1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - For individual participant data meta-analysis.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [ramanrajesh83@gmail.com].
   


6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2028?
   Response - Beginning 9 months and ending 36 months following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Clinical performance of I-gel and I-gel plus for airway management of obese patients: A prospective randomised controlled study

INTRODUCTION

Obesity has emerged as a global health concern, and its prevalence continues to rise, presenting unique challenges in various medical contexts, particularly during anesthesia and surgery.^[1] Airway management in obese patients poses distinct difficulties due to altered anatomy, increased adipose tissue, and a higher prevalence of comorbid conditions such as obstructive sleep apnea. As such, there is a growing need for effective and safe airway management strategies tailored to this specific population.

Clinical performance of I-gel and I-gel plus for airway management of obese patients: a prospective randomised controlled study

    I-gel is a new supraglottic airway device designed to fit the peri-laryngeal and hypo-pharyngeal structures without the use of an inflatable cuff, made of a thermoplastic elastomer (styrene ethylene butadiene styrene) with a soft durometer (hardness) and gel like, provides a seal in patients with a wide range of anatomical variation. The claimed potential advantages include ease of insertion and use with minimal tissue compression and congestion, airway complications and stability following insertion. The I-gel is a second-generation supraglottic airway device designed to provide a non-invasive means of securing the airway. A previous anatomical study in cadavers has shown that the I-gel™ is capable of achieving a good peri-laryngeal seal without the requirement for an inflatable cuff.^[2]

    It also has features designed to allow a gastric tube to be passed into the stomach. The anatomically shaped non inflatable cuff may be responsible for higher oropharyngeal leak pressure that suggests better safety and provide positive pressure ventilation.^[3]

Several studies have investigated the role of the I-gel in obese patients. Here are references to some of these studies-

Prabha et al compared I-gel for general anesthesia in obese and nonobese patients.^[4] In this study they concluded that i-gel is as effective in obese patients as in nonobese patients when used for securing the airway for surgical procedures.

Singh et al did a comparative evaluation of ProSeal laryngeal mask airway, I-gel and Supreme laryngeal mask airway in adult patients undergoing elective surgery a randomised trial study.^[5] They found that PLMA provides better sealing pressure but takes longer to insert. I-gel and SLMA have similar sealing pressures. I-gel insertion time is quicker.