LMA Proseal a safe alternative to Endotracheal intubation for prolonged hepatobiliary surgery: a pilot study
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Primary Objective is to assess feasibility of LMA Proseal by means of ventilatory efficacy and pulmonary gas exchange in prolonged hepatobiliary surgery and to compare its efficacy with endotracheal tube.
研究概览
简要总结
General anesthesia is considered essential for upper abdominal surgery and endotracheal intubation is conventionally used for it.
Since the introduction of laryngeal mask airway (LMA) in 1980s (1) it has replaced endotracheal intubation in many circumstances for maintenance of airway in patients under general anesthesia.
LMA provides several advantages over ET tube by means of ease of insertion, reduced post-operative sore throat, dysphagia, tracheal trauma, vocal cord injury, improved hemodynamic stability during insertion and emergence from anesthesia(2) .However, there is concern regarding LMA not being a definitive airway. Theoretically there is possibility of inadequate ventilation, improper seal and most importantly pulmonary aspiration(3,4) .So, prolonged surgery, laparoscopic surgery are conventionally regarded as a relative contraindication for LMA use(5) .
However second generation LMA like Proseal LMA, provide better seal and with its gastric drainage channel provide improved safety for aspiration(6). Therefore, nowadays LMA has been used for even prolonged duration of surgery and some author have used it safely in surgeries lasting for as long as 5 to 11 hours (7).- Although the safety and efficacy of second generation airway has been proven but for more prolonged use where surgery may last for more than six hours conventionally endotracheal intubation is used and data regarding such prolonged use of LMA is also limited.
So a pilot study is to be conducted to assess the efficacy of Proseal LMA in patient undergoing prolonged hepatobiliary surgery and compare it with patients in whom endotracheal tube is used for general anesthesia.
Based on the results further RCTs can be performed in patients undergoing prolonged abdominal surgery.
References:
Brain, A. I. Te laryngeal mask—A new concept in airway management. Br. J. Anaesth. 55, 801–805.(1983).
Timmermann, A., Bergner, U. A. & Russo, S. G. Laryngeal mask airway indications: New frontiers for second-generation supraglottic airways. Curr. Opin. Anaesthesiol. 28, 717–726 (2015).
Asai, T. Complications with supraglottic airways: something to worry about or much ado about nothing?. Anesthesiology 116,
1183–1185 (2012).
Ramachandran, S. K., Mathis, M. R., Tremper, K. K., Shanks, A. M. & Kheterpal, S. Predictors and clinical outcomes from failed
laryngeal mask airway unique: A study of 15,795 patients. Anesthesiology 116, 1217–1226 (2012).
van Esch, B. F., Stegeman, I. & Smit, A. L. Comparison of laryngeal mask airway vs tracheal intubation: A systematic review on airway complications. J. Clin. Anesth. 36, 142–150. (2017).
6. Moser B, Audigé L, Keller C, Brimacombe J, Gasteiger L, BruppacherHR. A prospective, randomized trial of the Ambu AuraGainTM laryngealmask versus the LMA® protector airway in paralyzed, anesthetized adult men. Minerva Anestesiol 2018;84:684–92.
Moser B, Brimacombe J, Sharma B, Dutta A, Sood J, et al. (2017) Prolonged Use of the Laryngeal Mask Airway ProSealTM: A Report of Seven Cases Lasting 5-11 h. J Anesth Clin Res 8: 717. doi:10.4172/2155-6148.1000717
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients of ASA grade I, II, III undergoing hepatobiliary surgery in Institute of liver and biliary science where expected duration of surgery is ≥ 6 hours and gut handling during surgery is minimal.
排除标准
- •Patients with anticipated difficult airway Inadequate NPO status Obese, BMI more than 35 ASA grade IV, V with serious comorbidities.
- •Emergency surgeries Patient who has not given consent to participate in study.
结局指标
主要结局
Primary Objective is to assess feasibility of LMA Proseal by means of ventilatory efficacy and pulmonary gas exchange in prolonged hepatobiliary surgery and to compare its efficacy with endotracheal tube.
时间窗: base line, hourly parameter at 1st,2nd,3rd,4th,5th,6th, 7th,8th hour
Ventilatory efficacy will be evaluated by means of peak pressure, driving pressure, leak (discrepancy between inspiratory and expiratory tidal volume).
时间窗: base line, hourly parameter at 1st,2nd,3rd,4th,5th,6th, 7th,8th hour
Pulmonary gas exchange will be evaluated as PaO2, PaCO2, ETCO2.
时间窗: base line, hourly parameter at 1st,2nd,3rd,4th,5th,6th, 7th,8th hour
次要结局
- Hemodynamic variation during insertion and emergence(baseline, 0,1,3,5,10 minutes after insertion of LMA or ET tube, after discontinuation of anesthesia,time of extubation, 5 minutes post extubation)
- incidence of post operative nausea vomiting, postoperative pulmonary complications, hoarseness of voice, sore throat(up to 3 days post surgery)
研究者
Dr Deepak K Tempe
Institute of Liver & Biliary Sciences