FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2017/05/008671 [Registered on: 26/05/2017] Trial Registered Retrospectively
Last Modified On: 25/05/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   comparison of two supraglottic airway devices 
Scientific Title of Study   A comparative analysis of the Baska mask vs.I-gel for general anesthesia in surgical patient undergoing laparoscopic cholecystectomy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Monika Mahajan 
Designation  Senior Resident 
Affiliation  Dr. Rajendra Prasad Govt. Medical College, Tanda 
Address  Department of Anaesthesia Dr. RPGMC Kangra

Kangra
HIMACHAL PRADESH
176001
India 
Phone  9781484200  
Fax    
Email  mon.mahajan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Usha Kumari Chaudhary  
Designation  Assistant Professor  
Affiliation  Dr. Rajendra Prasad Govt. Medical College, Tanda 
Address  Deptt of Anaesthesia Dr. Rajendra Prasad Govt. Medical College Tanda

Kangra
HIMACHAL PRADESH
176001
India 
Phone  9459301813  
Fax    
Email  chaudhary.ushaarvind@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Usha Kumari Chaudhary  
Designation  Assistant Professor  
Affiliation  Dr. Rajendra Prasad Govt. Medical College, Tanda 
Address  Deptt of Anaesthesia Dr. Rajendra Prasad Govt. Medical College Tanda

Kangra
HIMACHAL PRADESH
176001
India 
Phone  9459301813  
Fax    
Email  chaudhary.ushaarvind@gmail.com  
 
Source of Monetary or Material Support  
Head of department, department of anaesthesia, department of health and family welfare Dr. RPGMC, Tanda,Kangra, HP 
 
Primary Sponsor  
Name  Dr RPGMCTanda 
Address  Department of Anaesthesia, Dr. RPGMC Tanda Kangra H.P. 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Monika Mahajan  Dr. RPGMC,Tanda, Kangra,HP  Surgey Operation Theatre, Department of Anaesthesia,Dr. RPGMC,Tanda, Kangra,HP Tanda Kangra HP
Kangra
HIMACHAL PRADESH 
9781484200

mon.mahajan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  symptomatic patients of cholecystitis undergoing laparoscopic cholecystectomy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  comparison of baska mask versus Igel   comparison of baska mask and Igel for securing airway and the ventilator settings throughout the surgery for a surgery of less than 2 hous duration.  
Intervention  I GEL vs Baska Mask  The airway will be secured with with either I gel or Baska mask as device for airway management at the time of induction of anaesthesia 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
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. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/05/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Intubation of trachea using a tracheal tube requires high skill levels, continuous training and frequent practice1.The laryngeal mask airway(LMA)  may be used to provide a routine airway for use during general anaesthesia or less frequently as a conduit for tracheal intubation2.In case of the anticipated and unanticipated difficult airway the supraglottic airway have a special place in the difficult airway algorithm3. Since the introduction of the Laryngeal Mask Airway Classic(LMA-C), several other supraglotticdevices with improved designs  have been introduced in order to improve efficacy and safety.

These designs offer a cuff that allows a higher seal pressure than the LMA-C and a drain tube that allows venting of the stomach contents and blind insertion of standard gastric tubes4. Therefore, these new generation LMAs provides certain protection against regurgitation and prevent gastric insuffulation when correctly placed. These devices are a reasonable choice when performing anesthesia for procedures accompanied by high peak airway pressure, such as laparoscopic cholecystectomy5.

I-gel is a second generation supraglottic airway, made of a medical grade thermoplastic elastomer, designed to create a non-inflatable anatomical seal of the pharyngeal, laryngeal and peri-laryngeal structures.I-gel  is easy and reliable to insert and is ideal for use as a routine airway in anaesthesia as it provides high seal pressures and reduced trauma. An integrated gastric channel provides an early warning of regurgitation, facilitates venting of gas from the stomach and allows for the passing of a suction tube to empty the stomach contents to provide additional protection against aspiration and has the versatility to be applicable for use during 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 suction clearance. The Baska mask is a new supraglottic airway device, featuring non-inflatable cuff that may facilitate a better airway seal, seal increases with IPPV without gastric inflation and novel pharyngeal drainage system that may reduce the risk of lung aspiration, and integrated bite block.

Till date, no randomized study has been undertaken to judge its sealing pressure as compared to i-gel. We hypothesized that with its cuffless membranous bowl; the baska mask would withstand higher inflation pressures, have a faster placement time, and have no problem with diffusion of nitrous oxide despite longer duration of use that would lead to less postoperative laryngopharyngeal morbidity as compared to i-gel in patients undergoing elective surgical procedures of 2 hours or less duration.

 
Close