comparing the efficacy of two different types of supraglottic airway devices
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2023/11/060262
- Lead Sponsor
- Dr.Amit Rastogi
- Brief Summary
The prototypical supraglottic airway device (SAD) was invented by Dr Archie Brain in 1983.Its role has since evolved, substituting the clinical space of what traditionally was occupied by mask ventilation and tracheal intubation. These are a group of airway devices that are inserted into pharynx for ventilation. SADs may be broadly classified as cuffed peri-laryngeal sealers, cuffed pharyngeal sealers and cuff-less anatomically pre-shaped sealers. According to evolution they can also be classified as 1st and 2nd generation devices, where the 2nd generation devices are designed to protect against aspiration with a gastric channel resulting in better seal pressures. The 2nd generation SADs appear to out-perform the 1st generation devices in efficacy, safety and suitability for advance uses. Despite these recent advances, SADs still have several limitations which include the risk of aspiration, inadequate positive pressure ventilation, potential loss or blockage of airway, and air leakage from incorrectly sized SAD or hyperinflated cuff [1]. The airway pressure at which gas leaks into the oropharyngeal space is known as oropharyngeal leak pressure (OLP). OLP value is a measure of successful placement followed by functioning of SAD. Several studies have been done for the OLP measurements duringvarious SAD insertions [1-5]. SAD’s have several advantages over endotracheal tubes [12,13]Provides smooth induction of anaesthesia without much hemodynamic instability.Insertion is easier & faster than intubation especially for those unfamiliar with endotracheal intubation. Anesthesia with endotracheal intubation, although accompanied by a low incidence of complications requires the use of neuromuscular blocking agents, and has a longer extubationand recovery times. The I-gel (Intersurgical Ltd, Wokingham, Berkshire, UK) is a supraglottic airway device with an anatomically designed non-inflatable mask that snugly fits onto the peri laryngeal framework. The device has a buccal cavity stabiliser with an airway channel and a gastric tube insertion channel [6,14].Ambu Aura GainTM(Ambu,Ballerup,Denmark) is a relatively novel supraglottic airway device which has been introduced recently. It has features different from that of i-gel. AuraGain has an inflatable cuff and a curved body,in addition because the airway tube of Ambu AuraGain is wide can be used as a conduit for tracheal intubation[6].The present study is aimed at comparing the oropharyngeal leak pressure when inflatablesupraglottic device LMA Aura Gain and non-inflatable supraglottic device i- gel is inserted by the trainee anaesthesiologist.Aims and objectivesThe purpose of this study is to compare the oropharyngeal leak pressure, first attempt success rate, total insertion attempts, insertion time, oropharyngeal leak pressure, gastric tube insertion, fiber optic view and complications associated with Inflatable LMA aura gain and non-inflatable supraglottic airway device i- gel by trainee anaesthesiologist.Primary outcome:ï‚· To determine oropharyngeal leak pressure of Non-inflatable SAD I-gel and inflatable SAD Ambu Aura Gain by trainee Anaesthesiologist.Secondary outcome: ï‚· First-time insertion success rate of Non-inflatable LMA i-gel versus inflatable LMA Ambu Aura Gain by trainee Anaesthesiologist.ï‚· No. of attempts required for successful placement of SADï‚· Effective device insertion timeï‚· Fiberoptic grading of SAD placementï‚· Ease of insertion of gastric tube ï‚· Complications- staining of LMA after removal, sore throatï‚· Ease of insertion by the traineeMaterial and MethodsStudy Design and Sample SizeThe samples size calculation was based on a previous study [Theiler LG, et al. 2009](22,23)reporting that the OLP of the i-gelâ„¢ was 27±9 cmH2O. Assuming that a difference of 20% in the OLP was clinically significant, at minimum two-sided 95% confidence interval and at 90% power of the study, required 60 patients in each group. Finally, a total of 130 patients will be randomized with 65 patients in group1 and 65 patients in group 2. Sample size was estimated using software “Power analysis and sample size, version-16 (PASS-16)â€.Study SettingTertiary care hospital in northern India.Inclusion Criteria1. ASA I and II patients2. Both male and female patients between 18-65 years of age3. Elective procedures(Duration of surgery less than 3 hours)4. Patient with BMI less than 30 kg/m2Exclusion Criteria1. Patients unable (legally incompetent) or unwilling to give consent.2. ASA III/IV patients3. Patients with BMI more than 30 kg/m24. Patients in whom Supraglottic devices are contraindicated.5. Patients with neurological or cognitive deficits, anticipated difficult airway.6. Patients with increased risk of aspiration.7. Patients with reduced cardiopulmonary reserve.Material and MethodFollowing approval from the Institutional Ethics Committee and registering the trial in CTRI and after obtaining written and informed consent from all-participating patients, a prospective randomized control study will be conducted to compare non inflatable SAD (supraglottic airway device) I-gel versus Inflatable SAD LMA Ambu Aura Gain. All trainee anesthesiologists will be trained with audio, visual and manikin-based skill learning of LMA insertion. Training Anaesthesiologist will be the one who has joined the Department of Anaesthesiology within 3years. All trainees will be trained on both the SAD devices, explaining its preparation, lubrication of the device, insertion technique, fixation, and evaluation of its efficacy. The trainee will also assist and witness at least 20 LMA insertions in operative room before they participate in the study. Trainee will be chosen with randomization for the type of LMA insertion during the study. During the pre-operative visit, the detailed history will be recorded and clinically examined. Informed written consent will be obtained from all the patients. On the day of the surgery, the patient will be kept fasting for 6 hours to solid food and 2 hours to clear liquids prior to entering the operating room.The trainee will be randomly categorized into two groups (Group A: Ambu Aura Gain and Group I: I-gel) by computer-generated random numbers that were enclosed in a sealed envelope opened only at the time of induction. The sizes of the I-gel and Ambu Aura Gain devices are as per the manufacturer’s recommendation and are based on the patients’ body weight, i.e., Size 3 for weight 30-60 kg and size 4 for 50-90 kg for the I-gel; and size 3 for weight 30-50 kg, size 4 for 50-70 kg and size 5 for 70-100 kg for the Ambu Aura Gain.After securing intravenous access, all patients will be monitored using non-invasive blood pressure, electrocardiogram (ECG), pulse oximeter (SpO2) and capnography. All patients will be pre-medicated with midazolam 1.5-2 mg and fentanyl 2 µg kg−1. Following pre-oxygenation with 100% oxygen for 3 minutes, anaesthetic induction will be initiated with i.v propofol 2 mg kg−1. The head placed in neutral position on a pillow. After the loss of motor response to jaw thrust LMA will be inserted by the trainee.A well lubricated Ambu Aura Gain will be inserted by keeping the handle/shaft approximately parallel to the patient’s chest and then pushing the device along the hard palate after opening themouth. Similarly, the I-gel will be introduced using a standard technique in which the device is firmly grasped, with the cuff outlet facing the chin and then gently guided along the hard palate until resistance is felt [11,12,17 to 19].The device will be either reinserted or the size of the device will be changed if an obvious leak is observed. If the insertion fails even after three attempts, an alternative device will be used and operator will be changed to consultant and that patient will be excluded from the study.Insertion time is defined as time needed for insertion of a prepared SAD insertion to its successful confirmation of effective ventilation with a visible etCO2 tracking on the monitor and bilateral chest movement. Correct position of SAD will be also be confirmed using “suprasternal notch†and “bubble†tests. The effective device insertion time starts when the prepared SAD device is picked up by the operator. Patients will undergo Pressure control ventilation (PCV mode) with a target tidal volume of 7-8 mLâ‹…kg−1. Anaesthesia will be maintained with air + oxygen mixture with sevoflurane and intermittent boluses of fentanyl. All patients will receive 1 g of injection Paracetamol post induction of anaesthesia as a standard protocol.Immediately after insertion, OLP will be determined by closing the adjustable pressure limiting valve of the breathing circuit, with a fresh gas flow of 3 L/min and the patient head in neutral position [7,10,14,15,16]. While increasing the airway pressure only up to 40 cmH2O, oropharyngeal leak was assessed by placing the stethoscope and hearing for noise over the patient’s neck, immediately lateral to the thyroid cartilage. The OLP will be the pressure in the circuit when noise is heard and there is equilibrium in the airway pressure in the breathing circuit[8]. After determination of the OLP, fiberoptic views will be obtained by anesthesiologist by placement of a fiberoptic scope [21] through the SAD. The fiberoptic scope is passed to a position just proximal to mask aperture bars and view is scored as follows Brimacombe scoring:4-Only cords seen;3-Cords plus posterior epiglottis seen ;2-Cords plus anterior epiglottis seen;1-Cords not seen but function adequate;0-Failure to function where cords not seen fiberoptically. Function is not relevant for scores 4 to 2 because the vocal cords are visible and any failure to function is not due to proper positioning [22].After the device has been successfully placed, a lubricated size 10 French G gastric tube will be inserted. The ease of insertion is graded as easy, difficult and impossible. The patients’ heart rate (HR), mean arterial blood pressure (MAP), peak airway pressure and SpO2 will be recorded base line, just after insertion of the LMA and then for every 10-minutes. SpO2<95% is considered as oxygen desaturation. Following surgery, the device is removed when the patient becomes awake and responsive. The integrity of the device and the presence of blood stains will be noted. The patient is inspected for any complications related to LMA insertion like - injury to the lips, tongue and teeth. On removal of the device cough, staining of LMA and sore throat and dysphagia (for next 24 hrs) will be recorded. PATIENT’S PROFORMAName:…………………………………………….Age…………Sex………………………CR No………………………………. Weight..…………Height……………………………….Diagnosis……………………………………………………………………..............................Comorbidities………………………………………Duration of Anaesthesia………………………..Complications- LMA staining, injury to lips, teeth , sore throat, cough and dysphagia Oropharyngeal Leak Pressure No.of SAD’s priorly placed by the trainee No. of LMA Insertion attempt takenAttempt no. of successful insertionLMA insertion timeDuration of surgeryPeak air way pressureBP and Heart rateSpo2CapnongramVariables AmbuAura Gain i-gelNo.of insertion attemptsï‚· Oneï‚· Twoï‚· ThreeOropharyngeal seal leak pressure(cm of H20)Ease of gastric tube insertionï‚· Easyï‚· Difficultï‚· ImpossibleVentilatory parametersHaemodynamic parametersFibreoptic anatomic view of glottic structuresBrimacombe score4-Only cords seen3-Cords plus posterior epiglottis seen 2-Cords plus anterior epiglottis seen1-Cords not seen but function adequate0-Failure to function where cords not seen fiberopticallyEase of insertion by the performer• Easy• DifficultBlood stain on the deviceSore throatAny other side effectStatistical analysis:Mean and standard deviation (SD) or median (interquartile range) will be used for continuous variables depend on normality status. Categorical variables will be presented in number (%). Two proportion z test / Chi square test / Fisher exact test will be used to compare the proportions between the groups. Independent samples t test or its non-parametric tests to be used to compare the means or medians between the study groups. Two-way repeated measures ANOVA / Linear mixed model to be used to test the association between study groups and change in the measurements over the time points. All statistical analyses will be performed using SPSS software for windows version 23.0 (SPSS, Chicago, IL), with a significance level of 0.05.Review of literature:1.Berthold Moser et al conducted a study on oropharyngeal leak pressure of LMA protector vs the LMA Supreme which demonstrated that LMA Protectorâ„¢ enabled a higher OLP compared to the LMA Supremeâ„¢.2.Tomas Henlin et al studied Five different second -generation supraglottic airway devices ProSeal LMA,Supreme LMA,i-gel,SLIPA, and Laryngeal Tube Suction-D,were studied.Operators were inexperienced users with a military background,combat lifesavers,nurses,and physicians.They demonstrated that first attempt success rate was higher in the Supreme LMA(96%) followed by i-gel (87.9%).Oropharyngeal seal pressures were higher in the Laryngeal Tube Suction-D and ProSeal LMA groups than in other three devices3. Hur M et al performed a study on comparison of clinical performance of i-gel with that of AuraGain in patients with simulated cervical immobilization,which showed the rate of first attempt successful insertion of i-gel as 92.3% vs 86% for AuraGain. The i-gelâ„¢ and the AuraGainâ„¢ showed comparable oropharyngeal leak pressures .4.Myoung H.Kim et al compared the efficacy &safety of the LMA-Supreme and i-gel in anaesthetised and paralysed elderly patients which demonstrated the rate of successful insertion at the first attempt was similar between the two groups (94.3 vs. 82.7%, P= 0.072), more patients required device manipulation during insertion with the LMA-S than the i-gel (42.3 vs. 18.9%, P=0.011). Good fibreoptic laryngoscopy grades were significantly more common with the i-gel than the LMA-S (79.3 vs. 55.8%, P=0.042), and peak inspiratory pressures were lower in the i-gel group both immediately after insertion and at the end of surgery. Leak pressures were significantly higher in the i-gel group than the LMA-S group, both immediately after insertion and at the end of surgery (25.8 vs. 23.0, P=0.036; and 28.1 vs. 23.7, P < 0.001 respectively).5.Jee Eun Chang et al compared the LMA-Protectorâ„¢ and the i-gelâ„¢ in terms of adequacy of the airway seal, insertion time, ease and accuracy of insertion, and the incidence of postoperative sore throat,which concluded that The LMA-Protectorâ„¢ provided a better airway sealing effect than the i-gelâ„¢. 6.Chandra M. Kumar et al suggested replacing routinely practiced ‘blind’ insertion techniques with a “vision-guided†insertion of SADs which will provide objective evidence of correct SAD placement in the hypopharynx, adequate inflation of cuff, and correctly chosen SAD size, with the epiglottis resting on the outside of SAD without downfolding. If these conditions are met, air leak may be mitigated and airway obstruction avoided; the OLP will provide a meaningful and scientific proof of the SAD efficacy, paving the way for future comparative studies of SADs.REFERENCES1. Chandra M. Kumar1 , Tom C. Van Zundert 2, Edwin Seet3 and André A. Van Zunder2. Brimacombe J, Keller C. Does efficacy of seal and fibreoptic view change during anaesthesia with the laryngeal mask airway: a comparison of oxygen and oxygen- nitrous oxide gas mixtures. Acta Anaesthesiol Scand. 2000; 44: 1258–60. 3. Lan S, Zhou Y, Li JT, Zhao ZZ, Liu Y. Influence of lateral position and pneumoperitoneum on oropharyngeal leak pressure with two types of laryngeal mask airways. Acta Anaesthesiol Scand. 2017; 61: 1114–21.4. Moser B, Keller C, AudigeÌ L, Bruppacher HR. Oropharyngeal leak pressure of the LMA ProtectorTM vs the LMA SupremeTM; a prospective, randomized, controlled clinical trial. Acta Anaesthesiol Scand. 2019; 63: 322–8.5. Fujimoto M, Kubota F, Yamamoto T. The effect of rocuronium on ventilatory leak and sealing pressure using a supraglottic airway device: A randomized clinical trial. Acta Anaesthesiol Scand. 2020; 64: 1120–7. 6. Roopa Sachidananda1 , Safiya I. Shaikh1 , Milon Vasant Mitragotri1 , Vikas Joshi1 , Dharmesh Arvind Ladhad1 , Marutheesh Mallappa1 , Vikram Kemmannu Bhat7. Xue FS, Mao P, Liu HP, Yang QY, Li CW, He N, et al. The effects of head flexion on airway seal, quality of ventilation and orogastric tube placement using the ProSeal laryngeal mask airway. Anaesthesia. 2008;63:979–85.8. Keller C, Brimacombe JR, Keller K, Morris R. Comparison of four methods for assessing airway sealing pressure with the laryngeal mask airway in adult patients. Br J Anaesth. 1999;82:286–7.9. Moser B, Keller C, Audigé L, Bruppacher HR. Oropharyngeal leak pressure of the LMA Protectorâ„¢ vs the LMA Supremeâ„¢; a prospective, randomized, controlled clinical trial. Acta Anaesthesiol Scand. 2018;00:1–7. https://doi.org/10.1111/aas.1325610. Jee-Eun Chang1 ,Hyerim Kim1 , Jung-Man Lee1 , Seong-Won Min1,2, Dongwook Won1 , Kwanghoon Jun3 and Jin-Young Hwang111. Tomas Henlin,1 Michal Sotak,1 Petr Kovaricek,1 Tomas Tyll,1 Lukas Balcarek,1 and Pavel Michale12. Cork RC, Depa RM, Standen JR. Prospective comparison of use of the laryngeal mask and endotracheal tube for ambulatory surgery. AnesthAnalg 1994; 79: 719-213. Levitan RM, Kinkle WC. Initial anatomic investigation of I-gel airway: A novel supraglottic airway without inflatable cuff. Anaesthesia 2005; 60: 1022-6. [CrossRef]14. Alexiev V, Salim A, Kevin LG, Laffey JG. An observational study of the Baska mask® : a novel supraglottic airway. Anaesthesia 2012; 67: 640-5. [CrossRef] 15. Al-Rawahi SAS, Aziz H, Malik AM, Khan RM, Kaul N. A comparative analysis of the Baska® Mask vs Proseal laryngeal mask for general anesthesia with IPPV. Anaesth Pain & Intensive Care 2013; 17: 233-6. 9.16. Chen X, Jiao J, Cong X, Liu L, Wu X. A comparison of the performance of the i-gelTM vs the LMA laryngeal mask-SupremeTM during anesthesia: a meta-analysis of randomized controlled trials. PLoS One 2013; 8: e71910.17. i-gel User Guide. Wokingham. UK: Intersurgical ltd; 2009[Cross-Ref]18. Bamgbade OA, Macnab WR, Khalaf WM. Evaluation of the i-gel airway in 300 patients. Eur J Anaesthesiol. 2008;25:865–6[Cross-Ref]19. Teoh WH, Lee KM, Suhitharan T, Yahaya Z, Teo MM, Sia AT. Comparison of the LMA Supreme vs the iâ€gel in paralysed patients undergoing gynaecological laparoscopic surgery with controlled ventilation. Anaesthesia. 2010;65:1173â€1179.20. Timmermann A, Cremer S, Eich C, et al. Prospective clinical and fiberoptic evaluation of the Supreme laryngeal mask airway. Anesthesiology. 2009;110:262â€265. 3. Moser B, Audige L, Keller C, Brimacombe J, Gasteiger L, Bruppache21. Hur M, Choi S, Row HS, Kim TK. Comparison of the i-gelâ„¢ with the AuraGainâ„¢ laryngeal mask airways in patients with a simulated cervical immobilization: a randomized controlled trial. Minerva Anestesiol 2020;86:727-35. DOI: 10.23736/S0375-9393.20.14237-8) 22. Payne J.The use of the fibreoptic laryngoscope to confirm the position of the laryngeal mask.Anaesthesia 1989;44:86523. Theiler LG, Kleine-Brueggeney M, Kaiser D, Urwyler N, Luyet C, Vogt A, et al. Crossover comparison of the laryngeal mask supreme and the i-gel in simulated difficult airway scenario in anesthetized patients. Anesthesiology 2009;111:55–62.[Cross-Ref
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 130
- ASA I and II patients 2.
- Both male and female patients between 18-65 years of age 3.
- Elective procedures(Duration of surgery less than 3 hours) 4.
- Patient with BMI less than 30 kg/m2.
- Patients unable (legally incompetent) or unwilling to give consent.
- ASA III/IV patients 3.
- Patients with BMI more than 30 kg/m2 4.
- Patients in whom Supraglottic devices are contraindicated.
- Patients with neurological or cognitive deficits, anticipated difficult airway.
- Patients with increased risk of aspiration.
- Patients with reduced cardiopulmonary reserve.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine oropharyngeal leak pressure of Non-inflatable SAD I-gel and inflatable Immediate SAD Ambu Aura Gain by trainee Anaesthesiologist. Immediate
- Secondary Outcome Measures
Name Time Method First-time insertion success rate of Non-inflatable LMA i-gel versus inflatable LMA Ambu Aura Gain by trainee Anaesthesiologist.
Trial Locations
- Locations (1)
Sanjay Gandhi Postgraduate Institute of medical sciences,Lucknow
🇮🇳Lucknow, UTTAR PRADESH, India
Sanjay Gandhi Postgraduate Institute of medical sciences,Lucknow🇮🇳Lucknow, UTTAR PRADESH, IndiaDrAmit RastogiPrincipal investigator9793124468amit.rastogi.sgpgi@gmail.com