AUTOMATED MODES OF VENTILATION: SUPERIOR TO TRADITIONNAL MODES ?

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AUTOMATED MODES OF VENTILATION SUPERIOR TO
TRADITIONNAL MODES ?
François LELLOUCHE, MD, PhD
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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 RD compagny that
develops automated systems for oxygen therapy
and mechanical ventilation
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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..
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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..
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Why automated modes are required ?
Age pyramid US 1950-2050
?
?
Millions of people
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Age Pyramid Comorbidities
patients on MV
Number of clinicians
Angus JAMA 2000
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Needham CCM 2005
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Data for USA
Increasing number of patients with prolonged MV
(gt 96 hours)
Cost of MV 16 billions of /per year in 2003
? 60 billions of /per year in 2020 (projection)
Zilberberg, CCM 2008
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Why automated modes are required ?
Failure of the knowledge transfert Weaning/protect
ive ventilatory strategy
Rubbenfeld Respiratory Care 2004
Vilar Acta Anesthesiol Scand 2004
Scale Crit Care Med 2008
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COMMERCIALLY AVAILABLE AUTOMATED MODES

Mandatory Minute Ventilation Evita (Dräger) Hewlett Anesthesia 1977
Automode Servo (Maquet) Holdt Resp Care 2001
ASV G5 (Hamilton) Laubscher IEEE Biomed Eng 1994

SmartCare Evita XL, V500 (Dräger) Dojat Int J Clin Monit 1992
ASV ? Intellivent G5 (Hamilton) Brunner 2002
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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..
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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
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Automated Weaning SmartCare

• Pressure support ventilation
• Automated adaptation of the PS level
• Comfort Zone 15 lt RR lt 30 breath/min
• Tidal Vol gt min level, ETCO2 lt 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
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Example of Weaning with SmartCare
Automated reduction of the PSV level
Message separation from ventilator
EXTUBATION
Minimum level of PS
PEEP must be ? 5 cmH2O
Automated SBT
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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..
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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 patients
  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

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Mead, JAP 1960
Otis, JAP 1950
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SpO2, Heart Lung Index
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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)
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Adaptive Support Ventilation
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Intellivent the NO knobs concept
FULLY AUTOMATIC
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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
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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..
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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 predict extubation
success/failures 38 patients
Dojat et al. AJRCCM 2000 Efficiency of the system
to maintain the patient in a comfort
zone Reduction of time with high 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 during prolonged periods (up to 12
days)-Pilot study for multicenter RCT 42
patients
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1st Multicenter Randomized Study Objective
of the study
VS
Usual protocolized weaning
Automated weaning
Primary end point Weaning time (inclusion ?
first extubation)
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Lellouche et al, AJRCCM 2006,174894-900
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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
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OUTCOME DATA
Variables Protocol Weaning (n43) Automated Weaning (n51) p-value
Time to first extubation, days median (25-75) 4 (2-12) 3 (2-5) 0.02
Time to first successful extubation, days median (25-75) 5 (3-19) 4 (2-7) 0.10
Reintubation, n () 11 (25.5) 9 (17.7) 0.35
Patients with prolonged ventilation (gt21 days), n () 6 (18.2) 0 0.01
Ever had tracheostomy, n () 15 (34.9) 8 (16) 0.04
Total duration of intubation, days median (25-75) 10.5 (8, 17.5) 12 (6, 25) 0.37
Duration of ICU stay, days median (25-75) 9 (5, 25) 7 (5, 14) 0.13
Duration of Hospitalization, days median (25-75) 31.5 (16. 49.5) 22 (14, 33) 0.19
ICU death, n () 9 (20.9) 9 (17.7) 0.69
Feasibility for a larger RCT ?......
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Automated weaning (SmartCare) vs local weaning
protocols in post-surgical patients
Randomized Controlled Trial Post-op patients with
MV gt 9 hours 300 patients included
94144 hours (SmartCare) 118165 hours
(Protocols) (P0.12)
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Randomized Controlled Trial Medical patients 102
patients included
Rose Intensive Care Medicine 2008
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Schadler, ATS 2009
Lellouche, AJRCCM 2006
In the context of increasing gap between needs
and supply to manage patients on MV, both
studies are positive Better (or same outcome)
with less human interventions
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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)

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Impact of tidal volumes even in patients with
normal lungs
3434 patients after CABG or valve
surgery Multivariate analysis ? High tidal
volumes after cardiac surgery are independant
risk factors for - organ dysfunction - ICU
Length of stay
Non parametric logistic regression
Lellouche et al ATS 2010
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Cardiac surgery interesting to evaluate a fully
automated system

• Dynamic clinical condition
• Within 2-4 hours
• Temperature 35C ? 37C (?CO2 production)
• FiO2 70 ? 40-30
• Controlled ? assisted ventilation
• Workload related to mechanical ventilation
  settings
• Adjustment of minute-ventilation
• PEEP/FiO2 weaning
• Switch to PSV

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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
SIMVPSV
Data from the ventilator recorded Timing of the
interventions Time with optimal/non optimal
ventilation
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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 43 207 47
  0.24

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RESULTS MAIN OUTCOME

n
148
Control arm
Intellivent arm


5
Control arm
Intellivent arm
Number of manual settings
Optimal ventilation (TV lt 10ml/Kg of PBW,
Pressure lt 30, SpO2, EtCO2)
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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..
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Computers in ICU panacea or plague ?

• East TD, Respiratory Care 1992

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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 Withfirst generation systems More
evaluation required (Intellivent ) Room for
improvement in the next years
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THANKS !
PA Bouchard C Bouchard MC Ferland P Dubé .