BackgroundA variety of videolaryngoscopes with angulated blade have been recently introduced into clinical practice. They provide an indirect view of the glottic structures in normal and challenging clinical settings. Despite the very good visualization of the laryngeal structures by these devices, the insertion and advancement of the endotracheal tube may be prolonged and occasionally fail as it does not conform to the enhanced angulation of the blade. To overcome this handicap, it is recommended to use a pre-shaped, styleted tracheal tube during intubation. Unfortunately, these malleable rigid stylets permit only a fixed shape to the advancing endotracheal tube. This may necessitate withdrawal of endotracheal tube-stylet assembly for reshaping, before undertaking a new attempt. This may cause soft tissue injury and hemodynamic disturbance.This single-blinded randomized clinical trial aims to overcome these handicaps using a novel method of dynamically changing the shape of the advancing endotracheal tube by Truflex™ articulating stylet as per need during D-blade C-Mac™ videolaryngoscopy.MethodsOne hundred and fifty four patients between 18 and 60 years of age belonging to either sex undergoing tracheal intubation under uniform general anesthetic technique will be randomly divided into Portex™ malleable stylet group and Truflex™ articulating stylet group. The primary efficacy variable of success/failure between the two groups will be analyzed using the chi square test. For comparison of intubation times and the Intubation Difficulty Score, ANOVA will be used. Primary efficacy endpoint results will be successful or failed tracheal intubation in the first attempt, total intubation time and the intubation difficulty score. Secondary efficacy endpoints will be overall user satisfaction graded from 1 to 10 (1 = very poor, 10 = excellent), Cormack and Lehane’s grading, glotticoscopy time and ETT negotiation time and total number of intubation attempts. Result of safety endpoints will include dental and airway trauma, hemodynamic disturbances, arrhythmias or cardiac arrest.Trial registrationCurrent Controlled Trials ISRCTN57679531; Date of registration 12/02/2013
Background:Tracheal intubation using Storz’s C-Mac D-bladeTM videolaryngoscope is associated with difficult negotiation of the tracheal tube into the glottis due to steep angulation of its blade.Objectives:In this study, we hypothesized that TruflexTM articulating stylet with its ability to dynamically tailor the ETT shape to patients’ oropharyngeal anatomy would be better suited to the D-blade angulation and ease tracheal intubation compared to PortexTM intubation stylet.Patients and Methods:Following approval by the Ethical Issues Committee and informed consent, 218 ASA I and II patients of either sex were enrolled in this interventional, single-blind, randomized controlled trial. Tracheal intubation was performed following a uniform general anesthetic technique using the Storz’s C-Mac D-bladeTM videolaryngoscope aided by either TruflexTM articulating stylet or the PortexTM intubation stylet by an experienced anesthesiologist. The outcome measures included success or failure to intubate in the first attempt, total intubation time, hemodynamic disturbances, trauma if any and user satisfaction.Results:The number of patients in whom intubation was successful in the first attempt was significantly higher by using Truflex™ articulating stylet (99.1%) compared to PortexTM intubation stylet (90.0%; P-Value = 0.003). User satisfaction grade was significantly better while using TruflexTM articulating stylet (8.5 ± 0.88) compared to the PortexTM intubation stylet (8.23 ± 0.99; P-Value = 0.035). We did not observe any significant difference in total intubation time, hemodynamic disturbances or trauma.Conclusions:Storz’s C-Mac D-bladeTM videolaryngoscope provides grade I Cormack and Lehane’s glottic view in 99.1% patients. First attempt successful tracheal intubation and user satisfaction significantly improved by TruflexTM articulating stylet compared to the PortexTM intubation stylet.
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