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Ventilation Strategies in the DR

Question Type:
Intervention
Full Question:
Term and preterm newborn infants who do not establish spontaneous respiration at birth (P), does administration of one or more pressure-limited sustained lung inflations (I), compared with compared to intermittent PPV with short inspiratory times (C), change AGAR at 5 minutes, Establishment of functional residual capacity, Requirement for mechanical ventilation in first 72 hours, time to heart rate > 100 bpm, Rate of tracheal intubation, bystander CPR performance, overall mortality (O)?
Consensus on Science:
For the critical outcome of need for mechanical ventilation in the first 72 hours after birth, low-quality evidence (downgraded for inconsistency, indirectness, and imprecision) from 3 randomized clinical trials enrolling 404 newborns showed significant benefit of sustained lung inflations. (Harling 2005, F406; Lindner 2005, 303; Lista 2015, e457) In addition, very-low-quality evidence (downgraded for variability of interventions in SI and control populations) from 2 cohort studies with a total of 331 patients also showed benefit of sustained lung inflations as compared with intermittent PPV with short inspiratory times. (Lindner 1999, 961; Lista 2011, 45) One randomized clinical trial (te Pas 2007, 322) was excluded from analysis due to methodological concerns pertaining to differences in the various interventions between the study groups of which SLI was merely one. For the critical outcome of mortality, low-quality evidence (downgraded for indirectness and imprecision) from 3 randomized clinical trials enrolling 404 newborns(Harling 2005, F406; Lindner 2005, 303; Lista 2015, e457) and very-low-quality evidence (downgraded for variability of interventions in sustained lung inflation and control populations) from 2 cohort studies with a total of 331 patients showed no benefit as compared with IPPV with short inspiratory times.(Harling 2005, F406; Lindner 2005, 303) For the critical outcome of bronchopulmonary dysplasia, low-quality evidence (downgraded for inconsistency, indirectness, and imprecision) from 3 randomized clinical trials enrolling 404 patients showed no benefit. (Harling 2005, F406; Lindner 2005, 303; Lista 2015, e457) Very-low-quality evidence (downgraded for variability of interventions in SI and control populations) from 2 cohort studies with a total of 331 patients showed significant benefit of sustained lung inflations as compared with IPPV with short inspiratory times.(Lindner 1999, 961-967; Lista 2011, 45) For the critical outcome of air leak, low-quality evidence (downgraded for inconsistency, indirectness, and imprecision) from 3 randomized clinical trials enrolling 404 newborns(Harling 2005, F406; Lindner 2005, 303; Lista 2015, e457) and very-low-quality evidence (downgraded for variability of interventions in SI and control populations) from 2 cohort studies with a total of 331 patients showed no effect of sustained lung inflation as compared with IPPV with short inspiratory times.(Harling 2005, F406; Lindner 2005, 303) For the important outcome of Apgar score, there was no difference between groups in any studies reviewed. (Lindner 1999, 961; Harling 2005, F406; Lindner 2005, 303; Lista 2011, 45) For the important outcome of need for intubation, very-low-quality evidence (downgraded for lack of controls) from 1 cohort study (Lindner 1999, 961) showed that the need in the delivery room was significantly lower in infants who received an SI compared with conventional management. For the important outcome of heart rate greater than 100/min, no evidence was found. For the important outcome of establishment of FRC, no evidence was found. For the important outcome of FIO2 in the delivery room, no evidence was found. For the important outcome of chest compressions in the delivery room, no evidence was found. Additional comments: No human studies evaluated time to heart rate greater than 100/min, establishment of FRC, FIO2 in the delivery room, or need for chest compressions in the delivery room. In a small case series of 9 asphyxiated term infants (very-low-quality evidence), a prolonged initial inflation of 5 seconds produced a 2-fold increase in FRC compared with historic controls.(Vyas 1981, 635) Comparison of all studies (randomized clinical trials and cohort) was compromised due to the heterogeneity of methodology, ie, wide differences in duration of the initial SI (5–20 seconds) as well as the peak inspiratory pressure (20–30 cm H2O) and use of a variety of interface devices to deliver the SI (endotracheal tube, face mask, or nasopharyngeal tube). Three studies repeated the initial sustained lung inflation once,(Lindner 1999, 961; Lista 2011, 45; Lista 2015, e457) 1 at a higher positive inflating pressure,(Lindner 1999, 961) whereas 1 study repeated the SI twice with increasing positive inflating pressure.(Lindner 2005, 303) No studies compared the efficacy of a single SI with multiple SIs. Animal studies of the effects of SI on alveolar recruitment have shown in lambs (Klingenberg 2013, F222) and preterm rabbits (te Pas 2009, 295) more uniform lung inflation and better lung compliance, if animals received an SI before initiation of mechanical ventilation. However, a study by Klopping-Ketelaars (Klopping-Ketelaars 1994, 1017) showed no benefit after an initial SI in preterm lambs, and another study showed that stepwise increases in PEEP resulted in better overall lung mechanics than treatment with an initial SI. (Tingay 2014, 288)
Treatment Recommendation:
We suggest against the routine use of initial SI (greater than 5 seconds duration) for preterm infants without spontaneous respirations immediately after birth, but an SI may be considered in individual clinical circumstances or research settings (weak recommendation, low-quality evidence). Values, Preferences, and Task Force Insights In making this recommendation, and in the absence of long-term benefits, we place a higher value on the negative aspect involving lack of clarity as to how to administer sustained lung inflations versus the positive findings of a reduced need for intubation at 72 hours. Although the studies reviewed showed that administration of an SI reduced the need for mechanical ventilation in the first 72 hours of life, the use of SI did not change the incidence of important long-term outcomes related to lung function, including risk of bronchopulmonary dysplasia or overall mortality. Studies thus far are likely underpowered for these outcomes. There was much debate about the use of SI. The methods used in delivering SI varied among studies. It was stressed that different devices varied in their ability to generate pharyngeal pressures. Moreover, a recent animal study suggests that there may be unintended glottis closure associated with SI. There was also concern that the current wording of the treatment recommendation may be viewed by some as limiting the potential for future clinical studies. Evidence evaluators were asked to decide whether to include the te Pas article. (te Pas 2007, 322) The decision was made to exclude it because of multiple confounding interventions. It was thought that more detail in the consensus on science was needed to reflect that studies used SI ranging from 5 to 25 seconds. There was debate about the use of the wording suggest against. Several members were in favor of using this term, because there is insufficient evidence regarding how to administer sustained lung inflation, how many such breaths should be applied, or whether it should be used with or without PEEP. It is difficult to extrapolate from animal data, because the animals in the studies were nonbreathing and had tracheostomies, so that the anatomy, physics, and physiology are different. Although there was consensus agreement on the current wording, it was noted that individual councils may choose to interpret the recommendations differently.
CoSTR Attachments:
809 Risk of Bias.docx    
GRADE GRID - SI worksheet-2-3-15.docx    

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