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CTRI Number  CTRI/2020/07/026406 [Registered on: 07/07/2020] Trial Registered Prospectively
Last Modified On: 03/07/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two supraglottic airways in key hole surgeries 
Scientific Title of Study   Comparison of AIR-Q LMA with Baska Mask in patients undergoing laparoscopic surgeries under general anaesthesia with positive pressure ventilation. A randomized control study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Preethi P 
Designation  MD ANAESTHESIA POST GRADUATE STUDENT 
Affiliation  S N MEDICAL COLLEGE 
Address  Dr PREETHI P 1ST YEAR MD ANAESTHESIA STUDENT S N MEDICAL COLLEGE BAGALKOT--587102

Bagalkot
KARNATAKA
587102
India 
Phone  9652101885  
Fax    
Email  preethipalampalli@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ramesh Koppal  
Designation  Professor 
Affiliation  S N Medical college, bagalkot  
Address  Dept of anaesthesia S N MEDICAL COLLEGE Navanagar BAGALKOT
b 24, S N Medical college staff quarters, navanagar, Bagalkot
Bagalkot
KARNATAKA
587102
India 
Phone  9845504515  
Fax    
Email  rameshkoppaldr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Preethi P 
Designation  MD ANAESTHESIA POST GRADUATE STUDENT 
Affiliation  S N MEDICAL COLLEGE 
Address  Dr PREETHI P 1ST YEAR MD ANAESTHESIA STUDENT S N MEDICAL COLLEGE BAGALKOT--587102


KARNATAKA
587102
India 
Phone  9652101885  
Fax    
Email  preethipalampalli@gmail.com  
 
Source of Monetary or Material Support  
S N Medical college and H S K Hospital Bagalkot 
 
Primary Sponsor  
Name  S NIJALINGAPPA MEDICAL COLLEGE AND HSK HOSPITAL 
Address  S NIJALINGAPPA MEDICAL COLLEGE AND HSK HOSPITAL, BAGALKOT 587102 
Type of Sponsor  Research institution and hospital 
 
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 
Preethi Palampalli  SN Medical college and HSK Hospital Bagalkot  1st floor, Major OT complex,IPD block
Bagalkot
KARNATAKA 
9652101885

preethipalampalli@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SNMC-INSTITUTIONAL EHICS COMMITTEE ON HUMAN SUBJECTS RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  AIR Q and Baska mask   Securing airway with LMA in Laparoscopic surgeries 
Intervention  Laryngeal mask airway  Ease of insertion, Oropharyngeal seal pressure 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA 1 & 2
Patients undergoing laparoscopic surgeries.
BMI- <30 
 
ExclusionCriteria 
Details  patient refusal to give consent
anticipated difficult airway
patients who are prone for gastric aspiration
patients with neck pathologies
pregnancy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Ease of insertion and oropharyngeal leak pressure in elective laparoscopic surgeries.  24hrs after insertion of LMA 
 
Secondary Outcome  
Outcome  TimePoints 
Assessing the post extubation sore throat, airway bleeding.  24hrs after insertion of LMA 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   11/07/2020 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Damodaran S et al,[1] conducted a prospective randomized controlled trial among 75 patients aged between 18-60 years, divided into 3 equal groups to compare OLP, ease of device insertion, time for placement of device, number of attempts to insert device and ease of gastric tube insertion in Air-Q, i-gel and LMA-S. Time taken for Air-Q insertion was higher than time taken for i-gel and LMA-S. It was concluded that all three were equally efficacious in terms of routine airway management. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

 Advantages of using supraglottic airway devices for airway management include avoidance of laryngoscopy, increased ease of placement, better hemodynamic stability, to provide clear airway a quicker manner and are designed to overcome the disadvantages of endotracheal intubation like soft tissue injury, exaggerated haemodynamic response.

 Newer SGA(supraglottic airway device) devices have also overcome the limitations of first generation SGA  devices which has lower orpharangeal leak pressure and also reduces the complications of laryngospasm, cough on removal, hoarseness of voice and sore throat which are higher in endotracheal intubation.

 AIR Q is  a  second generation supraglottic airway device that has better cuff, it has removable connector ,large inlet, anatomical bowl and built (mask heel improve placement and seal),epiglottis elevator( which will opens the airway to maximise the access),it has guide ramp( helps to direct the scopes & tube placement, it has a safety hole which provides gas exchange if main tube becomes occluded . Air Q can be a conduit for tracheal intubation.

The Baska Mask is a third generation supraglottic airway device with a non inflatable preformed cuff, an oesophageal drainage inlet, and side channels to facilitate aspiration of gastric contents, and an integrated bite block. 

Many studies have established utility and advantages of AIR Qand Baska mask independently in laparoscopic surgeries. Currently there are no studies in english literature which compare AIR Qand Baska mask in adult patients undergoing laparoscopic surgery. In this study we are comparing the oropharyngeal leak pressure, ease of insertion and complications between AIR Qand Baska mask in adult patients undergoing laparoscopic surgery so as to find out better SGA amongst these two.

 
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