After the approval from Office of Human Research Ethics Committee, faculty of medicine, Prince of Songkla University (REC 60-188-08-4), this study was conducted at the operating theatre of Songklanagarind Hospital, Thailand, from March 2018 to October 2018. Subjects were chosen from the elective schedule of the operations which required general anesthesia with oroendotracheal tube (ETT). The eligible patients were 18–65 years old, had ASA physical status 1 to 3. The exclusion criteria were patients with deformities of chin, pharynx and/or larynx, base of skull lesion, neck mass, upper airway obstruction, abnormal prothrombin time, activated partial thromboplastin time and platelet disorder, esophageal stenosis or varices, history of radiotherapy in the head and neck region, unstable cervical spine, head injury, limit neck motion and previous esophageal surgery.
Written informed consent was obtained from each patient after discussion of the study procedure and expected complications. The patients were then randomized into 2 groups with 43 patients in each group. Group G (GlideScope™ visualization ), Group F (neck flexion with lateral pressure) using computerized random allocation soft-ware with opaque envelopes. Standard monitoring with continuous electrocardiography, non-invasive blood pressure monitoring, pulse oximetry and capnograph were used for all patients. After preoxygenation, nonrapid sequence of induction and intubation for anesthesia consists of administration of an induction agent, proof of the ability to mask ventilate, administration of a neuromuscular blocking agent (NMBA), and endotracheal intubation once paralysis is achieved. Intubation was performed with a cuffed, polyvinyl chloride endotracheal tube (7–8 mm internal diameter as per patient's size). The ETT cuff was inflated and the pressure kept between 15 and 25 cm H2O using a pressure gauge manometer. Anesthesia was maintained by sevoflurane/desflurane at an end-tidal concentration of one minimum alveolar anesthetic concentration. All patients were blinded, but we could not blind accessors and investigators. Three attending anesthesiologists was responsible for all NGT placements with the aim to reduce skill bias (our attendants had practiced the two methods of NGT insertion for two weeks (5 patients in each group) before the study began. And there are no differences of success rate, time required for NGT insertion, and complication among each anesthesiologists.
In all patient groups, a 14 French gauge (FG), 125 cm NGT with lead was used.
The length of NGT necessary to reach the stomach was assessed before insertion and measured by placing the tip of the NGT on the patient’s xiphoid process and extending it to the tip of his/her nose and over the earlobe. Immediately before insertion, KY jelly was applied. In the neck flexion with lateral neck pressure group (Group F), a lubricated NGT was inserted through the selected nostril to a depth of 10 cm. Lateral neck pressure was applied at the same side as that of the selected nostril with the neck flexed and the NGT was advanced. In the GlideScope™ visualization group, the blade of the GlideScope™ visualization was inserted into the patients’ mouths, the tracheal tube and the tongue were lifted to provide the physician with the best view of the pharyngeal area.
In case of failure of insertion in the first attempt second attempt was made by that same technique.
If both attempts were unsuccessful, then the technique was considered as a 'procedure failure'. The NGT was reinserted switching over these two techniques. If that too failed the NGT was introduced under direct vision by Macintosh laryngoscope and was manipulated using Magill’s forceps. (refer to Fig. 1 for the study flow chart).
Position was confirmed by epigastric auscultation of a gargling sound when 10 mL of air was insufflated via the NGT and no coiled/kinked NGT in the oral cavity.
The time taken for insertion was calculated from the initiation of NGT insertion through nostril until confirmation of its successful placement into the stomach. A general anesthesia assistant measured the time taken using stop-watch.
The occurrence of complications such as bleeding, kinking and coiling during the procedure was noted. The rate of successful NGT insertion and the duration needed for successful insertion on the first and second attempt was compared between the 2 groups.
The primary outcome of this study was the overall success rate which was defined as succeeded within two attempts. Secondary outcomes were failure rate, and the duration of insertion time in both groups. The complications of NGT passage, such as bleeding, kinking and coiling.
The sample size was calculated by two independent proportions, two-tailed test, formula; based on previous data [4, 12]. Those authors reported that first-attempt success rate was 85% in GlideScope™ visualization group and 56.7% in head flexion and lateral neck pressure group. Alpha error was 0.05, whilst ß error was 0.2. The calculated sample size per group was 38, after adding 10% dropout the final sample size was 43 subjects per group. Performed by R language, version 3.3.3 Categorical variables were compared by Chi-square or Fisher’s exact test, whilst continuous variables were assessed by Shaparo-Wilk normality test before compared by t-test or Wilcoxon rank-sum test. The p-value of less than 0.05 was considered statistically significant.