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Noninvasive Ventilation
       in Pediatrics
   Ira M. Cheifetz, MD, FCCM, FAARC
           Professor of Pediatrics
        Chief, Pediatric Critical Care
Medical Director, PICU and Peds Resp Care
         Duke Children’s Hospital
                Children’s
NIV: Is it worth the effort?
♦ Noninvasive ventilation (NIV) is not a
  new concept.
♦ Many decades of experience
      acute hypoxic respiratory failure
  –
      post-extubation / facilitate extubation
  –
      neuromuscular weakness
  –
      upper & lower airway obstruction
  –

♦ So, why are some still unsure of using
 NIV for pediatric patients?
Available Data?
♦ Most data are from adults & neonates.
      very different populations
  –

♦ Most studies have involved patients with:
      acute hypercapneic respiratory failure
  –
      co-morbidities
       co-morbidities
  –
      ‘‘preemies’
        preemies’
  –

♦ Very few studies have evaluated NIV for
  ‘‘pure’ acute hypoxic resp failure.
    pure’
♦ No conclusive pediatric data – just one
  study.
38th Journal Conference:
  ‘Respiratory Controversies in the
        Critical Care Setting’
Should NIV be used for all forms of acute
          respiratory failure?
  Hess and Fessler, Resp Care, 2007
NIV is for all forms of ARF
♦   Tremendous clinical experience
    Utilization of NIV has ↑ dramatically
♦

♦   Significant recent technical advances
♦   7 systematic reviews published to date with
    consistent conclusions
        NIV ↓ intubation rate & mortality
    –
    –

♦   Clear data for adult patients
        COPD, card pulm edema, lung resection, solid
    –
    –
        organ transplantation / immunosuppressed patients,
        prevent extubation failure, asthma.

              Hess and Fessler, Resp Care, 2007
NIV is for all forms of ARF
♦   Hypoxemic respiratory failure
        ↓ intubation rate & mortality
    –
        (meta-analysis; Keenan, CCM, 2004)
        (meta-analysis;
♦   Nosocomial pneumonia
        ↓ risk of VAP with NIV
    –
        (meta-analysis; Hess, Respir Care, 2005)
        (meta-analysis;
♦   Common exclusions
        airway protection, unable to fit mask,
    –
        severe illness, uncooperative patient

             Hess and Fessler, Resp Care, 2007
NIV is NOT for all forms of ARF
    No Δ in reintubation rates, mortality, or benefit in
♦
    hypercarbic subset (Keenan, JAMA, 2002)
♦   NIV does not work to rescue patients with resp
    distress after extubation (Esteban, NEJM, 2004)
♦   Evidence of harm?
        resp failure after extubation → ↑ mortality
    –

♦   Should not be used in patients with a high
    likelihood of failure.
♦   NIV: ‘‘No clear advantage’
           No       advantage’
              Hess and Fessler, Resp Care, 2007
Should NIV be used for all forms of
       acute resp failure?
Excluding ICU bed availability and other
administrative and technical issues, how
many of the 13 experts routinely use NIV in
patients with ARF?

            Everyone


       Hess and Fessler, Resp Care, 2007
Now, let’s take a closer look
        at the data!
Non-invasive Ventilation
    ↓ intubation rate, ICU LOS, & ICU mortality
♦
        Keenan, CCM, 2004 (meta-analysis)
                          (meta-analysis)
    –
    –

    ↓ nosocomial pneumonia risk
♦
        Hess, Respir Care, 2005 (meta-analysis)
                                (meta-analysis)
    –
    –
NIV to Avoid Intubation
              90
                                                                 NPPV     Control
              80

              70

              60
% intubated




              50

              40

              30

              20

              10

              0
                    Brochard     Vitacca   Brochard   Kramer   Wysocki   Confalonieri
                      1990        1993       1995      1995     1995        1996



                               Marini, Crit Care Med, 2008
Antonelli, New Eng J Med, 1998.
Antonelli, New Eng J Med, 1998.
Hilbert, New Eng J Med, 2001.
Hilbert, New Eng J Med, 2001.
NIV     ‘standard’     p
               (n=114)     (n=107)
reintubation     48%        48%        n.s.
rate
time to         12 hrs     2.5 hrs     0.021
reintubation
mortality        25%        14%        0.048




        Esteban, New Eng J Med, 2004
Predictors?
               NIV failure    NIV success
                (n = 38)        (n = 16)     p
Age                64             60        0.86
APACHE III        81.5           55.5       <0.01
Sepsis             33             14         0.9
Shock              19             0           -
PaO2/FiO2         112            147        0.02
PaCO2              36             42         0.1
pH                7.37           7.39        0.4
Base excess       -4.0            0.5       0.01

              Rana, Crit Care, 2006
NIV and Asthma




 Soroksky, Chest, 2003
Hill, Crit Care Med, 2007
Pediatric Data
♦ Randomized, controlled trial

  – Yanez, Pediatr Crit Care Med, 2008

♦ What else has been published?

  – case series

  – case reports

  – poorly controlled studies

  – not even a well-performed survey study
Pediatric Data




Yanez, Pediatr Crit Care Med, 2008
Pediatric Data




Yanez, Pediatr Crit Care Med, 2008
Pediatric Data




Yanez, Pediatr Crit Care Med, 2008
Peds NIV
         Is it worth the effort?
♦ NIV in peds is increasing at an exponential
  rate despite the lack of convincing data.
♦ Why?

  – same reasons as for adult pts & neonates

  – avoid intubation

  – facilitate extubation

  – ↓ length of ventilation
Real Life Situation
♦ 7 month old infant (5.9 kg)

♦ Problem list: large VSD s/p repair,
  pulmonary hypertension (on sildenafil),
  chronic lung disease, upper airway
  obstruction, severe GE reflux….
♦ Mechanically ventilated for 8 weeks

♦ Now on minimal vent support & ‘stable’

♦ Ready for extubation trial??
NIV: Available Technology
♦   Neonatal CPAP
        stand alone systems
    –

        full-service ventilators
    –

♦   Bi-level ventilation (i.e., BiPAP)
        limited availability of FDA approved
    –
        equipment (ventilator and interface)
♦   Reintubation – not an ideal option
♦   A real dilemma for the clinician
Pediatric NIV
♦ Challenges – substantial

♦ Current technology – real limitations

♦ Opportunities – huge
Challenges:
         Patient Population
♦ Variability in patient size and age
  – neonates to 18 years
  – 3 kg to > 100 kg
♦ Variety of diagnosis (medial and surgical)
  – acute hypoxemic respiratory failure
  – neuromuscular weakness
  – cardiac
  – airway obstruction
Challenges: Technical
♦ Inspiratory flow
      ideally flow should be adjustable
  –

♦ Response time
      needs to be ‘fast’ and able to reliably
  –
      synchronize with the infant / child
♦ Monitoring (currently minimal)
      tidal volume
  –

      graphics
  –
      capnography
  –
Challenges: Interface
♦ Probably the biggest challenge

♦ Optimize patient comfort

♦ Must protect the skin and the eyes

  – an added challenge in the infant
    population (‘not much room to work’)
               (‘not              work’)
♦ Nasal vs. full face masks
Pediatric NIV
♦ Challenges – substantial

♦ Current technology – real limitations

♦ Opportunities – huge
Current Technology
♦ Why not just use adult technology for peds
  patients?
   – some do!

♦ Is this ideal?

  – no!
What are the problems?
♦ High inspiratory flow rates
      dried secretions → potential for airway
  –
      obstruction
      patient discomfort due to high flow rates
  –

♦ Interfaces – generally not designed for
 infants and small children
      comfort
  –

      skin integrity
  –
Nasal Mask
FULL Face Mask
Securing Devices
What are we often left with?
So, why try NIV?
♦ To avoid invasive mechanical ventilation
 and all of its associated complications.
  – increased pharmacologic sedation

  – secondary lung injury

  – airway injury

  – nosocomial pneumonia

  – and, others….
Pediatric NIV
♦ Challenges – substantial

♦ Current technology – real limitations

♦ Opportunities – huge
Potential Applications
♦   Hypoxemic respiratory failure / ALI
        pneumonia, aspiration, any etiology
    –

♦   Upper and lower airway obstruction
        subglottic stenosis; tracheolaryngomalacia
    –
        asthma; bronchiolitis
    –

♦   Neuromuscular weakness
        critical illness myopathy
    –
        spinal muscular atrophy
    –

♦   Application should be based on patho-
    physiology; not necessarily on diagnosis.
Potential Applications
♦ Special populations
    immunosuppressed patients;
  –
    s/p bone marrow transplantation
  – chronic lung disease;
    bronchopulmonary dysplasia
♦ Overall goals
    avoid intubation
  –
  – encourage prompt extubation
  – ↓ length of ventilation
How many patients?
♦ International data are difficult to estimate.
♦ Duke data – NIV for acute etiologies
  – PICU – 87 pts over 12 mos representing
    425 vent-days (average 4.9 days)
  – PBMT unit – 11 pts over 12 mos
    representing 141 vent-days (average
    12.8 days)
  – And, this is without ideal technology or
    equipment.
Technology: How small?
♦ Age limits?     ♦ Weight limits?

  – 5 years?        – 20 kg?

  – 1 year?         – 10 kg?

  – 1 month?        – 5 kg?

  – 1 week?         – 3 kg?

♦ The smaller, the better!
Pediatric NIV: Summary
♦   Technology (which is as good as the ‘adult’
    products) does not currently exist for infants
    and small children.
♦   Interfaces are probably the biggest challenge.
♦   Clinical need for technology does exist.
♦   Need more pediatric data, but the use of NIV
    in pediatrics seems reasonable based on
    extrapolation from the neonatal and adult
    populations.
♦   Need consistent guidelines / protocols.
Pediatric NIV: Summary
♦ Use of NIV in the pediatric population is
  growing at an increasing rate.
♦ Is it worth the effort?

  – yes

♦ Do the benefits outweigh the risks?

  – probably

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NIPV for Peds

  • 1. Noninvasive Ventilation in Pediatrics Ira M. Cheifetz, MD, FCCM, FAARC Professor of Pediatrics Chief, Pediatric Critical Care Medical Director, PICU and Peds Resp Care Duke Children’s Hospital Children’s
  • 2. NIV: Is it worth the effort? ♦ Noninvasive ventilation (NIV) is not a new concept. ♦ Many decades of experience acute hypoxic respiratory failure – post-extubation / facilitate extubation – neuromuscular weakness – upper & lower airway obstruction – ♦ So, why are some still unsure of using NIV for pediatric patients?
  • 3. Available Data? ♦ Most data are from adults & neonates. very different populations – ♦ Most studies have involved patients with: acute hypercapneic respiratory failure – co-morbidities co-morbidities – ‘‘preemies’ preemies’ – ♦ Very few studies have evaluated NIV for ‘‘pure’ acute hypoxic resp failure. pure’ ♦ No conclusive pediatric data – just one study.
  • 4. 38th Journal Conference: ‘Respiratory Controversies in the Critical Care Setting’ Should NIV be used for all forms of acute respiratory failure? Hess and Fessler, Resp Care, 2007
  • 5. NIV is for all forms of ARF ♦ Tremendous clinical experience Utilization of NIV has ↑ dramatically ♦ ♦ Significant recent technical advances ♦ 7 systematic reviews published to date with consistent conclusions NIV ↓ intubation rate & mortality – – ♦ Clear data for adult patients COPD, card pulm edema, lung resection, solid – – organ transplantation / immunosuppressed patients, prevent extubation failure, asthma. Hess and Fessler, Resp Care, 2007
  • 6. NIV is for all forms of ARF ♦ Hypoxemic respiratory failure ↓ intubation rate & mortality – (meta-analysis; Keenan, CCM, 2004) (meta-analysis; ♦ Nosocomial pneumonia ↓ risk of VAP with NIV – (meta-analysis; Hess, Respir Care, 2005) (meta-analysis; ♦ Common exclusions airway protection, unable to fit mask, – severe illness, uncooperative patient Hess and Fessler, Resp Care, 2007
  • 7. NIV is NOT for all forms of ARF No Δ in reintubation rates, mortality, or benefit in ♦ hypercarbic subset (Keenan, JAMA, 2002) ♦ NIV does not work to rescue patients with resp distress after extubation (Esteban, NEJM, 2004) ♦ Evidence of harm? resp failure after extubation → ↑ mortality – ♦ Should not be used in patients with a high likelihood of failure. ♦ NIV: ‘‘No clear advantage’ No advantage’ Hess and Fessler, Resp Care, 2007
  • 8. Should NIV be used for all forms of acute resp failure? Excluding ICU bed availability and other administrative and technical issues, how many of the 13 experts routinely use NIV in patients with ARF? Everyone Hess and Fessler, Resp Care, 2007
  • 9. Now, let’s take a closer look at the data!
  • 10. Non-invasive Ventilation ↓ intubation rate, ICU LOS, & ICU mortality ♦ Keenan, CCM, 2004 (meta-analysis) (meta-analysis) – – ↓ nosocomial pneumonia risk ♦ Hess, Respir Care, 2005 (meta-analysis) (meta-analysis) – –
  • 11. NIV to Avoid Intubation 90 NPPV Control 80 70 60 % intubated 50 40 30 20 10 0 Brochard Vitacca Brochard Kramer Wysocki Confalonieri 1990 1993 1995 1995 1995 1996 Marini, Crit Care Med, 2008
  • 12.
  • 13. Antonelli, New Eng J Med, 1998.
  • 14. Antonelli, New Eng J Med, 1998.
  • 15.
  • 16. Hilbert, New Eng J Med, 2001.
  • 17. Hilbert, New Eng J Med, 2001.
  • 18.
  • 19. NIV ‘standard’ p (n=114) (n=107) reintubation 48% 48% n.s. rate time to 12 hrs 2.5 hrs 0.021 reintubation mortality 25% 14% 0.048 Esteban, New Eng J Med, 2004
  • 20. Predictors? NIV failure NIV success (n = 38) (n = 16) p Age 64 60 0.86 APACHE III 81.5 55.5 <0.01 Sepsis 33 14 0.9 Shock 19 0 - PaO2/FiO2 112 147 0.02 PaCO2 36 42 0.1 pH 7.37 7.39 0.4 Base excess -4.0 0.5 0.01 Rana, Crit Care, 2006
  • 21. NIV and Asthma Soroksky, Chest, 2003
  • 22.
  • 23. Hill, Crit Care Med, 2007
  • 24. Pediatric Data ♦ Randomized, controlled trial – Yanez, Pediatr Crit Care Med, 2008 ♦ What else has been published? – case series – case reports – poorly controlled studies – not even a well-performed survey study
  • 25. Pediatric Data Yanez, Pediatr Crit Care Med, 2008
  • 26. Pediatric Data Yanez, Pediatr Crit Care Med, 2008
  • 27. Pediatric Data Yanez, Pediatr Crit Care Med, 2008
  • 28. Peds NIV Is it worth the effort? ♦ NIV in peds is increasing at an exponential rate despite the lack of convincing data. ♦ Why? – same reasons as for adult pts & neonates – avoid intubation – facilitate extubation – ↓ length of ventilation
  • 29. Real Life Situation ♦ 7 month old infant (5.9 kg) ♦ Problem list: large VSD s/p repair, pulmonary hypertension (on sildenafil), chronic lung disease, upper airway obstruction, severe GE reflux…. ♦ Mechanically ventilated for 8 weeks ♦ Now on minimal vent support & ‘stable’ ♦ Ready for extubation trial??
  • 30.
  • 31.
  • 32. NIV: Available Technology ♦ Neonatal CPAP stand alone systems – full-service ventilators – ♦ Bi-level ventilation (i.e., BiPAP) limited availability of FDA approved – equipment (ventilator and interface) ♦ Reintubation – not an ideal option ♦ A real dilemma for the clinician
  • 33.
  • 34.
  • 35. Pediatric NIV ♦ Challenges – substantial ♦ Current technology – real limitations ♦ Opportunities – huge
  • 36. Challenges: Patient Population ♦ Variability in patient size and age – neonates to 18 years – 3 kg to > 100 kg ♦ Variety of diagnosis (medial and surgical) – acute hypoxemic respiratory failure – neuromuscular weakness – cardiac – airway obstruction
  • 37. Challenges: Technical ♦ Inspiratory flow ideally flow should be adjustable – ♦ Response time needs to be ‘fast’ and able to reliably – synchronize with the infant / child ♦ Monitoring (currently minimal) tidal volume – graphics – capnography –
  • 38. Challenges: Interface ♦ Probably the biggest challenge ♦ Optimize patient comfort ♦ Must protect the skin and the eyes – an added challenge in the infant population (‘not much room to work’) (‘not work’) ♦ Nasal vs. full face masks
  • 39. Pediatric NIV ♦ Challenges – substantial ♦ Current technology – real limitations ♦ Opportunities – huge
  • 40. Current Technology ♦ Why not just use adult technology for peds patients? – some do! ♦ Is this ideal? – no!
  • 41. What are the problems? ♦ High inspiratory flow rates dried secretions → potential for airway – obstruction patient discomfort due to high flow rates – ♦ Interfaces – generally not designed for infants and small children comfort – skin integrity –
  • 45. What are we often left with?
  • 46. So, why try NIV? ♦ To avoid invasive mechanical ventilation and all of its associated complications. – increased pharmacologic sedation – secondary lung injury – airway injury – nosocomial pneumonia – and, others….
  • 47. Pediatric NIV ♦ Challenges – substantial ♦ Current technology – real limitations ♦ Opportunities – huge
  • 48. Potential Applications ♦ Hypoxemic respiratory failure / ALI pneumonia, aspiration, any etiology – ♦ Upper and lower airway obstruction subglottic stenosis; tracheolaryngomalacia – asthma; bronchiolitis – ♦ Neuromuscular weakness critical illness myopathy – spinal muscular atrophy – ♦ Application should be based on patho- physiology; not necessarily on diagnosis.
  • 49. Potential Applications ♦ Special populations immunosuppressed patients; – s/p bone marrow transplantation – chronic lung disease; bronchopulmonary dysplasia ♦ Overall goals avoid intubation – – encourage prompt extubation – ↓ length of ventilation
  • 50. How many patients? ♦ International data are difficult to estimate. ♦ Duke data – NIV for acute etiologies – PICU – 87 pts over 12 mos representing 425 vent-days (average 4.9 days) – PBMT unit – 11 pts over 12 mos representing 141 vent-days (average 12.8 days) – And, this is without ideal technology or equipment.
  • 51. Technology: How small? ♦ Age limits? ♦ Weight limits? – 5 years? – 20 kg? – 1 year? – 10 kg? – 1 month? – 5 kg? – 1 week? – 3 kg? ♦ The smaller, the better!
  • 52. Pediatric NIV: Summary ♦ Technology (which is as good as the ‘adult’ products) does not currently exist for infants and small children. ♦ Interfaces are probably the biggest challenge. ♦ Clinical need for technology does exist. ♦ Need more pediatric data, but the use of NIV in pediatrics seems reasonable based on extrapolation from the neonatal and adult populations. ♦ Need consistent guidelines / protocols.
  • 53. Pediatric NIV: Summary ♦ Use of NIV in the pediatric population is growing at an increasing rate. ♦ Is it worth the effort? – yes ♦ Do the benefits outweigh the risks? – probably