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

Abstract

BackgroundEndotracheal 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.MethodsThis 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.DiscussionThis study represents the first large investigation of the benefits of POCUS for ETT confirmation in the sickest newborns undergoing intubations for respiratory support.Trial registrationClinicalTrials.gov Identifier: NCT03533218. Registered May 2018.

Simulator-based ultrasound training for identification of endotracheal tube placement in a neonatal intensive care unit using point of care ultrasound

“…The immediate postnatal period is the most vulnerable time in a newborn’ life where the majority of intubations take place to assist in the transition from fetal to neonatal life. Prompt interventions can prevent hypoxia and irreversible damage to the newborn’s developing brain [ 20 ].…”

“…We have previously described in detail the novel simulator that we used during the training sessions. Details of the simulator is presented in the previously published POCUS protocol paper [ 20 ]. The simulator can mimic the sonographic appearance of the anterior neck for both a correctly placed (tracheal) endotracheal tube (ETT) and an incorrectly placed (esophageal) ETT (Fig.…”

Review of simulation model for education of point-of-care ultrasound using easy-to-make tools

“…Furthermore, simulation education models possibly lower the learning curve of skill acquirement[ 2 , 9 - 12 ]. Nowadays, a large number of simulators have been developed and introduced[ 2 , 9 , 12 , 13 ]. However, the commercial simulator that has a sufficiently secured fidelity is expensive and not always available to trainees[ 2 , 9 , 12 , 13 ].…”

“…Nowadays, a large number of simulators have been developed and introduced[ 2 , 9 , 12 , 13 ]. However, the commercial simulator that has a sufficiently secured fidelity is expensive and not always available to trainees[ 2 , 9 , 12 , 13 ]. Pioneers in the medical field have developed inexpensive and easily made simulators for POCUS educational purposes, and have reported admirable educational achievements[ 2 , 13 - 16 ].…”

“…However, the commercial simulator that has a sufficiently secured fidelity is expensive and not always available to trainees[ 2 , 9 , 12 , 13 ]. Pioneers in the medical field have developed inexpensive and easily made simulators for POCUS educational purposes, and have reported admirable educational achievements[ 2 , 13 - 16 ]. An ideal simulator should be inexpensive, easily made, not be time-consuming to produce, has no infection issues, easily transportable, and has a reproducibility of the sonographic appearance and resistance that is similar to human tissue[ 2 , 9 , 17 ].…”