Prehospital airway management in the pediatric patient: A systematic review.

BACKGROUND: Critically ill children may require airway management to optimize delivery of oxygen and ventilation during resuscitation. We performed a systematic review of studies comparing the use of bag-valve-mask ventilation (BVM), supraglottic airway devices (SGA), and endotracheal intubation (ETI) in pediatric patients requiring prehospital airway management. METHODS: We searched Ovid MEDLINE, EMBASE, and Cochrane databases for papers that compared SGA or ETI to BVM use in children, including studies that reported survival outcomes. We followed the Preferred Reporting Items in Systematic Reviews and Meta-Analyses (PRISMA) guidelines and assessed study quality using the Newcastle-Ottawa Scale. We compared key characteristics of the candidate papers, including inclusion criteria, definitions of airway interventions, and association with outcomes. RESULTS: Of 773 studies, eight met criteria for inclusion. Only one study was a randomized controlled trial; the other seven studies were observational. Four studies compared ETI to BVM, two studies compared SGA to BVM, one study compared ETI to SGA, and two studies compared advanced airway management (AAM) to BVM. Primary outcomes varied, ranging from overall mortality and 24-h mortality to 1-month survival, hospital survival, and neurologically favorable survival. Four of the studies found no difference in survival with the use of ETI, and four found increased mortality with the use of ETI. Associations with outcomes could not be assessed by meta-analysis due to limited number of studies and the wide variation in the design, population, interventions, and outcome measures of the included studies. CONCLUSIONS: In this systematic review, studies of prehospital pediatric airway management varied in scope, design, and conclusions. There was insufficient evidence to evaluate efficacy of pediatric prehospital airway management; however, the current research suggests that there are equal or worse outcomes with the use of ETI compared to other airway techniques. Additional clinical trials are needed to assess the merits of this practice.

Obstetrical randomized controlled trials: individuals screened, approached, and enrolled.

BACKGROUND: The use of randomized clinical trials (RCTs) is predicated on the idea that the study group is representative of the overall clinical population; however, recent studies have suggested that this may not be the case in obstetrics.1,2 The generalizability of several seminal obstetrical RCTs, including the A Randomized Trial of Induction Versus Expectant Management trial, has been questioned because of the high ratio of assessed-to-enrolled individuals.3 Although difficulty in recruitment for obstetrical RCTs is known,4 it has been postulated that this high ratio increases the likelihood of the study population not being truly representative. Our primary objective was to analyze the assessed-to-enrolled ratio in contemporary obstetrical RCTs. STUDY DESIGN: During a 4-year period (January 2017 to December 2020), we identified all obstetrical RCTs published in 6 journals (The New England Journal of Medicine, Journal of the American Medical Association, Lancet, American Journal of Obstetrics & Gynecology, British Journal of Obstetrics and Gynaecology, and Obstetrics & Gynecology). The journals were manually reviewed by 2 coauthors to ensure all obstetrical RCTs were identified and abstracted accurately. Reported patient recruitment data, per Consolidated Standards of Reporting Trials recommendations,5 were abstracted from each RCT. Based on the primary outcome of the study, the purpose of the trial was categorized as preventative or treatment. Medians were compared using Wilcoxon rank-sum testing, and P<.05 was considered significant. RESULTS: Of 240 obstetrical RCTs that were identified, 193 (80%) reported data on the number of individuals screened and recruited. The median number of individuals screened per trial was 850 (interquartile range [IQR], 323-2582), of which 348 were eligible (IQR, 201-1347) and 300 (IQR, 133-894) were randomized. There was no difference in trials based internationally or in the United States (P=.26). Compared with preventative RCTs, the trials that had treatment as the primary outcome were significantly more likely to screen a larger number of individuals for eligibility (P<.01) and subsequently randomize (P<.02). There was no difference in the median number of individuals who declined enrollment between trials with prevention or treatment as their objective (P=.12). More individuals were lost to follow-up in trials with prevention as the primary outcome (P<.01), although the median number lost was low at 3 (IQR, 0-21). CONCLUSION: The low assessed-to-enrolled ratio found in this study suggested that researchers are casting a large net for patient recruitment. The relatively high eligible-to-randomized ratio suggested that most individuals are willing to participate in obstetrical RCTs. This finding was at odds with previous critiques of obstetrical RCTs that had called in to question study results secondary to high eligible-to-randomized ratios. Further research into how patients are recruited and counseled is indicated, to explore this variation. The ratio of patients assessed for study eligibility to patients enrolled in preventative vs treatment RCTs was not substantially different. Based on this result, patients seemed to be similarly interested in being enrolled to prevent a complication from pregnancy as in treating one. These results supported the concept that most individuals in the obstetrical RCTs represent the eligible population.