med 181;2010:A6035
Study Cross Over ASV vs. INTELLiVENT INTELLiVENT versus ASV in Medical ICU patients: Prospective cross over controlled study Arnal JM 1, Wysocki M 2, Demory D 1, Durisch G 2, Laubscher T 2, Novotni D 2, Lopez R 2, Brüschwein F 2, Durand-Gasselin J 1 Methode: Baseline ASV oder IntelliVent 120 min Wash out 30 min IntelliVent oder ASV 120 min ABG 19 Patienten with normal lung (12 coma: stroke, head trauma / 7 septic shock ) ABG 31 ALI/ARDS patients ( 20 pulmonary injury: CAP, aspiration, chest trauma, post surgery pneumonia / 11 extrapulmonary injury: septic shock, pancreatitis ) Arnal JM, Am J Respir Crit Care Med 181;2010:A3004
Ventilation delivered All patients (n= 50) ASV IntelliVent p Cstat (ml/cmh 2 0) 40 + 16 37 + 12 0,191 Rinsp (cmh 2 O/L/s) 17 + 4 17 + 5 0,970 RCexp 0,7 + 0,1 0,6 + 0,1 0,343 %MV (%) 128 + 27 114 + 29 0,003 V T /PBW (ml/kg) 8,4 + 0,8 8,1 + 0,8 0,003 RR (breath/min) 15 + 3 14 + 3 <0,001 Ppeak (cmh 2 0) 29 + 8 26 + 6 <0,001 Pplat (cmh 2 0) 24 + 6 22 + 6 0,016 PEEP (cmh 2 O) 10 + 4 9 + 5 0,015 FiO 2 (%) 45 + 18 37 + 13 <0,001 ph 7,30 + 0,08 7,28 + 0,10 0,078 PaO 2 (mmhg) 102 + 34 91 + 24 0,064 PaO 2 /FiO 2 (mmhg) 250 + 107 263 + 94 0,124 PaCO 2 (mmhg) 38 + 7 41 + 10 0,024 EtCO 2 (mmhg) 39 + 6 42 + 6 0,002 SaO 2 (%) 96 + 3 95 + 4 0,018 Arnal JM, Am J Respir Crit Care Med 181;2010:A3004
Better control of MV and EtCO2 ASV IntelliVent 18 16 Minute volume 35 30 EtCO 2 Number of patient 14 12 10 8 6 4 Number of patient 25 20 15 10 2 5 0 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Minute volume (L/min) 0 15 20 25 30 35 40 45 50 55 60 65 70 EtCO 2 Arnal JM, Am J Respir Crit Care Med 181;2010:A3004
Lower and better control of VT and Ppeak ASV IntelliVent 16 14 Tidal volume 10 Peak pressure 12 8 Number of patient 10 8 6 Number of patient 6 4 4 2 2 0 4,5 5,0 5,5 6,0 6,5 7,0 7,5 8,0 8,5 9,0 9,5 10,0 10,5 11,0 11,5 V T /PBW (ml/kg) 0 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 Peak pressure (cmh 2 O) Arnal JM, Am J Respir Crit Care Med 181;2010:A3004
Study Cross Over ASV vs. INTELLiVENT Zusammenfassung: INTELLiVENT is as safe as ASV in passive Patients INTELLiVENT is better than ASV in regards of VT and Pplat INTELLiVENT : lower MV lower FiO2 lower PEEP Achieves the same Oxygenation/Ventilation relation More efficient ventilation? More lung protection? Arnal JM, Am J Respir Crit Care Med 181;2010:A3004
COMPLETE Closed Loop Ventilation INTELLIVENT-ASV increaes safety reducing the potential for mistakes and errors reducing the risk of escalations applying lung protective rules INTELLIVENT-ASV reduces Stress for the entire staff Nuissance alarms are reduced by continuous adaption of ventilation to patient needs. Less alarms and ventilator adjustments during transient states of the patient Automatic adjustments of ventilator settings (like FiO2) before patient conditions deteriorates
Complete Closed loop ventilation INTELLIVENT-ASVreduces complexity giving guidance on complex decision making visualizing complex information in an intuitive way implementing and supporting protocolized care INTELLIVENT-ASV gives more time reducing the burden of routine tasks and adjustments reducing stress for the entire staff increasing the availability of staff bedside