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      The CobraPLA™ During Anesthesia with Controlled Ventilation: A Clinical Trial of Efficacy

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          Abstract

          The CobraPLA™ (CPLA) is a relatively new supraglottic airway device that has not been sufficiently investigated. Here, we performed a prospective observational study to evaluate the efficacy of the CPLA during controlled ventilation. In 50 anesthetized and paralyzed patients undergoing elective surgery a CPLA was inserted and inflated to an intracuff pressure of 60 cm H 2O. The success rate of insertion upon the first attempt was 82% (41/50), with a mean insertion time of 16.3 ± 4.5 seconds. The adequacy of ventilation was assessed by observing the end tidal CO 2 waveform, movement of the chest wall, peak airway pressure (13.5 cm H 2O), and leak fraction (4%). We documented the airway sealing pressure (22.5 cm H 2O) and noted that the the site of gas leaks at that pressure were either at the neck (52%), the abdomen (46%), or both (2%). In 44 (88%) patients, the vocal cords were visible in the fiberoptic view through the CPLA. There was no gastric insufflation during the anesthesia. Respiratory and hemodynamic parameters remained stable during CPLA insertion. Postoperative blood staining of CPLA was minimal, occurring in 22% (11/50) of patients. Mild and moderate throat soreness was reported in 44% (22/50) and 4% (2/50) of patients, respectively. Lastly, mild dysphonia was observed in 6% (3/50) of patients and mild dysphagia in 10% (5/50) of patients. Our results indicated that the CPLA is both easy to place and allows adequate ventilation during controlled ventilation.

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          Most cited references 22

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          A proposed fiber-optic scoring system to standardize the assessment of laryngeal mask airway position.

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            Nitrous oxide increases endotracheal cuff pressure and the incidence of tracheal lesions in anesthetized patients.

            The pressure in air-filled endotracheal cuffs increases steadily throughout general anesthesia with nitrous oxide (N2O). High cuff pressures can be responsible for local ischemia, which may induce tracheal mucosal injury. In this study, cuff pressure was monitored in anesthetized patients, and postanesthesia endotracheal lesions were assessed by endoscopy. Sixty-five patients undergoing general anesthesia with tracheal intubation >1 h in duration were randomized into two groups. The endotracheal tube cuff was inflated to 30-40 cm H2O with air in Group 1 (n = 33) and with a gas mixture (N2O 50% in oxygen) in Group 2 (n = 32). At the time of tracheal extubation, a fiberoptic examination via the endotracheal tube was performed by an independent observer. Aspects of trachea at the level of cuff contact area were scored as 0 = normal, 1 = mucosal erythema or edema, 2 = mucosal erosion or hemorrhage, 3 = mucosal erosion or hemorrhage on both anterior and posterior tracheal walls. Cuff pressure increased throughout the procedure (P<0.01) in Group 1 and remained stable in Group 2. In Group 1, tracheal lesions in the area of the cuff were more frequent than they were in Group 2 (79% vs. 37%; P<0.001). Tracheal injury was correlated to cuff pressure (r = 0.62, P<0.001). No postoperative respiratory complication was observed in any patient. In patients anesthetized with N2O, the inflation of the tracheal tube cuff with a gas mixture of the same composition as the inhaled mixture can prevent excessive cuff pressure and reduce the incidence of tracheal injury. In patients anesthetized with nitrous oxide, the inflation of the tracheal tube cuff with a gas mixture of the same composition as the inhaled mixture can prevent excessive cuff pressure and reduce the incidence of tracheal injury.
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              The laryngeal mask airway and positive-pressure ventilation.

              The utility of the laryngeal mask airway during positive-pressure ventilation has yet to be determined. Our study was designed to assess whether significant leaks occurred with positive-pressure ventilation and if leaks were associated with gastroesophageal insufflation. Forty-eight patients undergoing elective surgery were studied. After induction of anesthesia and paralysis, controlled ventilation was used with four different peak pressure settings in each patient (15, 20, 25, and 30 cmH2O). The order of ventilator pressure settings was assigned from a randomized block schedule. Data collected included inspiratory and expiratory volumes, qualitative assessments of gastroesophageal insufflation, and leak at the neck. After data collection during laryngeal mask use, the anesthesiologist intubated the trachea and measurements were repeated for tracheal tube ventilation. Leak was calculated by subtracting the expiratory from the inspiratory volume and expressed as a fraction of the inspiratory volume. Ventilation with the laryngeal mask airway was adequate at all ventilation pressures and comparable with tracheal tube ventilation. Leak fraction (mean +/- SD) at 15, 20, 25, and 30 cmH2O for laryngeal mask ventilation were 0.13 +/- 0.15, 0.21 +/- 0.18, 0.25 +/- 0.16 and 0.27 +/- 0.17, respectively, and 0.03 +/- 0.03, 0.05 +/- 0.03, 0.05 +/- 0.03 and 0.04 +/- 0.03, respectively, for tracheal tube ventilation. Leak fractions for ventilation with the laryngeal mask were consistently greater than those measured for tracheal tube ventilation at similar ventilation pressures. Leak fraction with laryngeal mask ventilation increased with increasing airway pressures, whereas leak with tracheal tube ventilation remained unchanged. The frequency of gastroesophageal insufflation ranged from 2.1% at a ventilation pressure of 15 cmH2O to 35.4% at 30 cmH2O. Ventilation using the laryngeal mask appears to be adequate if airway resistance and pulmonary compliance are normal. Gastroesophageal insufflation of air will become a problem in the presence increased ventilation pressure.
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                Author and article information

                Journal
                Yonsei Med J
                YMJ
                Yonsei Medical Journal
                Yonsei University College of Medicine
                0513-5796
                1976-2437
                31 December 2006
                31 December 2006
                : 47
                : 6
                : 799-804
                Affiliations
                Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Korea.
                Author notes
                Reprint address: requests to Dr. Jong Seok Lee, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, 146-92 Dogok-dong, Kangnam-gu, Seoul 135-720, Korea. Tel: 82-2-2019-3520, 3524, Fax: 82-2-3463-0940, jonglee@ 123456yumc.yonsei.ac.kr
                Article
                10.3349/ymj.2006.47.6.799
                2687819
                17191308
                Copyright © 2006 The Yonsei University College of Medicine

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                Categories
                Original Article

                Medicine

                supraglottic device (cobrapla™), leak pressure, airway, oxygenation, ventilation

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