In this cross-sectional study, which was approved by the Ethics Committee of Mashhad University of Medical Sciences (IR.MUMS.MEDICAL.REC.1398.637), a total of 66 patients requiring intubation, who were referred to three academic hospitals of Mashhad University of Medical Sciences (Emam Reza, Ghaem, and Hasheminejad hospitals) from October 2018 to October 2019, were enrolled based on the inclusion criteria. The study objectives were explained to the patients’ legal guardians, and they were enrolled in the study after obtaining informed consent. The inclusion criteria were patients over 18 years, who required prophylactic airway management with endotracheal intubation in the ED. On the other hand, the exclusion criteria were as follows: (1) an abnormal airway anatomy, (2) difficult intubation, (3) cardiorespiratory arrest, (4) significant cervical trauma, (5) cervical abnormality, and (6) tracheal or endobronchial lesions.
An emergency medicine physician assistant, during an anesthesia rotation, performed patient intubation. Another assistant responsible for the project performed suprasternal ultrasounds with a curvilinear probe on the suprasternal area; within two seconds after intubation, its accuracy was determined. The tube passage through the trachea created the Comet tail sign, hyperechoic shadow, bullet sign, and circular hypodense space on ultrasound. However, if the tube was in the esophagus, no hypodense space was seen, or the ETT tube was observed outside the trachea.
Immediately after suprasternal sonography, the assistant performed subxiphoid sonography with a diaphragmatic motion within five seconds, and information was recorded. It should be emphasized that two individuals performed intubation and sonography independently and that neither of them were aware of the other person’s performance to avoid biased results. Along with ultrasound, other methods of ETT placement confirmation, including observation of tube passage through the vocal cords by a clinician, capnography, and auscultation (all three methods), were used as the gold standards, and the results were recorded.
If all or two of the three methods, including capnography, were positive (confirmation of correct tube placement), the result of the gold standard method was considered positive; other results were considered negative. If the result of the gold standard method was positive and correct tube placement was confirmed by suprasternal or subxiphoid sonography, the result was considered true positive; however, if it was not confirmed by sonography, it was considered a false negative result. If the tube was placed correctly, the patient's treatment process continued. Otherwise, after correction, treatment continued according to the standard protocol. The patients’ demographic data form (i.e., age, sex, BMI, history of smoking, and diabetes) was also completed and recorded.
3.1. Sample Size and Statistical Analysis
The sample size of this study was determined based on a study by Lahham et al. (
15) at an alpha of < 0.05, with an accurate intubation rate of 70% according to previous studies. At an ultrasound sensitivity of 97%, an approximate sample size of 64 patients was measured, and finally, 70 patients were recruited considering a 10% dropout rate:
Descriptive statistical methods, such as mean, standard deviation, frequency, and frequency percentage, were used to describe the data. Sensitivity, specificity, positive predictive value, (PPV), negative predictive value (NPV), positive likelihood ratio, and negative likelihood ratio were also measured to evaluate the diagnostic value of ultrasonography relative to capnography. The diagnostic odds ratio (DOR) was also calculated to evaluate the performance of ultrasound compared to capnography. Statistical analysis was performed in STATA version 12 (StataCorp LLC, College Station, TX, USA), and the significance level was considered to be less than 0.05.