A multicentre, randomised trial of stabilisation with nasal high flow during neonatal endotracheal intubation (the SHINE trial): a study protocol

Abstract

IntroductionNeonatal endotracheal intubation is an essential but potentially destabilising procedure. With an increased focus on avoiding mechanical ventilation, particularly in preterm infants, there are fewer opportunities for clinicians to gain proficiency in this important emergency skill. Rates of successful intubation at the first attempt are relatively low, and adverse event rates are high, when compared with intubations in paediatric and adult populations. Interventions to improve operator success and patient stability during neonatal endotracheal intubations are needed. Using nasal high flow therapy extends the safe apnoea time of adults undergoing upper airway surgery and during endotracheal intubation. This technique is untested in neonates.Methods and analysisThe Stabilisation with nasal High flow during Intubation of NEonates (SHINE) trial is a multicentre, randomised controlled trial comparing the use of nasal high flow during neonatal intubation with standard care (no nasal high flow). Intubations are randomised individually, and stratified by site, use of premedications, and postmenstrual age (<28 weeks’ gestation; ≥28 weeks’ gestation). The primary outcome is the incidence of successful intubation on the first attempt without physiological instability of the infant. Physiological instability is defined as an absolute decrease in peripheral oxygen saturation >20% from preintubation baseline and/or bradycardia (<100 beats per minute).Ethics and disseminationThe SHINE trial received ethical approval from the Human Research Ethics Committees of The Royal Women’s Hospital, Melbourne, Australia and Monash Health, Melbourne, Australia. The trial is currently recruiting in these two sites. The findings of this study will be disseminated via peer-reviewed journals and presented at national and international conferences.Trial registration numberACTRN12618001498280.

In Newborn Infants a New Intubation Method May Reduce the Number of Intubation Attempts: A Randomized Pilot Study

“…Our standard operating procedure is based on a randomized controlled trial demonstrating no differences in heart rate when using the Propofol compared to the morphine, atropine, and suxam-ethonium regimen [ 5 ]. The SHINE trial is currently comparing the addition of a high-flow nasal cannula with standard care during neonatal intubation with a similar primary outcome (i.e., incidence of successful first attempt intubation without physiological instability) [ 6 ].…”

The SHINE trial (a multicentre, randomised trial of stabilisation with nasal high flow during neonatal endotracheal intubation): statistical analysis plan

“…Definitions and secondary outcomes are further outlined in Section 6 and in the trial protocol [ 2 ].…”

“…Any patient undergoing endotracheal intubation in the DR or NICU is eligible for inclusion. Specific inclusion and exclusion criteria are outlined in the protocol [ 2 ].…”

The SHINE Trial (A Multicentre, Randomised Trial of Stabilisation with Nasal High Flow During Neonatal Endotracheal Intubation): Statistical Analysis Plan

“…Any patient undergoing endotracheal intubation in the DR or NICU is eligible for inclusion. Speci c inclusion and exclusion criteria are outlined in the protocol [2].…”

“…Nasal HF during the endotracheal intubation attempt, or 2. Standard care (no nHF during the endotracheal intubation attempt) Full explanation of the trial design is included in the trial protocol [2].…”