Materials and Methods

 

 

Legal and Ethical Considerations. The study was approved by the Institutional Review Board. Informed patient consent was obtained for the planned strategy of airway management (AM) and the anonymous use of patient data for scientific purposes.

 

Patient Selection. The study was performed at a community hospital with a reference center for the management of thyroid diseases; the institutional department of general surgery performs more than 1200 thyroid surgical procedures a year. Adult patients with American Society of Anesthesiologists physical status classification 1, 2, or 3 requiring orotracheal intubation for elective thyroid surgery were investigated when the GlideScope Video Laryngoscope (GVL) was available. Patients with gastroesophageal reflux disease and those with difficult face-mask ventilation experienced during induction of general anesthesia were excluded from the study. Patients with previously experienced difficult conventional tracheal intubation, anatomic features predictive for difficult conventional laryngoscopy and tracheal intubation [such as limited mouth opening (but not less than 20 mm), restrictions in forward movement of the jaw, reduced thyromental distance, and/or limitations in head and neck movement], and/or obesity were given preferential enrollment into the study. Therefore, this clinical investigation represents data of a prospective, but non-consecutive observational study.

 

Participating Operators. The operators (voluntary staff anesthetists, anesthesia residents, and qualified anesthesia nurses could participate in the study) had no experiences with GVL-assisted laryngoscopy and tracheal intubation. They first received formal hands-on training on an airway model (Laerdal Airway Management Trainer, Laerdal, Stavanger, Norway) for acquisition of sufficient skills in handling with the GVL and articulating the tracheal tube (TT) using the Schroeder directional tracheal tube stylet (DS; Parker Flex-It Stylet, Parker Medical, Englewood, Colorado, United States) for passage through the laryngeal aperture, and were then instructed during the first 10 applications on patients (the number for obtaining acceptable clinical performance and competence estimated by the instructor). The study design provided GVL-assisted laryngoscopy and tracheal intubation attempts on a maximum of 25 patients.  

 

Experienced Instructor. The instructor (the corresponding author of this clinical investigation) first searched the literature (main findings: 2, 3, 6, 7) and had personal contact with an early user of the GVL (Richard M. Cooper, Toronto, Ontario, Canada) at a meeting and workshop for AM in March 2005. He then evaluated and trained GVL-assisted laryngoscopy and tracheal intubation on an airway model (Laerdal Airway Management Trainer), before performing the technique on selected patients. After acquiring experience with the GVL and performing an evaluation process, testing the efficacy and safety of the GVL using conventional malleable tracheal tube stylets and the DS in easy and later in difficult tracheal intubation situations (including more than 50 patients), he initiated the stepwise introduction of the GVL (using only the DS) into clinical practice by formal instruction of novice users.

                   

Anesthetic Technique. Patient monitoring and anesthetic care were provided by the S/5 Anesthesia Delivery Unit (Datex-Ohmeda, Instrumentarium Corporation, Helsinki, Finland). Glycopyrrolate 0.2 to 0.4 mg was given 3 min before induction of anesthesia. Following preoxygenation, general anesthesia was induced with 2.5 to 3.5 mg.kg^-1 propofol supplemented by 1.5 to 3.0 µg.kg^-1 fentanyl. After confirmation of effective face-mask ventilation with oxygen, muscle relaxation was achieved using 0.6 mg.kg^-1 rocuronium. During airway management (AM), intermittent boluses of propofol were occasionally given at the discretion of the instructor for maintaining an adequate depth of anesthesia.

 

Conventional Laryngoscopy. After complete neuromuscular blockade [judged by neuromuscular transmission (S/5 Neuromuscular Transmission Module and Mechanosensor, with the electrodes placed over the ulnar nerve using the train-of-four mode)], conventional laryngoscopic view grading (CLV) was performed using direct laryngoscopy with a standard Macintosh laryngoscope for fiberoptic battery handles (Karl Storz Endoscopy, Tuttlingen, Germany; blade sizes 3 and 4 in small and large adults, respectively). The depth of blade insertion was determined by the vallecula; gentle lifting force on the blade was applied and the laryngeal view was evaluated without external laryngeal manipulation. Positioning of the patient regarding elevation of the head and extension of the neck [particularly using the ramped head-elevated laryngoscopy position in obese patients (1)] was at the discretion of the operator when staff anesthetist, otherwise at the discretion of the instructor.

 

Conventional Laryngoscopic View Grading. The 5-grade modification of the original classification of laryngoscopic views by Cormack and Lehane was used for CLV (8): grade 1, visualization of the entire laryngeal aperture; grade 2, visualization of just the posterior portion of the laryngeal aperture; grade 3, visualization of only the arytenoids; grade 4, visualization of only the epiglottis; and grade 5, visualization of just the soft palate. Laryngoscopy and tracheal intubation with the GVL were then attempted after a short period of face-mask ventilation with oxygen.

 

Description of the Video Laryngoscpe. The GLV is made from medical-grade plastic material and similar to the Macintosh laryngoscope, but the blade has a pronounced 60-degree upward angulation. The maximum thickness of the Standard Adult GVL blade, the model used in this study, is 18 mm. A high-resolution, fog-resistant (mechanism: immediate warming-up to body temperature) video camera is situated on the inferior aspect of the blade at its inflection point. The view obtained is oriented anteriorly and the video camera is sufficiently remote from the laryngeal aperture to provide a wide visual field. Two light emitting diodes adjacent to the video camera provide adjustable illumination. A power cord/video cable, emerging from the handle, attaches to a dedicated, light-weight liquid crystal display monitor (mounted on a mobile stand) where the resulting color image is displayed.

 

Video Laryngoscopy. The GVL was inserted in the midline into the oral cavity; early identification of the uvula centered on the monitor was used as the first landmark to ensure that the blade was in the midline and correctly orientated. The blade was then slided around the tongue into the posterior pharynx; optimum depth of insertion was determined by the vallecula. The blade was slightly elevated against the dorsal face of the tongue with minimum upward pressure for indirectly lifting the epiglottis. 

 

Video Laryngoscopic View Grading. Positioning of the patient (as selected for CLV) remained unchanged. The laryngeal views obtained with the GVL were evaluated with the same 5-grade classification as used for CLV using gentle lifting force without external laryngeal manipulation.

   

Description of the Directional Tracheal Tube Stylet. The DS is a single-use device available in two sizes; for the study, the Flex 7580 [dedicated for tracheal tubes (TTs) with inner diameters of 7.5 and 8.0 mm] was used. The DS consists of two polyethylene members joined at their distal ends and a proximal thumb button and flange. Activation of the thumb button against the flange induces an articulating action in the DS and a variable curvature in the surrounding TT, particularly in the distal area. 

 

Tracheal Intubation Technique. GVL-assisted tracheal intubation was attempted when laryngeal structures were visible. The usual level of the operating table was lowered to ease manipulation of the styletted TT. Standard TTs (Lo-Contour Murphy, Mallinckrodt Medical, Athlone, Ireland) with inner diameters of 7.5 and 8.0 mm were used in small and large adults, respectively. The selected TT was fitted with the DS (after testing for cuff leakage) and preferably introduced midline beneath the phalange of the GVL blade; occasionally (in patients with limited mouth opening and/or restricted pharyngeal space), the TT was introduced from the right lateral side. The thumb action on the DS allowed to remotely adjust the curvature of the TT during the tracheal intubation process. After advancing the tip of the TT through the laryngeal aperture, the DS was withdrawn by about 4 cm; this usually straightens the tip of the TT and eases advancement of the tube. When further advancement of the TT was impeded (by impinging on the anterior wall of the thyroid cartilage or the anterior trachea), the DS was completely withdrawn and the TT was rotated 90 degree or more to the right to facilitate passage into a midtracheal position. After visual confirmation of correct placement, the TT was secured at its proximal end and the GVL was removed by rotating the unit forward back and gently lifting it out of the oral cavity. 

 

Constructive Feedback during Instruction. Under video laryngoscopic control on the monitor of the GVL system, the instructor also observed the entire laryngoscopy and tracheal intubation process and could advice and correct the operator in handling the GVL and manipulating and advancing the TT, when necessary.

 

Procedure after Failed Tracheal Intubation. When tracheal intubation failed after two separate attempts (duration more than 120 seconds and/or desaturation with oxygen saturations less than 95 percent), further AM (and the tracheal intubation technique applied) was at the discretion of the operator when staff anesthetist, otherwise at the discretion of the instructor. Between the tracheal intubation attempts, the patients received face-mask ventilation with oxygen to ensure adequate oxygenation.

 

Hygienic Reprocessing of the Video Laryngoscope. The GVL was disinfected immediately after each use on patients using cold sterilization and detergent solutions approved by the hygienic committee of our institution. The protective cap was placed over the connector cable port on the handle before immersion to prevent corrosion of the contacts.    

 

Severe Complaints and Injuries Associated with Airway Management. Severe complaints and injuries to oropharyngeal, laryngeal, and/or tracheal structures associated with AM were evaluated by the instructor at the postanesthesia care unit and during the postanesthesia visit on the first postoperative day at the normal ward.   

 

Independent Observer. The instructor was also independent observer during the entire study. He documented the conventional laryngoscopic views (rated by the operator) and the video-laryngoscopic views (rated by himself) obtained; furthermore, he documented minor problems and difficulties and failures during AM, the procedure(s) applied after failed tracheal intubation, and severe complaints and injuries associated with AM. 

 

Statistics. Statistical analysis was performed using a statistical software program (SAS, version 8.20, SAS Institute Incorporated, Cary, North Carolina, United States). After passing normality test, one way analysis of variance was performed; multiple comparison using the Tukey test followed if the one way analysis of variance showed significance. Results were considered significant at p-values less than 0.05.

 

 

Results