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AUTOMATED MODES OF VENTILATION: SUPERIOR TO TRADITIONNAL MODES ?

AUTOMATED MODES OF VENTILATION: SUPERIOR TO TRADITIONNAL MODES ?. François LELLOUCHE, MD, PhD. CONFLICTS OF INTEREST. - Research contracts with Drager medical (travel expenses for the Canadian study on SmartCare) - Research contracts with Hamilton medical to conduct Intellivent evaluation

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AUTOMATED MODES OF VENTILATION: SUPERIOR TO TRADITIONNAL MODES ?

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  1. AUTOMATED MODES OF VENTILATION: SUPERIOR TO TRADITIONNAL MODES ? François LELLOUCHE, MD, PhD

  2. CONFLICTS OF INTEREST - Research contracts with Drager medical (travel expenses for the Canadian study on SmartCare) - Research contracts with Hamilton medical to conduct Intellivent evaluation (Salary of the research assistant) - Program of research on automated ventilation and oxygen therapy: Canadian for Innovation(Fonds des Leaders)/FRSQ grants - President of a R&D compagny that develops automated systems for oxygen therapy and mechanical ventilation

  3. PLAN Why automated modes are required ? SmartCare: automated adjustment of pressure support, automated weaning Intellivent: automated mechanical ventilation Clinical evaluation SmartCare Intellivent Conclusion: even equivalent would be worth…..

  4. PLAN Why automated modes are required ? SmartCare: automatedadjustment of pressure support, automatedweaning Intellivent: automatedmechanical ventilation Clinicalevaluation SmartCare Intellivent Conclusion: evenequivalentwouldbeworth…..

  5. Whyautomated modes are required ? Age pyramid US: 1950-2050 ♂ ♀ …. To the first baby-boomers !! Millions of people

  6. Age Pyramid Comorbidities patients on MV Number of clinicians Angus JAMA 2000

  7. Needham CCM 2005

  8. Data for USA Increasing number of patients with prolonged MV (> 96 hours) Cost of MV : 16 billions of $/per year in 2003  60 billions of $/per year in 2020 (projection) Zilberberg, CCM 2008

  9. Why automated modes are required ? Failure of the knowledge transfert Weaning/protective ventilatory strategy Rubbenfeld Respiratory Care 2004 Vilar Acta Anesthesiol Scand 2004 Scale Crit Care Med 2008

  10. ARMA Study 6 vs 12 ml/Kg of PBW …. To the first baby-boomers !! FAILURE TO IMPLEMENT KNOWLEDGE CHALLENGES FOR HEALTH CARE SYSTEM AUTOMATED SYSTEMS

  11. COMMERCIALLY AVAILABLE AUTOMATED MODES

  12. PLAN Whyautomated modes are required ? SmartCare: automated adjustment of pressure support, automated weaning Intellivent: automatedmechanical ventilation Clinicalevaluation SmartCare Intellivent Conclusion: evenequivalentwouldbeworth…..

  13. Rationale for weaning automation Weaning protocols are efficient (Ely NEJM 1996, Saura ICM 1996, Kollef CCM 1997, Marelich 2000) Weaning protocols are recommended (Mc Intyre Chest 2001, Boles ERJ 2007) …..but many obstacles (Ely AJRCCM 1999, Vitacca ICM 2001) to implement weaning protocols trainings on a regular basis required, problems with new protocols and new practices acceptance…

  14. Automated Weaning: SmartCare • 1) Automated adaptation of PSV level • 2) Automated weaning protocol • automatic decrease of the PSV • automatic SBT Ventilator in PSV Ventilator Ventilator in PSV Patient Monitor Patient Monitor Alarms Alarms Control Control Automated pressure support Automated Weaning Patient Patient Automatic SmartCare Weaning RR, TV, EtCO RR, TV, EtCO System 2 Output Processing Input

  15. Automated Weaning : SmartCare • Pressure support ventilation • Automated adaptation of the PS level • Comfort Zone : 15 < RR < 30 breath/min • Tidal Vol > min level, ETCO2 < safety limit • Automated weaning strategy • Progressive decrease of the PS level • Spontaneous breathing test before extubation • Recommendation for extubation PEEP and FiO2 are not managed by the system Dojat et al. Int J Clin Monit Comput 1992

  16. Example of Weaningwith«SmartCare » Automated reduction of the PSV level Message: « separation from ventilator » EXTUBATION Minimum level of PS PEEP must be  5 cmH2O « Automated SBT »

  17. PLAN Whyautomated modes are required ? SmartCare: automatedadjustment of pressure support, automatedweaning Intellivent: automated mechanical ventilation Clinicalevaluation SmartCare Intellivent Conclusion: evenequivalentwouldbeworth…..

  18. Intellivent stems from ASV • ASV = Pressure controlled and Pressure assisted mode • Automatic transition from controlled to assisted ventilation • Automatic adjustement of RR (Ti/Te) and TV (Pressure, cycling off) for • Constant minute ventilation  SET BY THE CLINICIAN WITH ASV • Minimized work of breathing (based on patient’s respiratory mechanics: time constant and resistance continuously evaluated) • Minimized intrinsic PEEP • Based on physiologic Otis and Meade equations • With ASV NO ADJUSTMENT OF PEEP AND FiO2 INTELLIVENT

  19. Mead, JAP 1960 Otis, JAP 1950

  20. Automated Ventilation : Intellivent • 1) Ventilation controller: Automated adaptation of minute ventilation (RR, TV) / EtCO2 • 2) Oxygenation controller: Automated adaptation of PEEP and FiO2 / SpO2 Ventilator Patient Monitor Patient Monitor Alarms Alarms Control Control Automated Ventilation (RR,TV) Automated Oxygenation (PEEP/FiO2) Patient Patient Automatic Output Intellivent Weaning RR, TV, EtCO System 2 Processing Input SpO2, Heart Lung Index

  21. PEEP limitation - Heart-Lung Index (HLI) HEART vs LUNG: not OK HEART vs LUNG: OK Pulse oxymeter Plethysmogram (mm) Delta PP Arterial Pressure (mmHg) Delta POP Airway Pressure (cmH2O)

  22. Still 3 knobs… Adaptive Support Ventilation

  23. Intellivent: the NO knobs concept… FULLY AUTOMATIC

  24. Intellivent = fully automatic Gender, patient height  estimation of the target minute ventilation Clinical situations  modifies the target for the controllers Press Start ! Ventilation controller ASV EtCO2 Oxygenation controller SpO2

  25. PLAN Whyautomated modes are required ? SmartCare: automatedadjustment of pressure support, automatedweaning Intellivent: automatedmechanical ventilation Clinical evaluation SmartCare Intellivent Conclusion: evenequivalentwouldbeworth…..

  26. INITIAL CLINICAL EVALUATIONS OF SMARTCARE (prototype = NéoGanesh) Dojat et al. AJRCCM 1992 Maintain of the patients in the comfort zone 95% of time 19 patients Dojat et al. AJRCCM 1996 Good performances of the system to predictextubationsuccess/failures 38 patients Dojat et al. AJRCCM 2000 Efficiency of the system to maintain the patient in a comfortzone Reduction of time withhigh P0.1 56 modifications of PSV/24 hrs vs 1 modification PSV/24 hrs 10 patients Bouadma, Lellouche et al. Intensive Care Med 2005 Possibility to ventilate patients with the system duringprolongedperiods (up to 12 days)-Pilot study for multicenter RCT 42 patients

  27. 1st Multicenter Randomized Study Objective of the study VS Usual protocolized weaning Automated weaning Primary end point: Weaning time (inclusion  first extubation)

  28. Lellouche et al, AJRCCM 2006,174:894-900

  29. WEAN pilot study Co-PI: K.Burns/F.Lellouche RCT PILOT/ FEASABILITY SmartCare vs written weaning protocols 8 Centers Primary outcomeacceptance of weaning protocols

  30. OUTCOME DATA Feasibility for a larger RCT ?......

  31. Automated weaning (SmartCare) vs local weaning protocols in post-surgical patients Randomized Controlled Trial Post-op patients with MV > 9 hours 300 patients included 94±144 hours (SmartCare) 118±165 hours (Protocols) (P=0.12)

  32. Randomized Controlled Trial Medical patients 102 patients included Rose Intensive Care Medicine 2008

  33. Schadler, ATS 2009 Lellouche, AJRCCM 2006 In the context of increasing gap betweenneeds and supply to manage patients on MV, bothstudies are positive : Better (or sameoutcome) withlesshuman interventions

  34. EVALUATION OF INTELLIVENT = FULLY AUTOMATIC MECHANICAL VENTILATION • Feasibility study • Does the system can safely manage stable patients after cardiac surgery ? • Does the system reduce the workload ? • Context: recent data (from cardiac surgery database) showing the need to reduce tidal volume after cardiac surgery (prophylactic protective ventilation…)

  35. Impact of tidal volumes even in patients with normal lungs 3434 patients after CABG or valve surgery Multivariateanalysis  High tidal volumes aftercardiacsurgery are independantriskfactors for - organdysfunction - ICU Length of stay Non parametric logistic regression Lellouche et al ATS 2010

  36. Cardiacsurgery= interesting to evaluate a fullyautomated system • Dynamicclinical condition • Within 2-4 hours • Temperature 35˚C  37˚C (↗CO2 production) • FiO2 70  40-30% • Controlled assisted ventilation • Workloadrelated to mechanical ventilation settings: • Adjustment of minute-ventilation • PEEP/FiO2weaning • Switch to PSV

  37. Study design Randomization ICU admission Intellivent group Automated ventilation Modified G5 Consent 15 minutes Criteria for Consent SURGERY Inclusion criteria + Exclusion criteria - 4 hours Connection to a G5 ventilator Settings by the anesthesiologist Control group Protocolized Ventilation G5 : SIMV+PSV Inclusion Criteria - Hemodynamic stability 1. < 3 red-cell Tf units within last 15 min 2. Epi or norepinephrine below < 1 mg/h 3. Bleeding <100 ml within last 15 min - No anuria Data from the ventilator recorded Timing of the interventions Time with optimal/non optimal ventilation Exclusion Criteria • Unexpected surgical procedure • Major complication during surgery • Early extubation expected (< 1 hour) • - Broncho-pleural fistula • - Study ventilator not available

  38. RESULTS • 90 consent signed • Delayed surgery (morning to afternoon cases) • Surgery postponed (emergent cases) • Hemodynamic instability at ICU arrival •  60 patients included from 07/2009 to 12/2009 • . ALL THE PATIENTS COMPLETED THE STUDY • . 1 patient needed re-operation for massive bleeding 1 hour after the randomization (Intellivent group). • . Duration of the study (min): • Control group Intellivent group P value • 194 + 43207 + 470.24

  39. RESULTS: MAIN OUTCOME % n 148 Control arm Intellivent arm * * 5 Control arm Intellivent arm Number of manual settings Optimal ventilation (TV < 10ml/Kg of PBW, Pressure < 30, SpO2, EtCO2)

  40. PLAN Whyautomated modes are required ? SmartCare: automatedadjustment of pressure support, automatedweaning Intellivent: automatedmechanical ventilation Clinicalevaluation SmartCare Intellivent Conclusion: even equivalent would be worth…..

  41. Computers in ICU: panacea or plague ? East TD, Respiratory Care 1992

  42. AUTOMATED MODES OF VENTILATION: SUPERIOR TO TRADITIONNAL MODES ? Conclusion: Even results equivalent to traditionnal modes would be worth….. in the demographic context Several studies demonstrate positive results to reduce the duration of mechanical ventilation and potential for workload reduction With…first generation systems More evaluation required (Intellivent …) Room for improvement in the next years AUTOMATED MODES OF VENTILATION: SUPERIOR TO HUMAN SETTINGS ?

  43. We should accept that automated systems could be superior to humans for specific tasks…

  44. THANKS ! PA Bouchard C Bouchard MC Ferland P Dubé ….

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