ORIGINAL ARTICLE
Gastric Distension With SLIPA Versus LMA ProSeal During Laparoscopic Cholecystectomy: A Randomized Trial Su Man Cha, MD,* Sihyun Park, RN, MSN,w Hyun Kang, MD, PhD,zy Chong Wha Baek, MD, PhD,z Yong Hun Jung, MD, PhD,z Young Joo Cha, MD, PhD,y8 and Junyong In, MD, PhDz
Background: We compared the quantitative clinical performances of the streamlined liner of the pharynx airway (SLIPA) and the ProSeal laryngeal mask airway (LMA ProSeal) regarding intensity of gastric distension in patients undergoing laparoscopic cholecystectomy. Methods: A total of 124 anesthetized, paralyzed patients (ASA 1 to 2; aged, 18 to 80 y) were randomly allocated for airway management with the SLIPA or LMA ProSeal. After induction of general anesthesia using total intravenous anesthesia and rocuronium, the intensity of gastric distension was accessed twice by 2 raters, respectively. We also compared the fiberoptic bronchoscopic view of the glottis, the severity of blood stain, and postoperative sore throat. Results: There were no statistically significant differences between groups for each gastric size. The change of gastric size within the SLIPA group was not statistically significant for both raters. Change within the LMA ProSeal group was significant in rater 2 (P = 0.045) and marginally significant for rater 1 (P = 0.056). Anatomic fit, complications during emergence, and the severity of blood stain and postoperative sore throat were similar in both groups. Conclusions: SLIPA is as efficacious as LMA ProSeal for use in patients without severe complications who are undergoing laparoscopic cholecystectomy. Key Words: gastric distension, laparoscopic cholecystectomy, laryngeal mask airway, SLIPA
(Surg Laparosc Endosc Percutan Tech 2014;24:216–220)
T
he streamlined liner of the pharynx airway (SLIPA; SLIPA Medical Ltd, London, UK) is becoming recognized as a safe and effective supraglottic airway for airway management during surgery.1–10
Received for publication January 16, 2013; accepted March 4, 2013. From the *Department of Anesthesiology and Pain Medicine, College of Medicine, Ajou University, Suwon; zDepartment of Anesthesiology and Pain Medicine; 8Department of Laboratory Medicine; yMedical Device Clinical Trials Center, College of Medicine, Chung-Ang University, Seoul; zDepartment of Anesthesiology and Pain Medicine, Ilsan Hospital, Dongguk University Medical Center, Goyang, Republic of Korea; and wSchool of Nursing, University of Washington, Seattle, WA. Supported by a grant of the Korea Healthcare Technology R&D Project, Ministry of Health and Welfare, Republic of Korea (A100054). The authors declare no conflicts of interest. Reprints: Hyun Kang, MD, PhD, Department of Anesthesiology and Pain Medicine, College of Medicine, Chung-Ang University, 224-1 Heukseok-dong, Dongjak-gu, Seoul 156-755, Korea (e-mail: [email protected]). Copyright r 2014 by Lippincott Williams & Wilkins
216 | www.surgical-laparoscopy.com
In laparoscopic cholecystectomy, because stomach and gallbladder are anatomically adjacent, gastric distension can obstruct the operator’s field of vision and interfere with surgical manipulation, which makes it imperative to lower the incidence and intensity of gastric distension. The effectiveness of supraglottic airway during laparoscopic cholecystectomy has been studied in terms of gastric insufflations and distension.11–13 Such studies reported that the classical laryngeal mask airway (LMA Classic) and the ProSeal laryngeal mask airway (LMA ProSeal; Laryngeal Mask Company, Henley-on-Thames, UK) were comparable to an endotracheal tube regarding the change in gastric distension during laparoscopic cholecystectomy. However, to the best of our knowledge, there is no study concerning the use of SLIPA in laparoscopic cholecystectomy. SLIPA was compared with LMA ProSeal on gastric distension only in lower abdominal laparoscopic surgery6,8 and ill-defined surgeries (requiring supine position during operation).5 In addition, although SLIPA offered the advantage of less perilaryngeal gas leakage and a similar incidence of gastric insufflations compared with LMA ProSeal in previous studies,5,6,8 the results did not include quantitative measurement regarding gastric distension, which make it more difficult to determine differences in gastric distension than when using quantitative measurements in laparoscopic cholecystectomy. Accordingly, we developed a new quantitative tool to measure severity of gastric distension. The aim of this study was to compare the quantitative clinical performance of the SLIPA with the LMA ProSeal with regard to intensity of gastric distension when used in patients undergoing laparoscopic cholecystectomy. We also compared fiberoptic view of the glottis, complications during emergence, and the severity of blood stain and postoperative sore throat.
METHODS The study protocol was approved by the Institutional Review Board of Chung-Ang University School of Medicine [c2011091 (541)] and the study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12611001189910) (https://www.anzctr.org.au/Trial/ Registration/TrialReview.aspx?id=347718). This study was carried out according to the principles of the Declaration of Helsinki (2000) and written informed consent was obtained from all patients. We recruited 124 healthy (ASA 1 to 2) individuals, aged 18 to 80 years, who required elective laparoscopic cholecystectomy and were eligible for enrollment in the study. We excluded patients with a history of diabetes
Surg Laparosc Endosc Percutan Tech
Volume 24, Number 3, June 2014
Surg Laparosc Endosc Percutan Tech
Volume 24, Number 3, June 2014
mellitus, gastroesophageal reflux, other neurological or musculoskeletal diseases, obesity (body mass index >30 kg/ m2), or with features or history of a difficult airway. The decision to enroll was made by one author who did not otherwise participate in this study. The patients were randomly divided into a SLIPA (n = 62) and a LMA ProSeal (n = 62) group. Randomization into 1 of the 2 groups was based on random table generated using R-program. Block randomization with a block size of 4 or 6 and equal allocation was used to prevent imbalances in treatment assignments. The randomization sequence was generated by a statistician who is not involved with the study. Patient group allocation was revealed to the investigator immediately before induction of anesthesia by means of numbered, sealed envelopes. One anesthesiologist with >4 years of experience with airway management using LMA ProSeal and with >1 year of experience with SLIPA was selected to administer supraglottic airway for this study. A second anesthesiologist recorded data as an independent observer. No premedication was given. After placement of standard monitoring systems (electrocardiography, noninvasive arterial blood pressure sensing, and pulse oximetry) and BIS monitoring system and preoxygenation for 3 minutes, lidocaine (0.5 mg/kg) was administrated intravenously to prevent propofol injection pain. Propofol was started at a plasma concentration of 3 to 4 mg/mL with remifentanil (4 to 6 ng/mL). Rocuronium (0.6 mg/kg) was given when the patient lost consciousness. Ventilation was controlled through a facemask with 100% O2. To avoid gastric insufflation, the lungs were gently ventilated with maintaining adjustable pressure-limiting valve at 15 cm H2O until sufficient jaw relaxation. When the jaw was sufficiently relaxed, the SLIPA or LMA ProSeal was inserted. In the SLIPA group, size was chosen by the width across the thyroid cartilage.3 In the LMA ProSeal group, size 3 was used for patients weighing 70 kg according to the manufacturer’s recommendations. Normal saline was used for lubrication in both supraglottic airways. After insertion, the cuff in the LMA ProSeal group was maintained 10% difference existed between the inspiration and expiration tidal volume on spirometry (S/5TM Compact anesthesia monitor; Datex-Ohmeda, Tewksbury, MA) at any time during the operation except during position change and the start or finish of pneumoperitoneum, we attempted same manipulation to adjust the supraglottic airway. However, if equal manipulation was not effective, it was recorded as maintenance failure and the supraglottic airway was changed to an endotracheal tube. Anatomic fit was checked using a flexible fiberoptic bronchoscope (Olympus BF-3C40; Olympus Optical, Tokyo, Japan) and this was graded by a second anesthesiologist. The fiberoptic view was assessed by the grading system of Joshi et al15: grade 1, vocal cords not seen; grade 2, vocal cords plus the anterior epiglottis seen; grade 3, cords plus the posterior epiglottis seen; and grade 4, only vocal cords seen. Peritoneal insufflations pressure was maintained at 15 mm Hg using CO2. After the patient was placed in reverse Trendelenburg position (30 degrees) and tilted downward to the patient’s left (10 degrees), the surgeon, who did not know which supraglottic airway was used, assigned a gastric distension score by using a direct visualizing laparoscope (pregastric distension score). Before the CO2 was evacuated and patient position changed at the end of surgery, the surgeon again assigned a gastric distension score (postgastric distension score). The scores of all cases were assessed by the same surgeon (rater 1). The gastric distension score scale ranged from 0 to 10 (Fig. 1). An independent examiner (rater 2) evaluated gastric distension scores through recorded screen on a separate workstation without any prior knowledge of the patient’s history or surgery. In addition, we defined the gastric distension score >5 as manipulation-needed case, of which the incidences were evaluated. At the end of the operation, neostigmine and glycopyrrolate were given to reverse neuromuscular block. The supraglottic airway was removed when the patient resumed spontaneous breathing (when the VT reached 8 mL/kg and the patient was able to obey commands) and it was inspected for the presence of visible regurgitant or any blood. Any breathing problems were recorded in emergence (including cough, vomiting, laryngospasm, or need for positive ventilation or airway intervention). One blinded investigator collected the postoperative sore throat score at www.surgical-laparoscopy.com |
217
Surg Laparosc Endosc Percutan Tech
Cha et al
Volume 24, Number 3, June 2014
FIGURE 1. The gastric distension score scale.
30 minutes and 1 day after emergence (none, mild, moderate, and severe). The primary outcome measurement of the study was the comparison of the degree of gastric distension between 2 groups at the end of surgery (postgastric distension score). Additional analyses were performed with regard to pregastric distension score, anatomic fit, any problems during emergence, and the severity of blood stain and postoperative sore throat.
analyzed using the Mann-Whitney U test. The Wilcoxon signed-rank test was used to compare pregastric and postgastric distension scores, and the Spearman r was computed to determine the reliability of interrater agreement. Descriptive variables were subjected to w2 analysis or the Fischer exact test, as appropriate, and P-values
Gastric Distension With SLIPA Versus LMA ProSeal During Laparoscopic Cholecystectomy: A Randomized Trial Su Man Cha, MD,* Sihyun Park, RN, MSN,w Hyun Kang, MD, PhD,zy Chong Wha Baek, MD, PhD,z Yong Hun Jung, MD, PhD,z Young Joo Cha, MD, PhD,y8 and Junyong In, MD, PhDz
Background: We compared the quantitative clinical performances of the streamlined liner of the pharynx airway (SLIPA) and the ProSeal laryngeal mask airway (LMA ProSeal) regarding intensity of gastric distension in patients undergoing laparoscopic cholecystectomy. Methods: A total of 124 anesthetized, paralyzed patients (ASA 1 to 2; aged, 18 to 80 y) were randomly allocated for airway management with the SLIPA or LMA ProSeal. After induction of general anesthesia using total intravenous anesthesia and rocuronium, the intensity of gastric distension was accessed twice by 2 raters, respectively. We also compared the fiberoptic bronchoscopic view of the glottis, the severity of blood stain, and postoperative sore throat. Results: There were no statistically significant differences between groups for each gastric size. The change of gastric size within the SLIPA group was not statistically significant for both raters. Change within the LMA ProSeal group was significant in rater 2 (P = 0.045) and marginally significant for rater 1 (P = 0.056). Anatomic fit, complications during emergence, and the severity of blood stain and postoperative sore throat were similar in both groups. Conclusions: SLIPA is as efficacious as LMA ProSeal for use in patients without severe complications who are undergoing laparoscopic cholecystectomy. Key Words: gastric distension, laparoscopic cholecystectomy, laryngeal mask airway, SLIPA
(Surg Laparosc Endosc Percutan Tech 2014;24:216–220)
T
he streamlined liner of the pharynx airway (SLIPA; SLIPA Medical Ltd, London, UK) is becoming recognized as a safe and effective supraglottic airway for airway management during surgery.1–10
Received for publication January 16, 2013; accepted March 4, 2013. From the *Department of Anesthesiology and Pain Medicine, College of Medicine, Ajou University, Suwon; zDepartment of Anesthesiology and Pain Medicine; 8Department of Laboratory Medicine; yMedical Device Clinical Trials Center, College of Medicine, Chung-Ang University, Seoul; zDepartment of Anesthesiology and Pain Medicine, Ilsan Hospital, Dongguk University Medical Center, Goyang, Republic of Korea; and wSchool of Nursing, University of Washington, Seattle, WA. Supported by a grant of the Korea Healthcare Technology R&D Project, Ministry of Health and Welfare, Republic of Korea (A100054). The authors declare no conflicts of interest. Reprints: Hyun Kang, MD, PhD, Department of Anesthesiology and Pain Medicine, College of Medicine, Chung-Ang University, 224-1 Heukseok-dong, Dongjak-gu, Seoul 156-755, Korea (e-mail: [email protected]). Copyright r 2014 by Lippincott Williams & Wilkins
216 | www.surgical-laparoscopy.com
In laparoscopic cholecystectomy, because stomach and gallbladder are anatomically adjacent, gastric distension can obstruct the operator’s field of vision and interfere with surgical manipulation, which makes it imperative to lower the incidence and intensity of gastric distension. The effectiveness of supraglottic airway during laparoscopic cholecystectomy has been studied in terms of gastric insufflations and distension.11–13 Such studies reported that the classical laryngeal mask airway (LMA Classic) and the ProSeal laryngeal mask airway (LMA ProSeal; Laryngeal Mask Company, Henley-on-Thames, UK) were comparable to an endotracheal tube regarding the change in gastric distension during laparoscopic cholecystectomy. However, to the best of our knowledge, there is no study concerning the use of SLIPA in laparoscopic cholecystectomy. SLIPA was compared with LMA ProSeal on gastric distension only in lower abdominal laparoscopic surgery6,8 and ill-defined surgeries (requiring supine position during operation).5 In addition, although SLIPA offered the advantage of less perilaryngeal gas leakage and a similar incidence of gastric insufflations compared with LMA ProSeal in previous studies,5,6,8 the results did not include quantitative measurement regarding gastric distension, which make it more difficult to determine differences in gastric distension than when using quantitative measurements in laparoscopic cholecystectomy. Accordingly, we developed a new quantitative tool to measure severity of gastric distension. The aim of this study was to compare the quantitative clinical performance of the SLIPA with the LMA ProSeal with regard to intensity of gastric distension when used in patients undergoing laparoscopic cholecystectomy. We also compared fiberoptic view of the glottis, complications during emergence, and the severity of blood stain and postoperative sore throat.
METHODS The study protocol was approved by the Institutional Review Board of Chung-Ang University School of Medicine [c2011091 (541)] and the study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12611001189910) (https://www.anzctr.org.au/Trial/ Registration/TrialReview.aspx?id=347718). This study was carried out according to the principles of the Declaration of Helsinki (2000) and written informed consent was obtained from all patients. We recruited 124 healthy (ASA 1 to 2) individuals, aged 18 to 80 years, who required elective laparoscopic cholecystectomy and were eligible for enrollment in the study. We excluded patients with a history of diabetes
Surg Laparosc Endosc Percutan Tech
Volume 24, Number 3, June 2014
Surg Laparosc Endosc Percutan Tech
Volume 24, Number 3, June 2014
mellitus, gastroesophageal reflux, other neurological or musculoskeletal diseases, obesity (body mass index >30 kg/ m2), or with features or history of a difficult airway. The decision to enroll was made by one author who did not otherwise participate in this study. The patients were randomly divided into a SLIPA (n = 62) and a LMA ProSeal (n = 62) group. Randomization into 1 of the 2 groups was based on random table generated using R-program. Block randomization with a block size of 4 or 6 and equal allocation was used to prevent imbalances in treatment assignments. The randomization sequence was generated by a statistician who is not involved with the study. Patient group allocation was revealed to the investigator immediately before induction of anesthesia by means of numbered, sealed envelopes. One anesthesiologist with >4 years of experience with airway management using LMA ProSeal and with >1 year of experience with SLIPA was selected to administer supraglottic airway for this study. A second anesthesiologist recorded data as an independent observer. No premedication was given. After placement of standard monitoring systems (electrocardiography, noninvasive arterial blood pressure sensing, and pulse oximetry) and BIS monitoring system and preoxygenation for 3 minutes, lidocaine (0.5 mg/kg) was administrated intravenously to prevent propofol injection pain. Propofol was started at a plasma concentration of 3 to 4 mg/mL with remifentanil (4 to 6 ng/mL). Rocuronium (0.6 mg/kg) was given when the patient lost consciousness. Ventilation was controlled through a facemask with 100% O2. To avoid gastric insufflation, the lungs were gently ventilated with maintaining adjustable pressure-limiting valve at 15 cm H2O until sufficient jaw relaxation. When the jaw was sufficiently relaxed, the SLIPA or LMA ProSeal was inserted. In the SLIPA group, size was chosen by the width across the thyroid cartilage.3 In the LMA ProSeal group, size 3 was used for patients weighing 70 kg according to the manufacturer’s recommendations. Normal saline was used for lubrication in both supraglottic airways. After insertion, the cuff in the LMA ProSeal group was maintained 10% difference existed between the inspiration and expiration tidal volume on spirometry (S/5TM Compact anesthesia monitor; Datex-Ohmeda, Tewksbury, MA) at any time during the operation except during position change and the start or finish of pneumoperitoneum, we attempted same manipulation to adjust the supraglottic airway. However, if equal manipulation was not effective, it was recorded as maintenance failure and the supraglottic airway was changed to an endotracheal tube. Anatomic fit was checked using a flexible fiberoptic bronchoscope (Olympus BF-3C40; Olympus Optical, Tokyo, Japan) and this was graded by a second anesthesiologist. The fiberoptic view was assessed by the grading system of Joshi et al15: grade 1, vocal cords not seen; grade 2, vocal cords plus the anterior epiglottis seen; grade 3, cords plus the posterior epiglottis seen; and grade 4, only vocal cords seen. Peritoneal insufflations pressure was maintained at 15 mm Hg using CO2. After the patient was placed in reverse Trendelenburg position (30 degrees) and tilted downward to the patient’s left (10 degrees), the surgeon, who did not know which supraglottic airway was used, assigned a gastric distension score by using a direct visualizing laparoscope (pregastric distension score). Before the CO2 was evacuated and patient position changed at the end of surgery, the surgeon again assigned a gastric distension score (postgastric distension score). The scores of all cases were assessed by the same surgeon (rater 1). The gastric distension score scale ranged from 0 to 10 (Fig. 1). An independent examiner (rater 2) evaluated gastric distension scores through recorded screen on a separate workstation without any prior knowledge of the patient’s history or surgery. In addition, we defined the gastric distension score >5 as manipulation-needed case, of which the incidences were evaluated. At the end of the operation, neostigmine and glycopyrrolate were given to reverse neuromuscular block. The supraglottic airway was removed when the patient resumed spontaneous breathing (when the VT reached 8 mL/kg and the patient was able to obey commands) and it was inspected for the presence of visible regurgitant or any blood. Any breathing problems were recorded in emergence (including cough, vomiting, laryngospasm, or need for positive ventilation or airway intervention). One blinded investigator collected the postoperative sore throat score at www.surgical-laparoscopy.com |
217
Surg Laparosc Endosc Percutan Tech
Cha et al
Volume 24, Number 3, June 2014
FIGURE 1. The gastric distension score scale.
30 minutes and 1 day after emergence (none, mild, moderate, and severe). The primary outcome measurement of the study was the comparison of the degree of gastric distension between 2 groups at the end of surgery (postgastric distension score). Additional analyses were performed with regard to pregastric distension score, anatomic fit, any problems during emergence, and the severity of blood stain and postoperative sore throat.
analyzed using the Mann-Whitney U test. The Wilcoxon signed-rank test was used to compare pregastric and postgastric distension scores, and the Spearman r was computed to determine the reliability of interrater agreement. Descriptive variables were subjected to w2 analysis or the Fischer exact test, as appropriate, and P-values
