GRADE GRID - SI worksheet-2-3-15

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Problem
Criteria
Is there a problem
priority?
Benefits & harms of the options
What is the overall
certainty of this evidence?
Judgements
○ No
○ Probably no
○ Uncertain
○ Probably yes
x Yes
○ Varies
Failure to establish FRC after delivery may result
in need for high pressure to inflate alveoli, which
may increase risk of chronic lung disease.
○ No included studies
○ Very low
○ Low
x Moderate
○ High
3 RCTs (Lindner 2005, Harling 2005, and Lista
2015) and one metanalysis (Schmolzer et al)
showed that preterm infants who were given one
or more sustained inflations immediately after
birth had a lower likelihood of endotracheal
intubation in the first 72 hours after birth than
infants who received standard treatment.
○ Important uncertainty or variability
○ Possibly important uncertainty or
Is there important
uncertainty about how
much people value the
main outcomes?
variability
○ Probably no important uncertainty of
variability
x○ No important uncertainty of
variability
○ No known undesirable
Are the desirable
anticipated effects large?
Research evidence
○ No
x○ Probably no
○ Uncertain
○ Probably yes
○ Yes
Three animal studies (tePas 2009, Sobotka 2011,
and Kingenberg 2012) showed that administration
of sustained inflations resulted in more rapid
establishment of FRC.
However, all four studies were downgraded for
imprecision, indirectness, or both.
Additional considerations
Criteria
Judgements
○ Varies
Are the undesirable
anticipated effects small?
Resour
ce use
Are the desirable effects
large relative to
undesirable effects?
Are the resources required
small?
○ No
○ Probably no
x○ Uncertain
○ Probably yes
○ Yes
○ Varies
○ No
x○ Probably no
○ Uncertain
○ Probably yes
○ Yes
○ Varies
○ No
○ Probably no
○ Uncertain
Research evidence
Additional considerations
Criteria
Judgements
Research evidence
Additional considerations
○ Probably yes
x○ Yes
○ Varies
Equity
Is the incremental cost
small relative to the net
benefits?
What would be the impact
on health inequities?
○ No
○ Probably no
○ Uncertain
x○ Probably yes
○ Yes
○ Varies
The equipment required is routinely
available
○ Increased
○ Probably increased
○ Uncertain
○ Probably reduced
○ Reduced
x○ Varies
Healthcare systems that could utilize
sustained inflations would very likely
have also have other available
methods for providing ventilatory
support. In low resource situations,
it is equally unlikely that sustained
inflations or other types of
respiratory support would be
available.
Feasibility
Acceptability
Criteria
Is the option acceptable to
key stakeholders?
Is the option feasible to
implement?
Judgements
Research evidence
Additional considerations
Some institutions report using sustained inflations
as standard of care. (eg, Lindner 1999 961)
Application of a sustained inflation
will briefly delay initiation of positive
pressure ventilation should the baby
not respond to the initial SI.
Four studies that used SI as part of the
experimental protocol did not report any problems
with implementation. (te Pas 2007 322, Lindner
1999 961, Lista 2011 45, Lista 2015 in press)
Some institutions report using SI
routinely in preterm infants
immediately after birth to establish
FRC (eg, Lindner 1999 961)
○ No
○ Probably no
○ Uncertain
x○ Probably yes
○ Yes
○ Varies
○ No
○ Probably no
○ Uncertain
○ Probably yes
x○ Yes
○ Varies
Recommendation
Balance of
consequences
Undesirable consequences
clearly outweigh desirable
consequences in most
settings
Undesirable consequences
probably outweigh desirable
consequences in most
settings
The balance between desirable
and undesirable consequences
is closely balanced or
uncertain
Desirable consequences
probably outweigh
undesirable consequences in
most settings
Desirable consequences
clearly outweigh undesirable
consequences in most
settings
○
○
○
○
○
Type of
recommendation
We recommend against offering this option
routinely
We suggest not offering this
option
We suggest offering this
option
We recommend offering this
option
x○
○
○
○
Recommendation
We suggest against routine use of sustained inflation to establish functional residual capacity in preterm infants who do not breathe spontaneously
immediately after birth
Justification
Although use of SI reduced the need for intubation in the first 72 hr, there is no evidence of long-term benefit, and there was considerable
variability among the studies reviewed. In addition, available data suggest that use of SI may increased the incidence of air leak.
Subgroup
considerations
Use of sustained inflations in extremely low birth weight/extremely immature newborns might result in pneumothorax
Implementation
considerations
There is no standardized method at present for delivering sustained inflations
Would not be able to be implemented in low-resource settings.
Monitoring and
evaluation
Babies who receive sustained inflations should be monitored for evidence of pneumothorax as well as for other complications of prematurity
Research possibilities
Studies to determine the optimal duration and pressure to use during sustained inflation; comparison of single vs multiple applications of sustained
inflations immediately after birth
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