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 who provide a methodologically sound proposal.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [apoorvag874@gmail.com].
   


6. For how long will this data be available start date provided 09-01-2024 and end date provided 01-01-2029?
   Response - Beginning 3 months and ending 5 years following article publication.
   


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

The management of airway in obese patient for general anesthesia is often a major concern of anesthesiologists. Intubating severely obese patients remain a challenging issue and can lead to life threatening complications. In difficult airway in obese patients, an oxygenation strategy can be implemented with supraglottic airway devices (SAD) to provide a bridge between facemask and tracheal tube in terms of anatomical position and degree of invasiveness.^[1] Following airway devices are examples of newer, second-generation SAD with improved safety profile and higher airway dealing pressures than older, first-generation SAD-

 Ambu Auragain

It is an anatomically curved, single-use SAD that features an integrated gastric access port and direct intubation capability using a standard endotracheal tube. It also acts as conduit for fibreoptic-guided endotracheal intubation.  ^[1,2]

I-gel

It is an anatomical device, without an inflatable cuff, achieving a mirrored impression of pharyngeal, laryngeal, peri-laryngeal structures. It accurately positions itself over the laryngeal framework providing a reliable seal. There is also an independent gastric drain tube that allows the insertion of gastric tube for the aspiration of air and the residual gastric fluid. A widened flat stem of I-gel has a rigid bite block that prevents the occlusion of airways during recovery.^[3-7]

LMA Protector airway

It is the one of the newer SADs having the following features-

a)    It has dual gastric channels.

b)    It is made up of 100% silicone, phthalate free and designed to conform to the anatomy silicone cuffs have been shown to reduce risk of sore throat and achieve higher seal pressures compared with PVC Cuffs.

c)    It has a cuff Pilot which has an integrated cuff pressure which is an indicator for single use airway management devices that enables continuous cuff pressure monitoring at a glance and facilitates easy, accurate adjustment when necessary.^[4,5,8,9]

Baska mask- It is self-recoiling, has membranous diaphragm without inflatable cuff acting as an effective seal against the larynx featuring an anatomically curved oval-shaped airway tube.  It has the following features-

a)    A unique, self-sealing membranous variable - pressure, non-inflatable, recoiling cuff made of medical grade silicone, designed in such a way that during IPPV, the seal opposes to the glottis incrementally to augment seal pressure with increasing airway pressure.

b)    It has two ports for gastric drainage.

c)    It has a tab for manually curving the mask to facilitate insertion.

d)    It has a 90-degree suction elbow, i.e., an extra connector for attaching suction to the proximal end of whichever of the two ports is used to keep the sump area clear.^[3,7,9]

AIM AND OBJECTIVES

Aim- To compare AMBU Aura gain, I-gel, Baska mask and LMA Protector for airway management of obese surgical patients.

Objective

●     Primary objective- To compare oropharyngeal leak pressure of I-gel, Ambu Auragain, LMA Protector and Baska mask, when managing airway of surgical patient with obesity.

●     Secondary objective- Following are the secondary objectives-

1.   To compare success rate of insertion of Ambu Auragain, I-gel, LMA Protector and Baska mask, when managing airway of surgical patient with obesity.

2. To compare time of insertion of Ambu Auragain, I-gel, LMA Protector and Baska mask, when managing airway of surgical patient with obesity.

3. To compare number of attempts of Ambu Auragain, I-gel, LMA Protector and Baska mask, when managing airway of surgical patient with obesity

4. To compare leak fraction of Ambu Auragain, I-gel, LMA Protector and Baska mask, when managing airway of surgical patient with obesity.

5. To compare fiber optic view of glottis through Ambu Auragain, I-gel, LMA Protector and Baska mask, when managing airway of surgical patient with obesity.

6. To compare the hemodynamic changes which are mean arterial pressure, heart rate and saturation at different duration of time which are- a. baseline hemodynamics, b. after induction hemodynamics c. after device placement hemodynamics, and d. after removal hemodynamics.

7. To compare the complications of Ambu Auragain, I-gel, LMA Protector and Baska mask, when managing airway of surgical patient with obesity from device insertion to 24 hours post -operative period.

REFRENCES-

1.    Moser, B, Keller, C, Audigé, L, Dave, HM, Bruppacher, HR. Fiberoptic intubation of severely obese patients through supraglottic airway- A prospective, randomized trial of the Ambu® AuraGainâ„¢ laryngeal mask vs the I-gelâ„¢ airway. Acta Anaesthesiol Scand. 2019; 63- 187–194.

2.    Preece G, Ng I, Lee K, Mezzavia P, Krieser R, Williams DL, Stewart O, Segal R. A randomised controlled trial comparing fibreoptic-guided tracheal intubation through two supraglottic devices- Ambu® AuraGainâ„¢ laryngeal mask and LMA® Fastrachâ„¢. Anaesth Intensive Care. 2018; 46(5)-474-9.

3.    Kara D, Sarikas CM. Comparison of the Baska and I-gel supraglottic airway devices- a randomized controlled study. Ann Saudi Med. 2019;39(5)-302-308.

4.    Chang JE, Kim H, Lee JM, Min SW, Won D, Jun K, Hwang JY. A prospective, randomized comparison of the LMA-protectorâ„¢ and I-gelâ„¢ in paralyzed, anesthetized patients. BMC Anesthesiol. 2019;19(1)-118.

5.    Weber U, Oguz R, Potura LA, Kimberger O, Kober A, Tschernko E. Comparison of the I-gel and the LMA-Unique laryngeal mask airway in patients with mild to moderate obesity during elective short-term surgery. Anaesthesia. 2011;66(6)-481-7.

6.    Prabha R, Raman R, Khan MP, Kaushal D, Siddiqui AK, Abbas H. Comparison of I-gel for general anesthesia in obese and nonobese patients. Saudi J Anaesth. 2018;12(4)-535-9.

7.    Rehab Abdel Raof Abdel Aziz, Yasser Mohamed Osman. Comparison of I-gel with Baska mask Airway for Controlled Ventilation in Obese Patients Undergoing Ambulatory Surgery- A Prospective Randomized Trial. Journal of Anesthesiology. 2017; 5(4)-29-35.

8.    Shariffuddin II, Chaw SH, Ng LW, Lim CH, Zainal Abidin MF, Wan Zakaria WA, Teoh WH. Clinical performance of the LMA Protectorâ„¢ airway in moderately obese patients. BMC Anesthesiol. 2020;20(1)-184

9.    Zundert Tv, Gatt S. The Baska mask^® -A new concept in Self-sealing membrane cuff extraglottic airway devices, using a sump and two gastric drains- A critical evaluation. J Obstet Anaesth Crit Care 2012; 2-23-30.