I-gel Supraglottic Airway Device Research Articles

Aintree Catheter Versus Gum Elastic Bougie for Airway Exchange Using the i-Gel Supraglottic Device: A Cadaver Study.

Airway compromise is the third leading cause of preventable death on the battlefield. Most combat medics carry supraglottic airway (SGA) devices for airway management. However, exchanging an SGA device for a definitive airway can be challenging, especially in austere environments. This study aims to compare the Aintree intubation catheter (AIC) to the gum elastic bougie (GEB) as adjuncts for performing airway device exchange with the i-gel SGA device in place. This randomized crossover cadaver study of 48 participants examined the success rate of two endotracheal introducers (AIC and GEB) when performing a blind airway exchange with an i-gel in place. Study participants were combat medics (MOS 68W), physician assistant students, physician assistant staff, emergency medicine (EM) physician residents, and emergency medicine attending physicians attending classes at the installation Medical Simulations Training Center. Each participant performed up to three attempts using both endotracheal tube introducers on the same cadaver. The primary outcome was successful airway exchange rate with each device, and the secondary outcome was time to successful airway exchange. Although the AIC had a slightly higher success rate of 33% compared to the GEB success rate of 30%, this result was not statistically significant, P = .56. Similarly, participants completed successful airway exchanges with the AIC faster, with a mean time of 86.5 seconds (95% CI: 71.2 to 101.9) versus 101.2 seconds (95% CI: 85.5 to 116.9) with the GEB. However, this result was also not statistically significant, P = 0.18. This study demonstrates no significant difference in success rate and time to completion of successful iterations of airway exchanges between the two devices. Although the AIC performed slightly better overall, these results are not statistically significant. Additionally, blind exchange intubations appear to be of high risk with minimal success, so we recommend against this technique in routine practice.

Fiberoptic Bronchoscope Guided Assessment of Vocal Cord Function Using Bailey's Manoeuvre With an I-Gel Supraglottic Airway Device in Patients Undergoing Thyroid Surgery: An Initial Exploratory Prospective Study.

Fiberoptic Bronchoscope Guided Assessment of Vocal Cord Function Using Bailey's Manoeuvre With an I-Gel Supraglottic Airway Device in Patients Undergoing Thyroid Surgery: An Initial Exploratory Prospective Study.

A Simpler Method for Choosing Adult i-gel Size: An Evaluation of Real-World Prehospital Data

ObjectiveThe i-gel supraglottic airway device (Intersurgical, Berkshire, UK) is commonly used in the United States and worldwide for prehospital airway management. Previous research has suggested that a sex-based method of size selection (4.0 for female patients and 5.0 for male patients) is superior to a weight-based method in patients undergoing elective anesthesia. Our objective was to compare a sex-based i-gel size selection strategy with a weight-based strategy using real-world prehospital data. MethodsThe ESO Data Collaborative 2018 to 2022 dataset was used. All initial i-gel insertion attempts in patients > 18 years of age were evaluated for inclusion. Insertion attempts were excluded if age, sex, weight, success, or device size was not documented. Logistic regression was used to compare the rate of insertion failure on the first attempt for the group placed in alignment with the weight-based but not sex-based method with the group placed in alignment with the sex-based but not weight-based method. ResultsAfter the application of the exclusion criteria, 39,867 initial i-gel insertion attempts were included. The overall rate of failure was 6.5% (2,585/39,867). The rate of unsuccessful i-gel placement was similar when i-gel devices were placed in alignment with a sex-based size selection method in comparison to i-gel placement in alignment with a weight-based selection strategy (6.0% vs. 6.4%). Logistic regression analysis did not reveal a significant difference between groups (odds ratio: 1.08; 95% confidence interval: 0.95-1.23). ConclusionThe use of a sex-based method of i-gel size selection may be equivalent with respect to the rate of unsuccessful i-gel placement on the first attempt in comparison to a weight-based method.

Use of i-Gel Supraglottic Airway in a Simulated Cardiac Arrest Resuscitation During Boat Rescue Transport by Los Angeles County Fire Lifeguard Division: A Proof-of-Concept Study

ObjectiveThe Los Angeles County Fire Department Lifeguard Division responds to water rescues and medical and dive emergencies across 72 miles of Southern California coastline and Catalina Island. Limited advanced life support resources make cardiac arrest resuscitations logistically challenging during transport to shore or the hyperbaric chamber. This proof-of-concept study looked to determine if an i-Gel (Intersurgical Complete Respiratory Systems, Wokingham, Berkshire, UK) supraglottic airway device would either become dislodged or compromise ventilations during prolonged resuscitation at high speeds over open water with an ongoing automatic chest compression device (ACCD). MethodsA simulated resuscitation was performed on the Los Angeles County Lifeguard rescue boat while underway at speeds up to 25 knots. A LUCAS ACCD (Jolife AB, Ideon Science Park, Lund, Sweden) and a size 3 i-Gel were used. The volume of ventilations and depth of compressions were continuously monitored using the AmbuMan Advanced manikin (Ambu, Ballerup, Denmark). ResultsThe i-Gel supraglottic airway device delivered appropriate ventilations measuring between 300 and 400 mL/breath when delivered on the upstroke of compression. The i-Gel did not dislodge during transport. ConclusionThe i-Gel supraglottic airway device appears to provide adequate ventilations without dislodgment during ongoing compressions with an ACCD during high-speed water transport.

A retrospective comparison of the King Laryngeal Tube and iGel supraglottic airway devices: A study for the CARES surveillance group

ObjectiveSupraglottic airway devices are increasingly used during the resuscitation of out-of-hospital cardiac arrest (OHCA) patients in the United States and worldwide. In this study, we aimed to compare the neurologic outcomes of OHCA patients managed with the King Laryngeal Tube (King LT) to the neurologic outcomes of patients managed with the iGel. MethodsWe used the Cardiac Arrest Registry to Enhance Survival (CARES) public use research dataset for our analysis. Non-traumatic OHCA cases with attempted EMS resuscitation enrolled from 2013-2021 were included. We used two-level mixed effects multivariable logistic regression analyses with treating EMS agency as the random effect to determine the association between supraglottic airway device and outcome. The primary outcome was survival with a Cerebral Performance Category (CPC) score of 1 or 2 at discharge. Secondary outcomes included survival to hospital admission and survival to hospital discharge. Age, sex, calendar year of OHCA, initial ECG rhythm, witnessed status (unwitnessed, bystander witnessed, 9-1-1 responder witnessed), bystander CPR, response interval, and OHCA location (private/home, public, institutional) were used as covariables. ResultsIn comparison to use of the King LT, use of the iGel was associated with greater neurologically favorable survival (aOR: 1.45 [1.33, 1.58]). In addition, use of the iGel was associated with greater survival to hospital admission (1.07 [1.02, 1.12]) and survival to hospital discharge (1.35 [1.26, 1.46]). ConclusionsThis study adds to the body of literature suggesting that use of the iGel during OHCA resuscitation is associated with better outcomes than use of the King LT.

Estimation of the median effective dose and the 95% effective dose of alfentanil required to inhibit the bronchoscopy reaction during painless bronchoscopy with i-gel supraglottic airway device: an Up-and-Down Sequential Allocation Trial.

BackgroundIn practice, the optimal dose of alfentanil that should be used when painless bronchoscopy is performed is unknown. The purpose of this study was to investigate the effective dose of alfentanil in suppressing bronchoscopy responses to painless bronchoscopy with an i-gel supraglottic airway device.MethodsPatients aged 18–70 years, with American Society of Anesthesiologists (ASA) physical status I–II, who planned to undergo painless bronchoscopy were recruited for this study. Alfentanil was administered intravenously 2 minutes before propofol administration. The response to bronchoscopy was measured, including oxygen saturation (SPO2) and changes in respiratory rhythm. The median effective dose of alfentanil (ED50) required to alleviate responses to the bronchoscopy was calculated using Dixon’s up-and-down method in the female and male groups. Probit analysis was used to generate a dose-response curve in each group.ResultsA total of 48 patients were recruited for the study including 25 females and 23 males. The ED50 of alfentanil for suppressing responses to painless bronchoscopy in females and males was 13.68±4.75 and 17.96±3.45 µg/kg, respectively. The difference was not statistically significant between the two groups (P=0.078). Probit analysis showed the ED50 of alfentanil in female bronchoscopy was 12.4 µg/kg [95% confidence interval (CI): 4.5 to 17 µg/kg]. In men, the ED50 of alfentanil was 16.4 µg/kg (95% CI: 12.1 to 20.1 µg/kg). According to the probit analysis, the 95% effective dose (ED95) of alfentanil was 22.4 µg/kg (95% CI: 17.5 to 67.3 µg/kg) in female bronchoscopy. In men, the ED95 of alfentanil was 23.3 µg/kg (95% CI: 19.8 to 46.2 µg/kg).ConclusionsOur data suggest that there were no obvious differences between men and women in the effective dose of alfentanil in painless bronchoscopy.

Observational Study Comparing the Safety and Efficacy of Igel Supraglottic Airway Device Insertion in Anesthetised Patients by Anesthesia Faculty versus Residents

Aims: Successful airway management is the first priority in a variety of emergency care and hospital scenarios. This study was an attempt to compare and find out how quickly a first-time resident can learn to insert an I-gel and secure the airway versus their trained counterparts, thereby proving the effectiveness of this I-gel innovation in airway patency maintenance.
 Study Design: Observational cross-sectional study.
 Place & Duration of Study: Department of Anesthesiology, Dr. D.Y. Patil Medical College, Hospital and Research Centre, Dr. D.Y. Patil Vidyapeeth, Pune, Maharashtra 411018 India, from August 2021 to December 2021.
 Methodology: Two groups of 80 patients belonging to ASA grade I and II, aged between 18 to 65 years, including either gender, posted for elective surgery under GA requiring I-gel Supraglottic Airway device (SAD) insertion, with informed consent. The patients underwent I-gel SAD insertion by Anaesthesia Faculty & Anaesthesia Residents respectively. Baseline vital hemodynamic parameters, the time taken for insertion, number of attempts made and the serial heart rate, arterial pressure, SpO2 and respiratory rate noted at the time of insertion and at one, three- and five-minutes following insertion were noted.
 Results: Faculty group outperformed the residents with regards to number of attempts taken and time taken for each attempt, however the numbers in both groups are still comparable with no stark differences.
 Conclusions: There’s a very short & easy learning curve for successful i-gel® insertion by novice practitioners as well as paramedical workers, which can be utilized during a variety of emergency care and pre-hospital scenarios with adequate training to ensure adequate airway protection.

A comparative study on the perfomance between I-gel® and Classic laryngeal mask airway in anaesthetized spontaneously breathing patients

The classic Laryngeal Mask Airway (c-LMA) is a first generation supraglottic airway device with an inflatable cuff forming a low pressure seal around the laryngeal inlet and permitting ventilation. I-gel is a supraglottic airway device made of thermoplastic elastomer which is soft gel-like and transparent. Unlike the classic LMA(c-LMA), I-gel does not have an inflatable cuff. In view of this, the present study was undertaken to compare the performance of the two supraglottic airway devices in spontaneously breathing adult patients posted for elective surgeries under general anesthesia.To compare the ease of insertion, number of insertion attempts, time for insertion, airway leak pressure, hemodynamic changes as well as perioperative complications such as cough sore throat between patients using the two devices.Sixty patients admitted in SRM medical college and research center scheduled for various elective surgical procedures under general anesthesia belonging to ASA class I and II were included in the study. They were randomly divided into two groups of 30 each using a random number generator. In group I, I-gel supraglottic airway device was used and in Group 2 classic laryngeal mask airway was used. Data was collected using a questionair containing socio-demographic details, details regarding performance of the device as well as hemodynamic changes and perioperative complications.The insertion was easy in 25 patients (83.3%) in group I, while in group II 15 patients (50%) had easy insertion. P=0.0 1781. The mean time of insertion for I-gel was (20. 17± 3 .91 seconds) which was significantly shorter compared to c-LMA (26.80 ±7.24 seconds) (P<0.001).There was no statistically significant difference between the devices with respect to number of attempts of insertion. Even though the airway leak pressure is not statically significant, the mean oropharyngeal leak pressure for I-gel was 20.40±5.68 (mm Hg), which was higher than c-LMA 18.73±5.06 (mm Hg), which is well within the normal limits to prevent aspiration. There were no statistically significant differences in hemodynamic changes. No Blood staining was seen after removal of device in I-gel group where it was observed in 2 (7%) patients in c- LMA group. Post removal cough was more in c -LMA (13 .3%) than l-gel (P= 0.04 SS*). Pharyngo-Laryngeal morbidity was more with classic LMA. Sore throat was more with the classic LMA (13 .3%) when compared to I-gel group (3%).We conclude that I-gel is a better airway when compared to c-LMA with respect to ease of insertion, shorter duration for insertion, adequate oropharyngeal seal with lesser pharyngo-laryngeal morbidity and less incidence of airway trauma.

Cost-effectiveness of the i-gel supraglottic airway device compared to tracheal intubation during out-of-hospital cardiac arrest: Findings from the AIRWAYS-2 randomised controlled trial

AimOptimal airway management during out-of-hospital cardiac arrest (OHCA) is uncertain. Complications from tracheal intubation (TI) may be avoided with supraglottic airway (SGA) devices. The AIRWAYS-2 cluster randomised controlled trial (ISRCTN08256118) compared the i-gel SGA with TI as the initial advanced airway management (AAM) strategy by paramedics treating adults with non-traumatic OHCA. This paper reports the trial cost-effectiveness analysis. MethodsA within-trial cost-effectiveness analysis of the i-gel compared with TI was conducted, with a six-month time horizon, from the perspective of the UK National Health Service (NHS) and personal social services. The primary outcome measure was quality-adjusted life years (QALYs), estimated using the EQ-5D-5L questionnaire. Multilevel linear regression modelling was used to account for clustering by paramedic when combining costs and outcomes. Results9296 eligible patients were attended by 1382 trial paramedics and enrolled in the AIRWAYS-2 trial (4410 TI, 4886 i-gel). Mean QALYs to six months were 0.03 in both groups (i-gel minus TI difference −0.0015, 95% CI –0.0059 to 0.0028). Total costs per participant up to six months post-OHCA were £3570 and £3413 in the i-gel and TI groups respectively (mean difference £157, 95% CI –£270 to £583). Based on mean difference point estimates, TI was more effective and less costly than i-gel; however differences were small and there was great uncertainty around these results. ConclusionThe small differences between groups in QALYs and costs shows no difference in the cost-effectiveness of the i-gel and TI when used as the initial AAM strategy in adults with non-traumatic OHCA.

Comparison of Proseal Laryngeal Mask Airway with the I-Gel Supraglottic Airway During the Bailey Manoeuvre in Adult Patients Undergoing Elective Surgery.

ObjectiveSince the inception of Bailey manoeuvre, various authors have advocated for the substitution of endotracheal tube (ETT) with a supraglottic airway device (SAD) before the emergence from anaesthesia. There is scant information about the ideal supraglottic device in the literature. The present study compared the Proseal laryngeal mask airway (LMA) with the I-gel SAD during the Bailey manoeuvre. The primary objective was to compare these for ease of insertion and adequate placement of supraglottic airway, whereas the secondary objective was comparison of haemodynamics following the Bailey manoeuvre.MethodsA total of 100 patients aged 18–60 years who were scheduled for elective surgery under general anaesthesia were randomised into 2 groups: group I (Bailey manoeuvre using Proseal LMA) and group II (Bailey manoeuvre using I-gel). The Bailey manoeuvre was performed 15 min before the end of surgery using the chosen supraglottic airway as per randomisation. We measured the ease of insertion (number of attempts required for insertion) and adequate placement (Brimacombe scoring) of SADs (fibre-optic bronchoscopy). Haemodynamic parameters were recorded until 10 min after the Bailey manoeuvre.ResultsThe groups were comparable in terms of demographic parameters. Both the devices were comparable in terms of ease of insertion (p>0.05). Significantly higher (p<0.05) Brimacombe scores were seen with the I-gel. Significant (p<0.05) rise in systolic blood pressure, diastolic blood pressure, and mean arterial pressure was observed at the insertion of SAD, removal of ETT, and at 1 min after the Bailey manoeuvre in Proseal LMA in contrast to the I-gel.ConclusionThis study showed that the I-gel provides a better glottic visualisation and haemodynamically superior profile compared with the Proseal LMA during the Bailey manoeuvre.

Randomized trial of the i-gel supraglottic airway device versus tracheal intubation during out of hospital cardiac arrest (AIRWAYS-2): Patient outcomes at three and six months

AimThe AIRWAYS-2 cluster randomised controlled trial compared the i-gel supraglottic airway device (SGA) with tracheal intubation (TI) as the first advanced airway management (AAM) strategy used by Emergency Medical Service clinicians (paramedics) treating adult patients with non-traumatic out-of-hospital cardiac arrest (OHCA). It showed no difference between the two groups in the primary outcome of modified Rankin Scale (mRS) score at 30 days/hospital discharge. This paper reports outcomes to 6 months. MethodsParamedics from four ambulance services in England were randomised 1:1 to use an i-gel SGA (759 paramedics) or TI (764 paramedics) as their initial approach to AAM. Adults who had a non-traumatic OHCA and were attended by a participating paramedic were enrolled automatically under a waiver of consent. Survivors were invited to complete questionnaires at three and six months after OHCA. Outcomes were analysed using regression methods. Results767/9296 (8.3%) enrolled patients survived to 30 days/hospital discharge and 317/767 survivors (41.3%) consented and were followed-up to six months. No significant differences were found between the two treatment groups in the primary outcome measure (mRS score: 3 months: odds ratio (OR) for good recovery (i-gel/TI, OR) 0.89, 95% CI 0.69–1.14; 6 months OR 0.91, 95% CI 0.71–1.16). EQ-5D-5L scores were also similar between groups and sensitivity analyses did not alter the findings. ConclusionThere were no statistically significant differences between the TI and i-gel groups at three and six months. We therefore conclude that the initially reported finding of no significant difference between groups at 30 days/hospital discharge was sustained when the period of follow-up was extended to six months.

Research paramedics' observations regarding the challenges and strategies employed in the implementation of a large-scale out-of-hospital randomised trial.

Introduction:AIRWAYS-2 was a cluster randomised controlled trial (RCT) comparing the clinical and cost effectiveness of the i-gel supraglottic airway device with tracheal intubation in the initial airway management of out-of-hospital cardiac arrest (OHCA). In order to successfully conduct this clinical trial, it was necessary for research paramedics to overcome multiple challenges, many of which will be relevant to future emergency medical service (EMS) research. This article aims to describe a number of the challenges that were encountered during the out-of-hospital phase of the AIRWAYS-2 trial and how these were overcome.Methods:The research paramedics responsible for conducting the pre-hospital phase of the trial were asked to reflect on their experience of facilitating the AIRWAYS-2 trial. Responses were then collated by the lead author. A process of iterative revision and review was undertaken by the research paramedics to produce a consensus of opinion.Results:The main challenges identified by the trial research paramedics related to the recruitment and training of paramedics, screening of eligible patients and investigation of protocol deviations / reporting errors. Even though a feasibility study was conducted prior to the commencement of AIRWAYS-2, the scale of these challenges was underestimated.Conclusion:Large-scale pragmatic cluster randomised trials are being successfully undertaken in out-of-hospital care. However, they require intensive engagement with EMS clinicians and local research paramedics, particularly when the intervention is contentious. Feasibility studies are an important part of research but may fail to identify all potential challenges. Therefore, flexibility is required to manage unforeseen difficulties.

Anesthesia for resection of the trachea without its intubation

Introduction. Currently, there is a tendency for a number of post-intubation patients to develop post-tracheostomic cicatricial stenosis of the trachea. This dictates a need for the improvement of surgical and anaesthesiologic approaches to intubation management. Objective: Analysis of the specific parameters of anesthesia for cervical tracheal resection in patients with stenosis of the trachea without its intubation.Subjects and methods. We analyzed 12 cases of circular resection of the trachea due to benign stenosis. The degree of anesthetic risk was as follows: 11 patients – ASA 3, 1 patient – ASA 4. Tracheal stenosis persisted for 14±6 months before it was resected (Me 4, Min 1, Max 67). The length of the resected part of the trachea was 27±3 mm (Me 25, Min 15, Max 40), duration of surgery – 159±9 min (Me 160, Min 65, Max 240). The anesthesia strategy included the insertion of the I-Gel supraglottic airway device with a jet ventilation catheter put through the I-Gel. Temporary stenting of the stenosis zone of the trachea before surgery (if necessary) instead of bougienate was an important component of the anesthesia strategy. Mandatory use of sedation (dexmedetomidine) is suggested before and within 12 hours after surgery.Results. This strategy can be successfully implemented if the minimum diameter of the tracheal stenosis exceeds 7 mm (the jet ventilation catheter is necessary to be applied through this lumen and a fine bronchoscope used to monitor the state of the catheter tip). Preliminary stenting with metal stents was performed in 5 patients. The I-Gel lumen was wide enough to manipulate a flexible endoscope, a catheter guide was inserted for jet ventilation, and then the catheter itself was placed. The use of high-frequency ventilation mask it advisable to ensure adequate gas exchange at all stages of the surgery. Sedation with dexmedetomidine reduced the patient’s discomfort after the surgery due to the fixation of the patient’s head with stitches in a “nodding” position, which reduced anastomosis tension. In all 12 patients, this anesthesia strategy was successful and provided a more favorable environment for surgeons compared to the classical approach with the use of an endotracheal tube. In all patients, anastomosis healed by primary tension with no complications.Conclusion. The use of a supraglottic airway device, dexmedetomidine, and temporary stenting of the stenotic part of the trachea allow the surgeon to avoid tracheal intubation during circular resection and expand the range of anesthesiological tools during tracheal surgery.

Secure insertion of the i-gel supraglottic airway device in children: A cohort study.

Secure insertion of the i-gel supraglottic airway device in children: A cohort study.

Comparison of the Baska mask and the i-gel supraglottic airway devices in patients undergoing elective surgery.

The Baska mask and i-gel are two new types of second-generation supraglottic airway devices. The aim of this study was to compare these two devices in terms of quality of insertion, quality of ventilation and post-insertion complications. A total of 80 adult patients who were scheduled for elective surgery under general anaesthesia were randomised to two groups: Group BM: Baska mask (n = 40) and Group IG: i-gel (n = 40). The assessment focused on ease of insertion, number of attempts, insertion time, number of corrective manoeuvres, oropharyngeal leak pressure, tidal volume, peak airway pressure (PAP) and post-insertion complications. Group IG showed a significantly shorter median insertion time (13.3 [interquartile range, IQR 7.8] vs. 17.0 [IQR 9.6] s; P < 0.001), a higher percentage in the 'very easy' ease of insertion category (62.5% vs. 10.0%; P < 0.001), a higher percentage in the no corrective manoeuvre category (92.5% vs. 72.5%; P = 0.003) and a higher percentage in the no post-operative throat pain category (67.5% vs. 32.5%; P = 0.011) than Group BM. However, Group BM showed a significantly higher generated PAP than Group IG (12.7 [1.8] and 11.5 [2.2] cm H₂O, respectively; P = 0.010). There were no significant differences in other parameters. The i-gel was better than the Baska mask in terms of ease of insertion, speed of insertion, fewer corrective manoeuvres and less post-operative throat pain. However, the Baska mask had a better cuff seal, as shown by a higher generated PAP.

Efficiency of I-gel supraglottic airway device during mechanical ventilation in supine and lateral decubitus position in obese patient; prospective observational study

ABSTRACT Background I-gel supraglottic airway device has been widely used recently in anesthesia practice as an alternative to endotracheal intubation. However, its safety and feasibility in obese patients are still under investigations. The aim of this work was to evaluate the efficiency of I-gel in supine and lateral position in adult obese (BMI 30–40) mechanically ventilated patients undergoing short surgical procedures (60 − 120 min). Methods Prospective observational study was conducted at Kasr Alainy Hospital. A total of 40 obese patients with body mass index 30–40 aged between 20 and 60 years, American Society of Anesthesiologists class II & III scheduled for elective surgeries were enrolled in one group. We used the I-gel in supine position and lateral position in the same patient. The primary outcome was comparison between Oropharyngeal leak airway pressure during controlled ventilation in supine position after insertion of I-gel by 1 min and in lateral position. The secondary outcomes were fiberoptic view , insertion attempts and postoperative upper airway complications Results The leakage pressure required for I-gel did not show statistically significant difference between both supine and lateral positions (33.88 ± 7.34 cmH2O versus 33.10 ± 7.58 cmH2O) respectively. Fiberoptic view ranged between score 2 (8 patients) and score 3 (32 patients) in both supine and lateral position. I-gel was inserted in the first trial in 37 patients, the second trial in two patients and the third trial in one patient. None of the patients experienced postoperative swallowing difficulties, throat pain, hoarseness or postoperative nausea and vomiting. Only two patients (5%) showed blood on I-gel after removal. Conclusion The use of I-gel supraglottic airway device is safe and effective in both supine and lateral position in obese patients under mechanical ventilation with reliable ventilation and no postoperative airway complications. Clinical trial registration clinicaltrial.gov. ID: NCT04119245

Efficiency of I-gel Supraglottic Airway Device in Supine and Lateral Decubitus Position in Obese Patient

Efficiency of I-gel Supraglottic Airway Device in Supine and Lateral Decubitus Position in Obese Patient

Design and implementation of a large and complex trial in emergency medical services

BackgroundThe research study titled “Cluster randomised trial of the clinical and cost effectiveness of the i-gel supraglottic airway device versus tracheal intubation in the initial airway management of out-of-hospital cardiac arrest (AIRWAYS-2)” is a large-scale study being run in the English emergency medical (ambulance) services (EMS). It compares two airway management strategies (tracheal intubation and the i-gel) in out-of-hospital cardiac arrest. We describe the methods used to minimise bias and the challenges associated with the set-up, enrolment, and follow-up that were addressed.MethodsAIRWAYS-2 enrols adults without capacity when there is no opportunity to seek prior consent and when the intervention must be delivered immediately. We therefore adopted a cluster randomised design where the unit of randomisation is the individual EMS provider (paramedic). However, because paramedics could not be blinded to the intervention, it was necessary to automatically enrol all eligible patients in the study to avoid bias. Effective implementation required engagement with four large EMS and 95 receiving hospitals. Very high levels of data capture were required to ensure study integrity, and this necessitated collaborative working across multiple organisations. We sought to manage these processes by using a large and comprehensive electronic study database, implementing efficient trial procedures and comprehensive training.ResultsSuccessful implementation of the study design was facilitated by the approaches used. The necessary regulatory and ethical approvals to conduct the study were secured, and benefited from strong patient and public involvement. Early and continued consultation with decision makers within the four participating EMS resulted in a coordinated approach to study set-up. All receiving hospitals gave approval and agreed to collect data. A comprehensive database and programme of training and support were implemented. More than 1500 paramedics have been recruited to the study, and patient enrolment and follow-up has proceeded as planned.ConclusionCare provided by EMS needs to be based on evidence. Although participants may be experiencing life-threatening emergencies, high-quality pre-hospital research is possible in well-designed and well-managed studies. The approaches described here can be used to support successful research that will lead to improved treatment and outcomes in similar patient groups.Trial registrationISRCTN08256118. Registered on 22 July 2014.

Analysing the efficacy of the I-gel supraglottic airway device in the supine and lateral decubitus positions.

The advantages of the I-gel supraglottic airway device include ease and speed of insertion, reduced trauma incidence, an integral bite block, gastric access, a non-inflatable cuff and superior seal pressure. The primary goal of this study was to compare airway leak pressures and the fibreoptic view in the supine and lateral positions. Our secondary aim was to analyse the effects of I-gel insertion on haemodynamic parameters. One hundred patients undergoing saturation biopsy due to prostatic hyperplasia were recruited to this prospective randomised study. An I-gel device was inserted in the supine position. Taking of measurements, patients were placed in the lateral decubitus position. Mean arterial pressure, heart rate, peripheral O₂ saturation and end-tidal CO₂ were recorded before and after insertion. We recorded the number of attempts and insertion time for the I-gel device. Oropharyngeal leak pressures and I-gel device positioning were scored in the lateral decubitus and supine positions. It was possible to insert the I-gel device in 88 patients on the first attempt. The median time for insertion was 7.97 ± 2.18 sec. The mean arterial pressure and heart rate decreased 1 and 2 min after insertion. Oropharyngeal leak pressure was similar in the supine (27.45 ± 5.37 mm Hg) and lateral decubitus positions (26.04 ± 4.92 mm Hg) (P > 0.05). On fibreoptic examination through the I-gel device, the scores of patients were comparable in different positions (P = 0.542). As there was no significant difference in oropharyngeal leak pressure and fibreoptic view, we concluded that the I-gel device may be used safely in both the supine and lateral positions.

Comparison of Clinical Performance of Supraglottic Airway Devices I– gel vs LMA-Proseal in Paediatric Elective Surgeries

Comparison of Clinical Performance of Supraglottic Airway Devices I– gel vs LMA-Proseal in Paediatric Elective Surgeries