comparison of two supraglottic airway devices

Recruiting

Conditions: symptomatic patients of cholecystitis undergoing laparoscopic cholecystectomy

Registration Number: CTRI/2017/05/008671

Lead Sponsor: Dr RPGMCTanda

Brief Summary: Intubationof trachea using a tracheal tube requires high skill levels, continuoustraining and frequent practice1.The laryngeal mask airway(LMA) maybe used to provide a routine airway for use during general anaesthesia or lessfrequently as a conduit for tracheal intubation2.In case ofthe anticipated and unanticipated difficult airway the supraglottic airway havea special place in the difficult airway algorithm3. Since theintroduction of the Laryngeal Mask Airway Classic(LMA-C), several othersupraglotticdevices with improved designs have been introduced in order to improveefficacy and safety.

Thesedesigns offer a cuff that allows a higher seal pressure than the LMA-C and adrain tube that allows venting of the stomach contents and blind insertion ofstandard gastric tubes4. Therefore, these new generation LMAsprovides certain protection against regurgitation and prevent gastric insuffulationwhen correctly placed. These devices are a reasonable choice when performinganesthesia for procedures accompanied by high peak airway pressure, such aslaparoscopic cholecystectomy5.

I-gel is a second generation supraglottic airway, made of a medical gradethermoplastic elastomer, designed to create a non-inflatable anatomical seal ofthe pharyngeal, laryngeal and peri-laryngeal structures.I-gel is easy and reliable to insert and is idealfor use as a routine airway in anaesthesia as it provides high seal pressuresand reduced trauma. An integrated gastric channel provides an early warning ofregurgitation, facilitates venting of gas from the stomach and allows for thepassing of a suction tube to empty the stomach contents to provide additionalprotection against aspiration and has the versatility to be applicable for useduring difficult airway management, as a rescue device and a conduit for intubation(with fibreoptic guidance).

The Baska mask is a supraglottic airway with high volume suctionclearance. The Baska mask is a new supraglottic airway device, featuringnon-inflatable cuff that may facilitate a better airway seal, seal increaseswith IPPV without gastric inflation and novel pharyngeal drainage system thatmay reduce the risk of lung aspiration, and integrated bite block.

Till date,no randomized study has been undertaken to judge its sealing pressure ascompared to i-gel. We hypothesized that with its cuffless membranous bowl; thebaska mask would withstand higher inflation pressures, have a faster placementtime, and have no problem with diffusion of nitrous oxide despite longerduration of use that would lead to less postoperative laryngopharyngealmorbidity as compared to i-gel in patients undergoing elective surgicalprocedures of 2 hours or less duration.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 80

Inclusion Criteria

1.American Society of Anesthesiologists physical status score I or II 2.20 -70 yr old patient of either sex 3.Surgery time of less than 2 hr 4.An elective laparoscopic cholecystectomy.

Exclusion Criteria

1.A known or predicted difficult airway 2.A mouth opening of <2.5 cm 3.Increased risk of aspiration of gastric contents 4.Any pathology of neck or upper respiratory tract 5.Obesity (body mass index > 30 Kg/ m2).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success and ease of insertion, insertion time and air leak test of baska mask vs Igel	At the time point of securing airway and for next 5 minutes after securing airway, air leak pressures and leak fraction every 30min.till the end of surgery

Secondary Outcome Measures

Name	Time	Method
Ease of removal and post operative airway morbidity in form of sore throat, dysphonia, dysphagia	At the time of extubation at end of surgery and at 1 hour and two hours of removal of airway device.

Trial Locations

Locations (1): Dr. RPGMC,Tanda, Kangra,HP
🇮🇳
Kangra, HIMACHAL PRADESH, India
Dr. RPGMC,Tanda, Kangra,HP
🇮🇳Kangra, HIMACHAL PRADESH, India
Dr Monika Mahajan
Principal investigator
9781484200
mon.mahajan@gmail.com