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

Abstract

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.

Keywords: Endotracheal tube (ETT); Intubation; Newborn resuscitation; Pakistan; Point of care ultrasound (POCUS); Simulation.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1

Low-cost ultrasound simulator. a The beef gelatine and psyllium fiber block, with cut-off 10 mL syringe barrel. b With cut-off 10 mL syringe barrel being used to create staggered hollow cylinders within the block. c Block with staggered hollow cylinders, with retained plug from cylinder creation. More superior cylinder is simulated trachea (white arrow), and more inferior cylinder is simulated esophagus (black arrow). d Plug partial insertion into more inferior cylinder (model esophagus)

Fig. 2

Ultrasound images on the model: Tracheal Intubation. a Static ultrasound image of a patient with the ETT in the trachea, with linear ultrasound probe held in transverse orientation over the anterior neck at the level of the sternal notch. b & c Static ultrasound images of beef gelatine model with plug inserted into simulated esophagus, simulating the ultrasound appearance of a tracheal intubation

Fig. 3

Ultrasound images on the model: Esophageal Intubation. a Static ultrasound image of an esophageal intubation in a patient, with linear ultrasound probe held in transverse orientation over the anterior neck at the level of the sternal notch. b & c Static ultrasound images of beef gelatine model with plug removed from simulated esophagus, simulating the ultrasound appearance of an esophageal intubation

Fig. 4

Placement of the probe on the Simulator. a The first image shows placement of linear probe over the side of the model to obtain images in transverse plane. b Demonstrates a towel with a square hole of 1 X 3 cm and c Shows the towel is placed over the beef gelatin model to hide the location of the plug from the ultrasound operator

Fig. 5

Objective Structured Assessment of Technical Skills

Fig. 6

Learner Evaluation Form

Fig. 7

Learner Demographic Form

Fig. 8

Learner feedback form

Fig. 9

Patient Data Collection Form