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

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

(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

Why automated modes are required ?

SmartCare: automated adjustment of pressure support, automated weaning

Intellivent: automated mechanical ventilation

Clinical evaluationSmartCareIntellivent

Conclusion: even equivalent would be worth…..

PLAN






PLAN

Age pyramid US: 1950-2050

Millions of people

♀♂


…. To the firstbaby-boomers !!

Angus JAMA 2000

patients on MV

Number of clinicians

Age PyramidComorbidities

Needham CCM 2005

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

0

100 000

200 000

300 000

400 000

500 000

600 000

700 000

n pa

tien

ts

2000 2020

0

2

4

6

8

10

12

14

16

18

Days of MV * I CU LOS * Hospital LOS *

Mill

ions

of

days

2000 2020

Prolongedmechanical ventilat ion

252.577

605.898

1.5

3.8

2.3

5.86.6

16.7

Data for USA

Failure of the knowledge transfertWeaning/protective ventilatory strategy

Rubbenfeld Respiratory Care 2004

Vilar Acta Anesthesiol Scand 2004

Scale Crit Care Med 2008


…. To the firstbaby-boomers !!

ARMA Study6 vs 12 ml/Kg of PBW

FAILURE TO IMPLEMENT KNOWLEDGE

CHALLENGES FOR HEALTH CARE SYSTEM

AUTOMATED SYSTEMS

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

COMMERCIALLY AVAILABLE AUTOMATED MODES






PLAN

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…

Rationale for weaning automation

Control

Patient Monitor Alarms

Ventilator

Control


Ventilator in PSV

PatientPatient

Automated Weaning: SmartCare1) Automated adaptation of PSV level

2) Automated weaning protocol – automatic decrease of the PSV– automatic SBT

Ventilator in PSV

RR, TV, EtCORR, TV, EtCO2Input

Automated pressure support

Automated WeaningOutputAutomaticWeaningSystem

SmartCareProcessing

• Pressure support ventilationPressure support ventilation• Automated adaptation of the PS levelAutomated adaptation of the PS level

Comfort Zone : 15 < RR < 30 breath/minComfort Zone : 15 < RR < 30 breath/min

Tidal Vol > min level, ETidal Vol > min level, ETTCOCO22 < safety limit < safety limit

• Automated weaning strategyAutomated weaning strategy Progressive decrease of the PS levelProgressive decrease of the PS level Spontaneous breathing test before extubationSpontaneous breathing test before extubation Recommendation for extubationRecommendation for extubation

Dojat et al. Int J Clin Monit Comput 1992Dojat et al. Int J Clin Monit Comput 1992

PEEP and FiOPEEP and FiO22 are not managed by the system are not managed by the system

Automated Weaning : SmartCare

0

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16

18

0:00 0:28 0:57 1:26 1:55 2:24 2:52

Time (h:min)

Level o

f P

ressu

re s

up

po

rt (

cm

H 2

O)

Observation MaintainAdaptation

Minimum level of PS

« Automated SBT »

EXTUBATION

Automated reduction of the

PSV level

Message: « separation from ventilator »

PEEP must be 5 cmH2O

Example of Weaning with «SmartCare »Example of Weaning with «SmartCare »






PLAN

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

Otis, JAP 1950Mead, JAP 1960

Control


Ventilator

Control


PatientPatient

Automated Ventilation : Intellivent1) Ventilation controller: Automated adaptation of minute ventilation (RR, TV) / EtCO2

2) Oxygenation controller: Automated adaptation of PEEP and FiO2 / SpO2

RR, TV, EtCO2Input

Automated Ventilation (RR,TV)

Automated Oxygenation (PEEP/FiO2)

Output

AutomaticWeaningSystem

IntelliventProcessing

SpO2, Heart Lung Index

PEEP limitation - Heart-Lung Index (HLI)

HEART vs LUNG: not OK HEART vs LUNG: OK

Pulse oxymeterPlethysmogram

(mm)

Arterial Pressure(mmHg)

Airway Pressure(cmH2O)

Delta PP

Delta POP

Adaptive Support Ventilation

Still 3 knobs…

Intellivent: the NO knobs concept…

FULLY AUTOMATIC

Intellivent = fully automaticGender, patient height

estimation of the target minute ventilation

Clinical situations modifies the target for the controllers

Press Start !

Ventilation controller

ASV

Oxygenation controller

EtCO2

SpO2






PLAN

Dojat et al. AJRCCM 1996Dojat et al. AJRCCM 1996 Good performances of the system to predict extubation success/failuresGood performances of the system to predict extubation success/failures38 patients38 patients

Dojat et al. AJRCCM 2000Dojat et al. AJRCCM 2000Efficiency of the system to maintain the patient in a comfort zoneEfficiency of the system to maintain the patient in a comfort zoneReduction of time with high PReduction of time with high P0.10.1

56 modifications of PSV/24 hrs vs 1 modification PSV/24 hrs56 modifications of PSV/24 hrs vs 1 modification PSV/24 hrs10 patients10 patients

Dojat et al. AJRCCM 1992Dojat et al. AJRCCM 1992Maintain of the patients in the comfort zone 95% of timeMaintain of the patients in the comfort zone 95% of time19 patients 19 patients

INITIAL CLINICAL EVALUATIONS OF SMARTCARE(prototype = NéoGanesh)

Bouadma, Lellouche et al. Intensive Care Med 2005Bouadma, Lellouche et al. Intensive Care Med 2005Possibility to ventilate patients with the system during prolonged periods (up to Possibility to ventilate patients with the system during prolonged periods (up to 12 days)-Pilot study for multicenter RCT12 days)-Pilot study for multicenter RCT42 patients42 patients

YES

NO

YES NO

YES

EXTUBATI ON

NO

YES

YES

NO

Mechanical ventilationQuestion at least 2 times a day:

Weaning possible ?

Initiation of weaning• Stop or lowering of sedation• Level of Pressure Support : 20 cmH2O

Question at least 2 times a day: Spontaneous breathing test feasible ?

PS level 20 cmH2O above PEEP > 60 minutes ?

NO

Patient weaned but extubation not possible

- Level of consciousness OK- Efficient swallowing- Efficient cough

Extubation possible ?

Spontaneous breathing test during 30'First choice: Pressure support 10 cmH2O, ± PEEP 5 cmH2OOther choices: - T-piece trial- CPAP, flow 30 l/min. PEEP 5 cmH2O

Extubation criteria present ?

Extubation criteria (all must be present)- Respiratory rate 30/'- Pulse < 120/'- Syst. ABP < 180 and > 90 mmHg- No hemodynamic instability- PaO2 8.5 kPa and FIO2 0.40- pH > 7.30

Adaptation of PS and/or

PEEP level

Spontaneous breathing test feasible if after 60' withPS 20 cmH2O, PEEP 5 cmH2O (all must be

present):- Respiratory rate 30/'- Tidal volume 6 ml/kg- No hemodynamic instability- SpO2 90% and FIO2 0.40- No other contra-indication

Weaning possible if all following criteria are present:- Improvement of condition having led to intubation - Absence of uncontrolled severe infection- Correction of metabolic disorders- Adequate hemoglobin level - No hemodynamic instability- PaO2 > 8.5 kPa with FIO2 0.40 and PEEP 5 cmH2O

YES

NO

YES NO

YES

EXTUBATI ON

NO

YES

YES

NO

Mechanical ventilationQuestion at least 2 times a day:

Weaning possible ?

Initiation of weaning• Stop or lowering of sedation• Level of Pressure Support : 20 cmH2O

Question at least 2 times a day: Spontaneous breathing test feasible ?

PS level 20 cmH2O above PEEP > 60 minutes ?

NO

Patient weaned but extubation not possible

- Level of consciousness OK- Efficient swallowing- Efficient cough

Extubation possible ?

Spontaneous breathing test during 30'First choice: Pressure support 10 cmH2O, ± PEEP 5 cmH2OOther choices: - T-piece trial- CPAP, flow 30 l/min. PEEP 5 cmH2O

Extubation criteria present ?

Extubation criteria (all must be present)- Respiratory rate 30/'- Pulse < 120/'- Syst. ABP < 180 and > 90 mmHg- No hemodynamic instability- PaO2 8.5 kPa and FIO2 0.40- pH > 7.30

Adaptation of PS and/or

PEEP level

Spontaneous breathing test feasible if after 60' withPS 20 cmH2O, PEEP 5 cmH2O (all must be

present):- Respiratory rate 30/'- Tidal volume 6 ml/kg- No hemodynamic instability- SpO2 90% and FIO2 0.40- No other contra-indication

Weaning possible if all following criteria are present:- Improvement of condition having led to intubation - Absence of uncontrolled severe infection- Correction of metabolic disorders- Adequate hemoglobin level - No hemodynamic instability- PaO2 > 8.5 kPa with FIO2 0.40 and PEEP 5 cmH2O

Weaning process can begin if:

The cause of the respiratory failure is partially or completely controlled, including a

SpO2 90% under FIO2 0.5 and PEEP 5 cm H2O

Hemodynamic stability (Systolic Blood Pressure between 90 and 160mm Hg + Pulse

between 60 and 125 /minute + absence of uncontrolled arrhythmias)

Temperature < 39°C

Haemoglobin 8 g/dL

Absence of significant hydro-electrolytes abnormalities

Patients can follow simples orders and there is not need for high dose of sedatives

For neurological patients:

Glascow Coma Scale > 8, Intra-Cranial Pressure < 20 mmHg, Cerebral Perfusion

Pressure > 60 mmHg

Those patients who accomplish these criteria will follow a spontaneous breathing test (2 hours

T tube or Pressure Support Ventilation with 7 cm H2O of pressure support and Positive End

Expiratory Pressure 5 cm H2O). No tolerance to spontaneous breathing test will be

considerer if:

Respiratory Rate > 35 bpm + clinical manifestation *

Hypoxemia (PaO2 < 60 mmHg under O2 flow 4 L/min)

Acidosis (pH 7.3)

* Clinical manifestations: Systolic Blood Pressure 160 mmHg or 90 mmHg, Heart Rate

140 bpm or augmentation of 25% of baseline, new arrhythmia, lower conscience level,

sweating or agitation.

1. Patients will be extubated if they successfully complete the 2 hours spontaneous

breathing trial and they have an adequate cough

2. For patients that do not tolerate the spontaneous breathing test, weaning will continue

on Pressure Support Ventilation. Pressure Support will be adjusted to achieve a

respiratory frequency of 25-30 bpm and a good clinical adaptation. Pressure Support

will be diminished as soon as possible following patient’s clinical tolerance. Patients

will be extubated if tolerating low Pressure Support levels (next to 10 cm H2O) with

low PEEP levels ( 5 cm H2O) if clinical tolerance and cough are adequate.

1st Multicenter Randomized Study Objective of the study

Automated weaning Usual protocolized weaningVS

Primary end point:

Weaning time (inclusion first extubation)

Primary end point:

Weaning time (inclusion first extubation)

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

WEAN pilot studyCo-PI: K.Burns/F.Lellouche

RCTPILOT/ FEASABILITYSmartCare vs written weaning protocols8 CentersPrimary outcomeacceptance of weaning protocols

OUTCOME DATA

Variables Protocol Weaning (n=43)

Automated Weaning

(n=51)

p-value

Time to first extubation, days median (25-75) 4 (2-12) 3 (2-5) 0.02Time to first successful extubation, days median (25-75) 5 (3-19) 4 (2-7) 0.10Reintubation, n (%) 11 (25.5%) 9 (17.7%) 0.35Patients with prolonged ventilation (>21 days), n (%) 6 (18.2%) 0 0.01Ever had tracheostomy, n (%) 15 (34.9%) 8 (16%) 0.04Total duration of intubation, days median (25-75) 10.5 (8, 17.5) 12 (6, 25) 0.37Duration of ICU stay, days median (25-75) 9 (5, 25) 7 (5, 14) 0.13Duration of Hospitalization, days median (25-75) 31.5 (16. 49.5) 22 (14, 33) 0.19ICU death, n (%) 9 (20.9%) 9 (17.7%) 0.69

Feasibility for a larger RCT ?......

Automated weaning (SmartCare) vs local weaning protocols in post-surgical patients

Randomized Controlled TrialPost-op patients with MV > 9 hours300 patients included

94±144 hours (SmartCare)118±165 hours (Protocols)

(P=0.12)

Rose Intensive Care Medicine 2008

Randomized Controlled TrialMedical patients102 patients included

Schadler, ATS 2009Lellouche, 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

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…)

Non parametric logistic regression

Impact of tidal volumes even in patients with normal lungs

3434 patients after CABG or valve surgeryMultivariate analysis High tidal volumes after cardiac surgery are independant risk factors for

- organ dysfunction- ICU Length of stay

Lellouche et al ATS 2010

Cardiac surgery= interesting to evaluate a fully automated system

• Dynamic clinical condition• Within 2-4 hours

– Temperature 35˚C 37˚C (↗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

Criteria for Consent SURGERY Inclusion criteria +

Exclusion criteria -

Consent ICU admission

Connection to a G5 ventilator

Settings by the anesthesiologist

15 minutes

Intellivent groupAutomated ventilation

Modified G5

Control group Protocolized Ventilation

G5 : SIMV+PSV

Randomization

4 hours

- 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

- Unexpected surgical procedure- Major complication during surgery- Early extubation expected (< 1 hour)- Broncho-pleural fistula- Study ventilator not available

Inclusion Criteria

Exclusion Criteria

Study design

Data from the ventilator recordedTiming of the interventionsTime with optimal/non optimal ventilation

RESULTS

- 90 consent signedDelayed 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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15T

idal

Vo

lum

e (

ml/

Kg

PB

W)

Conventionnal

Intellivent

H0 H1 H2 H3 H4

* * *

RESULTS: MAIN OUTCOME

% n

Number of manual settings

148

5

Control arm

Intellivent arm

Control arm

Intellivent arm

Optimal ventilation (TV < 10ml/Kg of PBW, Pressure < 30, SpO2, EtCO2)

**






PLAN

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

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 TRADITIONNAL MODES ?

AUTOMATED MODES OF VENTILATION: SUPERIOR TO HUMAN SETTINGS ?

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

THANKS !

PA BouchardC BouchardMC FerlandP Dubé….

http://www.innovation.ca/

http://www.frsq.gouv.qc.ca/fr/index.shtml

Documents

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