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Introduction
The therapy and
Optiflow Junior
APPENDIX
The therapy and
Optiflow Junior
(CO N C I S E )
Clinical
Definition
What it is
Mechanisms
How it works
Physiological
outcomes
What it does
Clinical outcomes
What it means
Tools
Usage
Pressure
Economics
Optiflow Junior
The R&D journey
Optiflow Junior
Unique features
Videos
Introduction
Overview
Avoid intubation
NEONATAL
Readmission
ACUITY
LENGTH OF STAY
Shorten length-of-stay
(to free up beds)
PEDIATRIC
Readmission
ACUITY
Control costs
Avoid readmission
LENGTH OF STAY
A therapy arrives...
THE RESPIRATORY CARE CONTINUUM
INVASIVE
VENTILATION
nCPAP
NASAL
HIGH FLOW
OXYGEN
THERAPY
Commercially
available
circa 2001
Growing research
Number of NHF papers published from 2000-2013
(Neonatal and Pediatric)
40
Manley et al.
N Engl J Med
2013
35
number of papers
3 Randomised
Controlled Trials
(RCTs)
30
Yoder et al.
Pediatrics
2013
25
20
15
Collins e
t al.
J. Pediat
r.
2013
10
5
0
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
n = 867
Whats
behind the
momentum?
The literature indicates that
the momentum stems from
these therapy attributes:
Effective
Gentle
Easy
Effective
Gentle
Easy
Similar efficacy
to CPAP
Clinical studies have shown
that nasal high flow has similar
efficacy to nCPAP.1,2,3
* Study populations weighted towards infants >26 weeks gestational age,
post extubation
1 Refs here
Effective
Gentle
Easy
Associated with
reduced escalation
and length of stay
ACUITY
LENGTH OF STAY
1 Refs here
Effective
Gentle
Easy
1 Refs here
Effective
Gentle
Easy
No significant difference
in adverse events
Clinical studies have concluded that there
appears to be no significant difference in
other serious adverse events such as
pneumothorax when compared to nCPAP.1,2,3
1 Refs here
Effective
Gentle
Easy
Improved bonding
Surveys of practice describe
improved mother infant bonding
with NHF.1,2,3
1 Refs here
10
Effective
Gentle
Easy
Comfortable and
well tolerated
Research and surveys of practice
indicate improved comfort,1 tolerance
and patient satisfaction with NHF.2,3,4
1 Refs here
11
Effective
Gentle
Easy
Simpler application
Surveys of practice describe
easier application and ongoing
care with NHF.1,2,3
1 Refs here
12
Effective
Gentle
Easy
Empowers parents
Parents have confidence to play a greater
role in their infants care. Parents reported
a preference for NHF in a randomised cross
over trial involving 20 infants.1 These findings
are mirrored in surveys of practice.2,3,4
1 Refs here
13
Effective
Gentle
Easy
Loved by caregivers
Surveys of practice describe
improved caregiver satisfaction.1,2,3
1 Refs here
14
Summary
Effective
Gentle
Easy
15
ACUITY
$
LENGTH OF STAY
Avoiding intubation
16
ACUITY
LENGTH OF STAY
Avoiding intubation
14 30% reduction in
intubation rate associated
with the introduction of NHF.1,2
17
Broader
range of
flows
In-built
safety
features
Effective
Enhancing
comfort
Gentle
Easy
Promoting
developmental
care
Simpler
for
caregivers
Further
empowers
parents
18
INVASIVE
VENTILATION
OXYGEN
THERAPY
nCPAP
Effective
Gentle
Easy
19
20
Clinical
Definition
What is it?
Blended
gas
Optimal
flow
Heated
and
humidified
gas
Open
system
nCPAP
NHF/Optiflow Junior
Oxygen therapy
Sealed
Heated and humidified
Pressures prescribed
Flows typically
6-10 L/m
Non-sealed
Heated and humidified
Flow capabilities:
Neonatal up to 8 L/m,
Pediatric up to 25 L/m
Non-sealed
Cold, dry medical gas
Flows less than 2 L/m
Clinical
Mechanisms
How it works
Respiratory
Support
Airway
Hydration
Comfort
Respiratory support
REDUCTION OF
DEAD SPACE
Clearance of expired air in
the upper airways1,2
Increases
alveolar ventilation1,2
1 Mundel T, et al. J Appl Physiol. 2013. 2
Respiratory support
DYNAMIC POSITIVE
AIRWAY PRESSURE
Increases
alveolar ventilation1
AIRWAY PRESSURE
Respiratory
support with
Nasal High
Flow
Unassisted breathing
TIME
1 Mundel T, et al. J Appl Physiol. 2013. 2 Wilkinson et al. J Perinatol. 2008. 3 Arora et al. Pediatr Emerg Care. 2012.
Respiratory support
SUPPLEMENTAL
OXYGEN
Accurate delivery of blended,
humidified oxygen1
Enhances confidence in
oxygen administration
Airway hydration
OPTIMAL
HUMIDITY
Enables comfortable delivery
of high flows1
Prevents desiccation of
the airway epithelium2,3
Improves
mucus clearance2
1 Roca O, et al. Respir Care. 2010. 2
Comfort
EASE OF USE
OPEN SYSTEM
No seal required
Patient
comfort1,2
10
Physiological outcomes
In neonates:
In pediatrics:
NHF is associated
with:1,2
Clinically similar
work of breathing
compared to
nCPAP.1,2
11
Clinical outcomes
In neonates:1,2,3
In pediatrics:4,5
length of stay.
*Study populations weighted towards infants >26 weeks gestational age, post extubation
1 Collins et al. J. Pediatr. 2013. 2 Manley et al. New Engl J Med. 2013. 3
4
12
Tools
Neonatal usage
What flows should I use
for neonatal patients?
FLOW
BASED
DOSE BY
WEIGHT
TITRATE
TO EFFECT
(OBSERVATIONAL)
COMBINE
2 AND 3
1 Refs here
FLOW
BASED
DOSE BY
WEIGHT
TITRATE
TO EFFECT
(OBSERVATIONAL)
COMBINE
2 AND 3
FLOW
BASED
DOSE BY
WEIGHT
TITRATE
TO EFFECT
(OBSERVATIONAL)
COMBINE
2 AND 3
4 Yoder et al.
Pediatrics. 2013.
Supporting evidence
1 Collins et al.
J. Pediatr. 2013.
FIXED
FLOW
2 Milsi et al.
Int Care Med. 2013.
WEIGHT
BASED
3 Manley et al.
N Engl J Med. 2013.
AT THE
CLINICIANS
DISCRETION
Infants receiving
flows 2 L/kg/min
demonstrated
rapid unloading of
respiratory muscles.*
* As of February 2014
there are currently no
RCTs that have evaluated
a l/kg/min approach in
the neonatal population.
4 Yoder et al.
Pediatrics. 2013.
COMBINE
2 AND 3
Below is a visual summary of the flow ranges used in the 3 RCTs published in 2013.
The studies below use starting flows between 3 and 8 L/min.
NEONATAL
Flow
Guidance
source
Category
description
Collins et al
2013
Manley et al
2013
Premature and
neonatal cannula
10
11
Infant, intermediate
infant cannula
Pediatric cannula
Yoder et al
2013
<2kg
2-3kg
>3kg
KEY:
= Minimum flow
= Starting flow
= Maximum flow
Conclusions
The literature provides a good source of guidance on how to set and titrate flow.
The study by Yoder et al, 2013 provides the most detailed guide to managing nasal high
flow in the context of an RCT. It may be a useful tool in developing your own protocol.
FLOW
BASED
DOSE BY
WEIGHT
TITRATE
TO EFFECT
(OBSERVATIONAL)
COMBINE
2 AND 3
Tools
Pediatric usage
What flows should I use for bigger
babies and pediatric patients?
Pediatric usage
Tools
Pressure
Ive got questions
about pressure
Concern
Pressure
Considerations
Clinical data
Designed with in-built
safety features
Proactive monitoring/
management
11
Clinical data
Pressures are
typically low
Similar to nCPAP
The evidence from 3 RCTs, including over 800 babies,
suggests that nasal high flow is associated with a
similar risk of barotrauma compared to nCPAP.1,2,3
Pressures generated
12
Open
system
Patients vent flow and
pressure around the cannula.
In addition patients can
open their mouths.
Pressure
relief valve
Designed to allow flow and pressure
to vent from the circuit in case of the
unlikely scenario where the prongs
completely occlude the nares and
the mouth is held closed.
13
Proactive monitoring/management
Prong to
nare ratio
Sivieri et al. 20121 demonstrated
the importance of prong to nare
ratio as a key safety feature.
CHECKLIST
Ensure a clear gap
is visible around
each prong
No forced mouth
closure
Pressure relief valve
in place
14
Summary
Considerations
Clinical data
Similar to nCPAP
Pressures are typically low
Designed with in-built safety features
Open system
Pressure relief valve
Proactive monitoring/management
Prong to nare ratio
No forced mouth closure
15
Tools
Economics
The emerging health
economic benefits
ACUITY
$
LENGTH OF STAY
Avoiding intubation
17
ACUITY
LENGTH OF STAY
Avoiding intubation
14 30% reduction in
intubation rate associated
with the introduction of NHF.1,2
18
Tools
Economics
Optiflow Junior
v The BC Cannula
$
Product
The BC Cannula
$
Optiflow
Junior
20
$
Patient
outcomes
Product
The BC Cannula
Optiflow
Junior
Specifically
contoured for
Juniors delicate
anatomical
features.
-$?
21
$
Patient
outcomes
Product
The BC Cannula
Optiflow
Junior
+
Specifically
contoured for
Juniors delicate
anatomical
features.
-$?
Reduced time
to fit.*
No additional
tape costs.
-$?
* Result found in internal Fisher & Paykel Healthcare testing compared to an F&P BC Cannula.
22
$
Patient
outcomes
Product
Therapy
The BC Cannula
Optiflow
Junior
+
Specifically
contoured for
Juniors delicate
anatomical
features.
-$?
+
> Flow range =
broader scope
of therapy from
one device.
Reduced time
to fit.*
No additional
tape costs.
-$?
-$?
* Result found in internal Fisher & Paykel Healthcare testing compared to an F&P BC Cannula.
23
$
Patient
outcomes
Product
Developmental care
and patient journey
Therapy
The BC Cannula
Optiflow
Junior
+
Specifically
contoured for
Juniors delicate
anatomical
features.
-$?
+
> Flow range =
broader scope
of therapy from
one device.
Reduced time
to fit.*
No additional
tape costs.
-$?
-$?
-$?
* Result found in internal Fisher & Paykel Healthcare testing compared to an F&P BC Cannula.
24
$
Patient
outcomes
Product
Developmental care
and patient journey
Therapy
Total
system cost
The BC Cannula
Optiflow
Junior
+
Specifically
contoured for
Juniors delicate
anatomical
features.
-$?
+
> Flow range =
broader scope
of therapy from
one device.
Reduced time
to fit.*
No additional
tape costs.
-$?
-$?
= $?
Easier developmental care
(e.g. longer circuit).
-$?
= $?
* Result found in internal Fisher & Paykel Healthcare testing compared to an F&P BC Cannula.
25
Tools
Economics
Optiflow Junior
v nCPAP
$
Product
nCPAP
$
Optiflow
Junior
27
$
Patient
outcomes
Product
nCPAP
$
Optiflow
Junior
$
1
+
NHF
associated
with reduced
risk of nasal
trauma.1,2,3
+ -$?
28
$
Patient
outcomes
Product
nCPAP
$
Optiflow
Junior
$
1
+
NHF
associated
with reduced
risk of nasal
trauma.1,2,3
+ -$?
-$?
29
$
Patient
outcomes
Product
Therapy
nCPAP
$
Optiflow
Junior
$
1
+
NHF
associated
with reduced
risk of nasal
trauma.1,2,3
+ -$?
+
Faster to apply and
easier for cares.
Improved nursing
satisfaction.1,4,5,6
Can also be
used to deliver
heated and
humidified
oxygen therapy
(range of flows).
-$?
-$?
30
$
Patient
outcomes
Product
Developmental care
and patient journey
Therapy
nCPAP
$
Optiflow
Junior
$
1
+
NHF
associated
with reduced
risk of nasal
trauma.1,2,3
+ -$?
+
Faster to apply and
easier for cares.
Improved nursing
satisfaction.1,4,5,6
-$?
Easier developmental
care, less visually
intrusive. Empowers
parents.
Can also be
used to deliver
heated and
humidified
oxygen therapy
(range of flows).
-$?
-$?
31
$
Patient
outcomes
Product
Developmental care
and patient journey
Therapy
Total
system cost
nCPAP
$
Optiflow
Junior
$
1
+
NHF
associated
with reduced
risk of nasal
trauma.1,2,3
+ -$?
+
Faster to apply and
easier for cares.
Improved nursing
satisfaction.1,4,5,6
-$?
-$?
= $?
Easier developmental
care, less visually
intrusive. Empowers
parents.
Can also be
used to deliver
heated and
humidified
oxygen therapy
(range of flows).
-$?
= $?
32
Tools
Economics
Summary
Economics summary
$
Patient
outcomes
Product
Developmental care
and patient journey
Therapy
Total
system cost
nCPAP
Optiflow Junior
34
Tools
Project background
In 2009 existing
cannula designs
left room for
improvement.
Opportunity to improve:
Flow range
Condensate control
Prong design
Retention mechanism
Tubing design
Speed and ease of application
1 Refs here
36
Observation
Interacting with customers
Embedded our engineers in 50
hospitals around the world to look,
listen and learn
Design
Engineering concepts
Patient studies, research &
concept development
Customer needs
Clinical trials
Production
Manufacture
chosen concept
37
Customer needs
Customer feedback
CLINICIAN: I want to be able to
deliver higher flows
NURSE:
PARENT:
I want to be able to
see my babys face
BABY:
Make me better
Let me sleep
Effective
Gentle
Easy
Increased safety
Enhanced facilitation
of developmental
care
Improved
comfort
Improved ease
of use for parent
and clinician
38
39
Tools
Unique features
Optiflow delivers:
Enhanced therapy
Effective
Gentle
Easy
Wide
flow range =
broad scope
of therapy from
one device
*
*
*
*
41
Optiflow delivers:
Effective
Gentle
Easy
Breathable
FlexiTube
designed to
minimise
condensate
Soft
ergonomic
prong design
to minimise
risk of septal
damage
Kink-proof
FlexiTube
Easy-click
connector swivels
to untangle
tubing without
disconnecting
flow
42
Optiflow delivers:
Effective
Gentle
Easy
Insulating
sleeve to
minimize
condensate
43
Optiflow delivers:
Effective
Gentle
Easy
Long
circuit for easy
kangaroo
care
Soft
unobtrusive
design facilitates
developmental
care
44
Optiflow delivers:
Effective
Gentle
Easy
Wigglepad
attachment
for optimal
comfort
Soft prong
design to
minimise risk
of nasal
trauma
Anatomicallyshaped prongs
to fit developing
airway
45
Optiflow delivers:
Effective
Gentle
Easy
Wigglepad
velcro allows
easy re-application,
adjustment and
maintenance
Long circuit
for flexiblity
in cares and
placement
46
Optiflow delivers:
Effective
Gentle
Easy
Clothing
clip to assist
feeding
Long
circuit
for easy
feeding
47
Optiflow Junior
Enhancing the
established benefits of
nasal high flow therapy
Effective
Gentle
Easy
48
Award-winning
Optiflow Junior
49
Tools
Videos
Videos
Optiflow
Junior wins
Best Design
Award
Optiflow
Junior
fitting guide
51
Appendix
Introduction
The therapy
and Optiflow Junior
(CONCISE)
Overview
Avoid intubation
NEONATAL
Readmission
ACUITY
LENGTH OF STAY
Shorten length-of-stay
(to free up beds)
PEDIATRIC
Readmission
ACUITY
Control costs
Avoid readmission
LENGTH OF STAY
A therapy arrives...
THE RESPIRATORY CARE CONTINUUM
INVASIVE
VENTILATION
nCPAP
NASAL
HIGH FLOW
OXYGEN
THERAPY
Commercially
available
circa 2001
Growing research
Number of NHF papers published from 2000-2013
(Neonatal and Pediatric)
40
Manley et al.
N Engl J Med
2013
35
number of papers
3 Randomised
Controlled Trials
(RCTs)
30
Yoder et al.
Pediatrics
2013
25
20
15
Collins e
t al.
J. Pediat
r.
2013
10
5
0
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
n = 867
Whats
behind the
momentum?
The literature indicates that
the momentum stems from
these therapy attributes:
Effective
Gentle
Easy
Similar efficacy
to nCPAP1,2,3
Associated with
Effective
1,2,3
Less nasal trauma
reduced escalation
and length of stay4,5
No significant
difference in
adverse events1,2,3
Improved
bonding6,7,8
Simpler
Gentle
application6,7,8
Easy
Comfortable and
well tolerated
6,7,8
Empowers
parents9
Caregiver
satisfaction6,7,8
1 Collins et al. J Pediatr. 2013. 2 Manley et al. New Engl J Med. 2013. 3 Yoder et al. Pediatrics. 2013. 4 McKiernan et al. J Pediatr. 2010.
5 Schibler et al. Int Care Med. 2011. 6 Hochwald et al. J Neonatal Perinatal Med. 2010. 7 Hough et al. J Paediatr Child Health. 2011.
8
1 Ojha
al. Acta Paediatr. 2012. 9 Klingenburg at al. Arch Dis Child Fetal Neonatal Ed. 2013.
here
Refs et
ACUITY
$
LENGTH OF STAY
Avoiding intubation
ACUITY
LENGTH OF STAY
Avoiding intubation
14 30% reduction in
intubation rate associated
with the introduction of NHF.1,2
10
Broader
range of
flows
In-built
safety
features
Effective
Enhancing
comfort
Gentle
Easy
Promoting
developmental
care
Simpler
for
caregivers
Further
empowers
parents
11
INVASIVE
VENTILATION
OXYGEN
THERAPY
nCPAP
Effective
Gentle
Easy
12
13
Introduction
ACUITY
Readmission
LENGTH OF STAY
L&D
NICU
WARD
HOME
Early use
AIMS TO:
AIMS TO:
15
ACUITY
Readmission
LENGTH OF STAY
ED
PICU
WARD
HOME
Early use
AIMS TO:
AIMS TO:
16
Introduction
Other evidence
NEONATAL
Guidance
source
Category
description
Collins et al
2013
Manley et al
2013
Premature and
neonatal cannula
= Minimum flow
= Starting flow
= Maximum flow
Flow
1
10
11
Infant, intermediate
infant cannula
Pediatric cannula
Yoder et al
2013
<2kg
2-3kg
>3kg
PEDIATRIC
Milsi et al
2013
Weight range
2.6 7.3kg
18
Growing
usage
Published
surveys
of practice
Australia/NZ USA
UK
Users:
Evidence of increasing use in clinical practice (ANZNN Report)
Findings:
19