A novel training simulator for portable ultrasound identification of incorrect newborn endotracheal tube placement - observational diagnostic accuracy study protocol.

BACKGROUND: Endotracheal tube (ETT) placement is a critical procedure for newborns that are unable to breathe. Inadvertent esophageal intubation can lead to oxygen deprivation and consequent permanent neurological impairment. Current standard-of-care methods to confirm ETT placement in neonates (auscultation, colorimetric capnography, and chest x-ray) are time consuming or unreliable, especially in the stressful resuscitation environment. Point-of-care ultrasound (POCUS) of the neck has recently emerged as a powerful tool for detecting esophageal ETTs. It is accurate and fast, and is also easy to learn and perform, especially on children. METHODS: This will be an observational diagnostic accuracy study consisting of two phases and conducted at the Aga Khan University Hospital in Karachi, Pakistan. In phase 1, neonatal health care providers that currently perform standard-of-care methods for ETT localization, regardless of experience in portable ultrasound, will undergo a two-hour training session. During this session, providers will learn to detect tracheal vs. esophageal ETTs using POCUS. The session will consist of a didactic component, hands-on training with a novel intubation ultrasound simulator, and practice with stable, ventilated newborns. At the end of the session, the providers will undergo an objective structured assessment of technical skills, as well as an evaluation of their ability to differentiate between tracheal and esophageal endotracheal tubes. In phase 2, newborns requiring intubation will be assessed for ETT location via POCUS, at the same time as standard-of-care methods. The initial 2 months of phase 2 will include a quality assurance component to ensure the POCUS accuracy of trained providers. The primary outcome of the study is to determine the accuracy of neck POCUS for ETT location when performed by neonatal providers with focused POCUS training, and the secondary outcome is to determine whether neck POCUS is faster than standard-of-care methods. DISCUSSION: This study represents the first large investigation of the benefits of POCUS for ETT confirmation in the sickest newborns undergoing intubations for respiratory support. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03533218. Registered May 2018.

Diagnostic accuracy of point-of-care ultrasound compared to standard-of-care methods for endotracheal tube placement in neonates.

INTRODUCTION: Point-of-care ultrasound (POCUS) is a valuable tool to determine endotracheal tube (ETT) placement; however, few studies have compared it with standard confirmation methods. We evaluated the diagnostic accuracy of POCUS and time-to-interpretation for correct identification of tracheal versus esophageal intubations compared to a composite of standard-of-care methods in neonates. METHODS: A cross-sectional study was conducted in the Neonatal Intensive Care Unit (NICU) at Aga Khan University Hospital Karachi, Pakistan. All required intubations were performed as per NICU guidelines. The clinical team simultaneously determined the ETT placement using standard-of-care methods (auscultation, colorimetric capnography, and chest X-ray) by POCUS. In addition, the clinical team was blinded to the POCUS images. Timings were recorded for each method by independent study staff. RESULTS: A total of 348 neonates were enrolled in the study. More than half (58%) of intubations were in an emergency scenario. POCUS user interpretation showed 100% sensitivity and 94% specificity using an expert as the reference standard. We found a 99.4% agreement (Kappa: 0.96; p < 0.001). Diagnostic accuracy of POCUS compared with at least two standard-of-care methods demonstrated 99.7% sensitivity, 91% specificity, and 98.9% agreement (Kappa:0.93; p < 0.001). The median time required for POCUS interpretation was 3.0 (interquartile range [IQR] 3.0-4.0) seconds for tracheal intubation. The time recorded for auscultation and capnography was 6.0 (IQR 5.0-7.0) and 3.0 (IQR 3.0-4.0), respectively. CONCLUSION: POCUS is a rapid and reliable method of identifying ETT placement in neonates. Early and correct identification of airway management is critical to save lives and prevent mortality and morbidity.