i-gel® from Intersurgical: clinical evidence listing

A comprehensive list of all known published clinical evidence on the device

Comparison of I-gel for general anesthesia in obese and nonobese patients

Prabha R, Raman R, Parvez Khan M, Kaushal D, Siddiqui A, and
Abbas H. Saudi J Anaesth. 2018 Oct-Dec; 12(4): 535–539

This prospective controlled study aimed to examine the clinical performance of the i-gel in both obese and non-obese patients. 32 patients were divided into two groups, group O (BMI >30 kg/m2) and group C (BMI between 18.5 and 29.9 kg/m2). A range of parameters were evaluated including OLP (primary outcome), leak fraction, time taken to insert the device, ease of insertion, fiberoptic glottis view and adverse events. Results have demonstrated that OLP was marginally higher in Group O in comparison to group C (but not statistically different). In regards to the other parameters and side effects, these were comparable in both groups. Therefore, the i-gel provides an effective tool for the airway management of both obese and non-obese patients.

Link to abstract

Comparison of I-gel versus Endotracheal Tube in Patients Undergoing Elective Cesarean Section: A Prospective Randomized Control Study

Panneer M, Babu S, Murugaiyan P. Anesth Essays Res. 2017 Oct-Dec; 11(4): 930–933 
 
The objective of this study was to compare the hemodynamic disturbances and possible complications caused by the i-gel and ETT in 80 patients (ASA II) undergoing cesarean receiving general anesthesia. A range of parameters was investigated including insertion time, ease of intubation, hemodynamics (insertion and removal) and postoperative complications (sore throat, blood on device, dysphagia, regurgitation, nausea, vomiting, laryngospasm and aspiration). Findings have demonstrated that patients in the ETT group had a higher incidence of difficult intubation, 20% higher mean arterial pressure and heart rate compared to the i-gel group. The ETT group also had a higher incidence of sore throat. Thus, the i-gel constitutes a superior alternative to the ETT in patients undergoing elective surgery under general anaesthesia.

Link to abstract.

Analyzing the efficacy of the I-gel supraglottic airway device in supine and lateral decubitus position

Saracoglu KT, Demir A, Pehlivan G, Saracoglu A, Eti Z. Anaesthesiol Intensive Ther. 2018 Sep 17

This prospective clinical trial assessed and compared the airway leak pressure and the fiberoptic view of the i-gel in both supine and lateral positions. Moreover, the impact of the i-gel insertion on haemodynamics was also monitored. 100 patients undergoing saturation biopsy were intubated with the i-gel in the supine position, which was subsequently changed to lateral position. Several measurements were taken after intubation and change of position, which included mean arterial pressure, heart rate, peripheral O2 saturation and end-tidal CO2. Furthermore, number of insertion attempts, insertion time, oropharyngeal leak pressure (OLP), and device placement were also recorded. The i-gel was successfully inserted in 88 patients on the first attempt and the insertion time was circa 8 seconds. Moreover, the OLP (27.45 mm Hg supine and 26.04 in lateral position) and fiberoptic view were comparable in both positions. Hence, the i-gel can be safely employed in both supine and lateral positions.

Link to abstract.

Clinical Comparison of I-Gel Supraglottic Airway Device and Cuffed Endotracheal Tube for Pressure-Controlled Ventilation During Routine Surgical Procedures

Dhanda A, Singh S, Bhalotra AR, Chavali S. Turk J Anaesthesiol Reanim. 2017 Oct;45(5):270-276

The adequacy of i-gel for pressure-controlled ventilation (PCV) in 60 patients undergoing elective surgery was assessed in this study. Patients were randomly assigned to the i-gel group or cuffed tracheal tube group. Several parameters were evaluated such as insertion time, number of attempts, ease of insertion and performance of the cardiovascular system. Furthermore, air leak, leak volume, leak fraction and pharyngolaryngeal (PL) morbidity were also assessed. Findings have shown that i-gel was easier to insert compared to the tracheal tube. Heart rate and mean arterial pressure were higher following tracheal tube but comparable between the two groups after few minutes. Moreover, the leak volume and leak fraction were comparable between the two groups at 15 cm H2O but significantly different at 20 and 25 cm H2O (higher in the i-gel group), and PL morbidity was significantly higher in the tracheal tube. Therefore, the i-gel represents a valuable alternative to the cuffed ETT if pressure is limited to 15 - 20 cm H2O.

Link to abstract.

Changes in hardness and resilience of i-gelTM cuffs with temperature: a benchtop study.

Dingley J, Stephenson J, Allender V, Dawson S, Williams D. Anaesthesia. 2018 Jul;73(7):856-862

To investigate the hypothesis that i-gel cuff softening occurs during warming to body temperature, this study used a probe to measure cuff hardness and resilience on devices mounted in a monitored water bath to provide 105,864 data points at 11 temperatures. Authors conclude that hardness and resilience reduced with warming, but at levels that may not be encountered during clinical use.

Link to abstract.