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Anaesthesia, 2010, 65, pages 1114–1118 doi:10.1111/j.1365-2044.2010.06510.x ..................................................................................................................................................................................................................... ORIGINAL ARTICLE Gastro-Laryngeal Tube for endoscopic retrograde cholangiopancreatography: a preliminary report* L. A. Gaitini,1 A. Lavi,2 E. Stermer,3 P. Charco Mora,4 L. M. Pott5 and S. J. Vaida5 1 Clinical Associate Professor, Department of Anaesthesia, 2 Clinical Associate Professor, Department of Gastroenterology, 3 Senior Lecturer, Consultant Gastroenterologist, Bnai-Zion Medical Center, Haifa, Israel 4 Consultant Anesthetist, Department of Anaesthesia, Hospital Son Dureta, Palma de Mallorca, Spain 5 Associate Professor, Department of Anaesthesia, Penn State Milton S. Hershey Medical Center, Hershey, PA, USA Summary The Gastro-Laryngeal Tube is a modification of the Laryngeal Tube that provides a dedicated channel for the insertion of a gastroscope. In this study of 30 patients undergoing general anaesthesia for endoscopic retrograde cholangiopancreatography, we evaluated both the effectiveness of airway management with a Gastro Laryngeal Tube and the feasibility of performing it using the endoscopic channel. The Gastro Laryngeal Tube was inserted successfully in all patients, in 27 patients at the first attempt. The mean (SD) time to achieve an effective airway was 26 (6) s. Mean (SD) inspiratory and expiratory tidal volumes were 336 (57) ml and 312 (72) ml, respectively, and oropharyngeal leak pressure was 33.7 (2) cmH2O. These data suggest that the Gastro Laryngeal Tube is an effective and secure device for airway management and for use during performance of endoscopic retrograde cholangiopancreatography. . ...................................................................................................... Correspondence to: L. A. Gaitini Email: [email protected] *Presented in part at Euroanesthesia, Milan, Italy, June 2009. Accepted: 18 August 2010 Endoscopic retrograde cholangiopancreatography (ERCP) is usually performed in the prone position under moderate or deep sedation, or under general anaesthesia [1]. Conscious sedation for ERCP has been associated with cardio respiratory complications, particularly drug-induced respiratory depression and airway obstruction [2–5]. General anaesthesia has the advantage of airway protection, a lower ERCP failure rate [6] and lower complication rates associated with therapeutic ERCP interventions [2, 7]. When general anaesthesia is used, airway protection can be achieved with a tracheal tube or a laryngeal mask airway [8]. However, tracheal intubation usually requires the use of neuromuscular blocking drugs and has been associated with a longer extubation time compared with the laryngeal mask airway [8]. The Gastro Laryngeal Tube (VBM Medizintechnik GmbH, Sulz, Germany; Fig. 1) is a modification of the Laryngeal Tube which provides a dedicated channel for the insertion of a gastroscope, while acting as a supra1114 glottic airway for ventilation. It has two high-volume, low-pressure interconnected cuffs: a proximal pharyngeal cuff that seals the oropharynx and nasopharynx and helps to stabilise the tube; and a distal oesophageal cuff that is designed to seal the oesophagus and reduce the risk of pulmonary aspiration. Both cuffs are inflated to an intracuff pressure of approximately 60 cmH2O through a single inflation valve attached to the pilot balloon. The Gastro Laryngeal Tube is constructed of latex-free medical grade silicone and has a built-in bite block to protect the endoscope. The endoscopic channel has an internal diameter of 16 mm and enables the insertion and use of a gastrointestinal endoscope with a maximum external diameter of 13.8 mm. It is coated with a special polymer to minimise friction caused by the insertion and movement of the endoscope. The Gastro Laryngeal Tube is manufactured only in one size and can be used for patients with a body length > 155 cm. The purpose of our prospective observational study was to make a preliminary assessment the safety and 2010 The Authors Anaesthesia 2010 The Association of Anaesthetists of Great Britain and Ireland Æ Anaesthesia, 2010, 65, pages 1114–1118 L. A. Gaitini et al. Gastro-Laryngeal tube and endoscopic retrograde cholangiopancreatography . .................................................................................................................................................................................................................... Figure 1 A Gastro-Laryngeal Tube. effectiveness of this device for airway management in patients undergoing general anaesthesia for ERCP, and assess the feasibility of using its endoscopic channel for the performance of the ERCP. Method The study was approved by the Bnai-Zion Medical Center Human Ethics Committee and written informed consent was obtained from all patients. Thirty patients, aged between 18–75 years and with an ASA physical status 1 to 3, scheduled for ERCP, were enrolled. Only patients with normal airways were included into the study. Patients were excluded if their modified Mallampati classification was 3 or 4, the thyromental distance was < 3 fingers, the intercisor distance was < 2 fingers, the head and neck mobility was limited, or if gross morphological abnormalities of the head and neck were present. Further exclusion criteria were: oesophageal disease; active gastro-oesophageal reflux disease; pregnancy; restrictive lung disease; or > 20% deviation from the ideal body weight. Two consultant anaesthetists experienced in the use of the Laryngeal Tube inserted the Gastro Laryngeal Tube and two consultant gastroenterologists performed the ERCP. General anaesthesia was induced with fentanyl up to 3 lg.kg)1 and propofol 2–3 mg.kg)1, and maintained with a continuous infusion of propofol 100 lg.kg)1.min)1, without neuromuscular blocking drugs. The patients were allowed to breathe spontaneously and manual ventilation assistance was only provided if necessary, for short periods after induction of general anaesthesia. The Gastro Laryngeal Tube was inserted with the patient in the 2010 The Authors Anaesthesia 2010 The Association of Anaesthetists of Great Britain and Ireland supine position and the head in the neutral or sniffing position, keeping it in the midline of the mouth with the distal part against the hard palate. Once the hypopharynx was reached, the left index finger was used to direct the distal part into the oesophagus. This Gastro Laryngeal Tube insertion technique is based on that of the Laryngeal Tube or Laryngeal Tube Suction insertion method recommended by the manufacturer [9]. Airway manoeuvres, graded as minor (adjusting the head ⁄ neck position, lateral movements of the device) and major (re-insertion of the device), were applied if the Gastro Laryngeal Tube was not successfully inserted. Both balloons of the Gastro Laryngeal Tube were sequentially inflated with air using a manometer (Cuff Pressure Gauge; VBM Medizintechnik GmbH) until intra-balloon pressure reached 80 cmH2O, and then the deflate valve was pressed to adjust the pressure to 60 cmH2O. Proper positioning of the Gastro Laryngeal Tube was confirmed by bilateral chest movement and auscultation, absence of gastric insufflation and by the presence of a normal capnogram. The airway was judged to be effective and adequate if the operator could achieve at least 8–10 ml.kg)1 of expired volume during gentle manual ventilation, as well as a normal capnogram trace and a normal flow-volume loop. Two insertion attempts were allowed and the number of insertion attempts was recorded. The insertion time was noted from the removal of the facemask to attachment of the device to the breathing system and the appearance of a normal capnogram trace. After the demonstration of successful placement, the patients were positioned prone with the head in the right lateral position, and proper position of the Gastro 1115 Æ L. A. Gaitini et al. Gastro-Laryngeal tube and endoscopic retrograde cholangiopancreatography Anaesthesia, 2010, 65, pages 1114–1118 . .................................................................................................................................................................................................................... Laryngeal Tube was reassessed. Arterial oxygen saturation, expired carbon dioxide, and inspired and expired tidal volumes were recorded using an AS ⁄ 3 Anaesthesia Delivery Unit (Datex-Ohmeda, Helsinki, Finland) at 5-min intervals. Oropharyngeal leak pressure was determined by closing the expiratory valve of the circle system at a fixed gas flow of 3 l.min)1 and noting the airway pressure (maximum allowed was 40 cmH2O) at which the circuit pressure stabilised [10]. The ERCP was performed with a 11-mm duodenoscope (Pentax ED-3480 Tokyo, Japan). The Gastro Laryngeal Tube was manually stabilised during insertion of the endoscope in order to prevent displacement. Upper airway trauma was assessed by checking for the presence of blood on the Gastro Laryngeal Tube after removal. Patients were questioned postoperatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the post-anaesthesia care unit and again 24 h after surgery. The patients were asked non-leading questions. Symptoms were graded by the patients as mild, moderate or severe. Clinically unacceptable ventilation, a peak airway pressure exceeding 40 cmH2O, or an oxygen saturation below 90% resulted in immediate termination of the study. Further anaesthetic management was at the discretion of the anaesthetist. Table 1 Patients’ characteristics and indications for endoscopic retrograde cholangiopancreatography. Values are mean (SD) or number. Characteristics Age; years Weight; kg Height; cm Body mass index; kg.m2 Sex; M:F ASA grade; 1/2/3 69.4 (4) 72.53 (4) 168.4 (7) 25.6 (5) 17 ⁄ 13 0 ⁄ 21 ⁄ 9 Indications Choledocholithiasis Cholelithiasis Obstructive jaundice Stent replacement Stent removal Suspected common bile duct stones Common bile duct stenosis Abnormal liver function test 5 5 8 3 2 3 2 2 Symptoms disappeared in all patients within 24 h without any intervention. The ERCP was performed successfully in all patients though the endoscopic channel of the Gastro Laryngeal Tube, with a mean (SD) duration of 43 (11) min. Results Patients’ characteristics and indications for endoscopy are presented in Table 1. None of the 30 patients recruited into the study were excluded. The Gastro Laryngeal Tube was inserted successfully in all patients, in 27 at the first attempt and in three at the second attempt. The mean (SD) time to achieve an effective airway was 26 (6) s. Oxygenation and ventilation were successful in all patients with a mean (SD) arterial oxygen saturation of 98.6 (0.6) % and expired carbon dioxide of 5.7 (1) kPa. The mean (SD) inspiratory and expiratory tidal volumes were 336 (57) and 312 (72) ml, respectively and oropharyngeal leak pressure was 33.7 (2) cmH2O. Minor airway interventions were necessary in nine patients (adjusting head ⁄ neck position in four patients and lateral movements of the device in five patients). Major airway interventions (re-insertion of the device) were necessary in three patients. Bloodstains were present on the Gastro Laryngeal Tube after its removal in three cases (insertion having been successful on the first attempt in two cases and on the second attempt in one case). Four patients complained of sore throat, one patient complained of dysphagia, and one complained of dysphonia in the post-anaesthesia care unit. These symptoms were all classified as mild, with the exception of one patient who complained of a moderate sore throat. 1116 Discussion This study describes the successful use of the Gastro Laryngeal Tube for ERCP. The Gastro Laryngeal Tube was successfully inserted, and allowed oxygenation and ventilation as well as successful performance of diagnostic and therapeutic ERCP. Except for short periods of apnoea immediately after induction of general anaesthesia, all patients were spontaneously breathing throughout the procedure. The anaesthetic management for ERCP differs from institution to institution, and ranges from conscious and deep sedation to general anaesthesia with tracheal intubation [2, 6]. Propofol, midazolam and fentanyl are safely used as the preferred sedative drugs at many institutions [1]; however the risk of oversedation, and respiratory or cardiopulmonary complications is always present. Qadeer et al. [11], in a meta-analysis of the current literature, showed that the use of propofol for sedation in ERCP had a similar risk of complications when compared with midazolam, pethidine, and ⁄ or fentanyl. Recently, the ASA House of Delegates approved a statement on endoscopic sedation that recommended monitoring exhaled carbon dioxide during laparoscopic endoscopy procedures in which sedation is provided with propofol alone, or in combination with opioids and a 2010 The Authors Anaesthesia 2010 The Association of Anaesthetists of Great Britain and Ireland Æ Anaesthesia, 2010, 65, pages 1114–1118 L. A. Gaitini et al. Gastro-Laryngeal tube and endoscopic retrograde cholangiopancreatography . .................................................................................................................................................................................................................... benzodiazepine. In addition, special attention to airway management was recommended, especially during ERCP in the prone position [12]. Conscious or deep sedation may be inadequate for successful completion of the ERCP, with lack of airway control causing inadequate oxygenation and ventilation. A high incidence of hypoxaemia has been reported during endoscopies performed under sedation [13–15]. Supplemental administration of oxygen is usually sufficient to reverse hypoxaemia; however, patients requiring deeper levels of sedation may lose airway patency [8]. In addition, a decrease in arterial oxygen saturation below 90% has been associated with an increased risk of post-ERCP pancreatitis [15]. A further risk to patients having sedation or conscious sedation is aspiration of gastric contents as a result of an unprotected airway. This potential complication requires close attention to the patients’ airways at all times during the procedure. For these reasons, some anaesthetists prefer general anaesthesia with a tracheal tube. The potential benefit of using a supraglottic airway device for airway protection during ERCP is the maintenance of a patent airway whilst avoiding laryngoscopy and tracheal intubation with their consequent undesirable haemodynamic responses [16]. We are aware of only one article describing the successful use of the laryngeal mask airway to secure the airway during ERCP [8]. In this study, the laryngeal mask airway was placed and removed in the prone position, and was associated with a shorter recovery time compared to the tracheal tube [8]. In our study, the Gastro Laryngeal Tube was placed and removed with the patient in the supine position and the patient was safely turned into the prone position with the device in situ. Oxygenation and ventilation were normal during all the procedures, showing that the Gastro Laryngeal Tube is an effective device during spontaneous ventilation in the prone position. The incidences of bloodstains, sore throat, dysphagia and dysphonia were similar to those of previously published data describing the use of the Laryngeal Tube and Laryngeal Tube Suction [17, 18]. These side-effects are probably caused by either the insertion technique used or the pressure exerted by the cuffs on the surrounding soft tissues. A limitation of this study is that the two anaesthetists who inserted the Gastro Laryngeal Tube had significant prior experience with the Laryngeal Tube and Laryngeal Tube Suction, which make well not be the case for other anaesthetists. Acknowledgments The authors thank VBM Medizintechnik GmbH, Sulz, Germany for providing the Gastro Laryngeal Tubes to 2010 The Authors Anaesthesia 2010 The Association of Anaesthetists of Great Britain and Ireland perform this study. 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