Design and Superior Performance of a New Endotracheal Tube to Avoid the Asphyxiation of Premature Infants.

Background Neonatal endotracheal intubation attempts often fail, with failures typically attributable to unintended esophageal intubation, with asphyxia, brief or prolonged, as the consequence. Standard-of-care neonatal endotracheal tubes have changed little over recent decades, even as the gestational age of neonates thought eligible for resuscitation and intensive care has decreased. Methods A new neonatal endotracheal tube was patterned after the soft steering mechanism of a two-string fishing line trocar. The new tube remains patent throughout the intubation for air movement and CO2 detection and allows for a finger on the intubator's hand to stiffen, curve, and elevate the tip of the tube over the epiglottis and into the trachea without occluding the vision through a laryngoscope. This tube's engineering principles were studied prospectively in a controlled open-label pilot study in premature infants. Infants were observed during 12 intubations in a one-to-one comparison with standard practice.  Results The new design in comparison to a conventional neonatal endotracheal tube (CNETT) was found to be superior. The average intubation time (mean 36.6 sec, median 30 sec) was shorter (mean 44.6 sec, median 45 sec) in the new design. Intubation attempts were fewer (0 vs. 3), and unintended esophageal intubations were also fewer (0 vs. 4). Conclusion Tracheal intubation of premature infants with the new soft-steering mechanism endotracheal tube was associated with less asphyxia, fewer intubation attempts, and fewer esophageal intubations.

Comparative rates of harms in randomized trials from more developed versus less developed countries may be different.

OBJECTIVES: We set up to evaluate the relative risk of harms in trials performed in less developed vs. more developed countries. STUDY DESIGN AND SETTING: Meta-epidemiologic evaluation using the Cochrane Database of Systematic Reviews. We considered meta-analyses with at least one randomized clinical trial (RCT) in a less developed country and one RCT in a more developed country. We targeted severe adverse events (AEs), discontinuations due to AEs, any AE, organ system-specific AEs, individual AEs, and all discontinuations due to any reason. We estimated the relative odds ratio (ROR) of harms between more and less developed countries for each topic and the summary ROR (sROR) across topics under each category of harms. RESULTS: We identified 42 systematic reviews (128 meta-analyses, 521 independent RCTs). Summary sRORs did not differ significantly from 1.00 for any harm category. Nominally significant RORs were found in only 6/128 meta-analyses. However, in 27% (35/128) of meta-analyses the ROR point estimates indicated relative differences between country settings >2-fold. Considering also ROR 95% confidence intervals, in 92% (118/128) of meta-analyses one could not exclude a 2-fold difference in both directions. CONCLUSIONS: We identified limited comparative evidence on harms in trials from these two country settings. Substantial differences in the risk point estimates were common; the potential for modest differences could rarely be excluded with confidence.