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CTRI Number  CTRI/2017/12/010782 [Registered on: 06/12/2017] Trial Registered Prospectively
Last Modified On: 06/12/2017
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Assessment of new airway device [Gnana Laryngeal Airway]: a preliminary clinical study. 
Scientific Title of Study   To evaluate a novel airway device, Gnana Laryngeal Airway in clinical practice: A pilot study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DHEERAJ KAPOOR 
Designation  Associate Professor 
Affiliation  Govt. medical College and Hospital, Chandigarh 
Address  Department of Anaesthesia and Intensive Care, D block, Level 5, Govt. Medical College and Hospital, Sector 32B, Chandigarh-160030

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121549  
Fax    
Email  kapoor.dheeraj72@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DHEERAJ KAPOOR 
Designation  Associate Professor 
Affiliation  Govt. Medical College and Hospital, Chandigarh 
Address  Department of Anaesthesia and Intensive Care, D block, Level 5, Govt. Medical College and Hospital, Sector 32B, Chandigarh-160030

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121549  
Fax    
Email  kapoor.dheeraj72@gmail.com  
 
Details of Contact Person
Public Query  
Name  DHEERAJ KAPOOR 
Designation  Associate Professor 
Affiliation  Govt. medical College and Hospital, Chandigarh 
Address  Department of Anaesthesia and Intensive Care, D block, Level 5, Govt. Medical College and Hospital, Sector 32B, Chandigarh-160030

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121549  
Fax    
Email  kapoor.dheeraj72@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College and Hospital, Sector 32, Chandigarh, India 
 
Primary Sponsor  
Name  Director Principal 
Address  Government Medical College and Hospital, Sector 32, Chandigarh-160030 
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 
DHEERAJ KAPOOR  Govt. Medical College and Hospital, Sector 32, Chandigarh  Department of Anaesthesia and Intensive Care, D Block, Level 5
Chandigarh
CHANDIGARH 		 9646121549

kapoor.dheeraj72@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committe (GMCH CHANDIGARH)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  American Society of Anesthesiologists (ASA) I/II patients scheduled for elective surgeries requiring general anaesthesia.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. American Society of Anesthesiologist (ASA) physical status 1 and 2 of either sex
2. Age group: 18-60 years
3. Body Mass Index (BMI): <30 kg/ m2
4. Scheduled for elective surgeries with duration <2 hours and requiring general anaesthesia with controlled ventilation
5. No concurrent participation in another study
 
 
ExclusionCriteria 
Details  1. Patients’ refusal or inability to give informed consent
2. American Society of Anesthesiologist (ASA) ≥3 physical status of either sex
3. Emergency surgical procedures
4. Upper respiratory tract infection
5. Anticipated difficult airway
6. Patients at increased risk of aspiration -gastro esophageal reflux disease, non fasting status, pregnancy
7. Cardiorespiratory or cerebrovascular disease
8. Diabetes Mellitus
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Ease of insertion grade of Gnana laryngeal airway device.   Immediately Post-induction of general anaesthesia. [Single time point] 
 
Secondary Outcome  
Outcome  TimePoints 
1.Time taken for Gnana laryngeal airway device insertion.
2. Oropharyngeal Leak Pressure of Gnana airway device.
3. Fibreoptic view grade of glottis after placement of Gnana airway device.
4. Ventilation variables [Peak airway pressure, Airway Resistance, Airway Compliance, Pulse oximetry, End-Tidal carbon dioxide pressure]
5. Any Malposition of Gnana laryngeal airway device.
6. Adverse effects post Gnana laryngeal airway device insertion.
 		 1. Immediately Post-induction of general anaesthesia
2. Immediately and 5 minutes after Gnana device insertion.
3.Immediately and 5 minutes after Gnana device insertion.
3. Immediately after Gnana device insertion.
4. Pre-induction of general anaesthesia, Immediate post-induction of general anaesthesia, Immediately post-Gnana device insertion, 5 minutes post Gnana device insertion
5. Immediately after Gnana device insertion
6. Immediately, 2 hours and 24 hours after Gnana device removal. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   15/12/2017 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Laryngeal mask airway (LMA) devices are presently use worldwide by anaesthesiologist for airway management in adults and children’s and is considered a novel route to provide general anaesthesia. There are currently seven versions of the LMA’s available, which are LMA-Classic, LMA-Unique, LMA-Fastrach, LMA-ProSeal, LMA-Supreme, LMA-Ambu and LMA-Soft Seal. Recently, a laryngeal airway device was designed as a latest version of LMA called Gnana laryngeal airway. It consists of an elliptical cuffed mask and an airway tube. The concave portion of the mask when inflated faces the vocal cords. With the aim of keeping the area around the laryngeal mask clean of secretions, an inbuilt small suction port has been added into convex part of the laryngeal mask airway. there are numerous clinical studies involving the use of various version of LMAs, attesting to their safety and performance in various clinical situations. It is hypothesised that the Gnana laryngeal airway might reduce the possible airway complication by incorporation of suction port on its convex surface. At present there are limited trials done on the Gnana laryngeal airway. The purpose of this study is to evaluate Gnana laryngeal airway in terms of success rate, ease and speed of insertion, performance during general anaesthesia (oropharyngeal leak pressure (OLP) measurement after insertion of device by documented method and exact placement of device seen by flexible fiberoptic view of larynx) and rate of complications in patients requiring anaesthesia for various surgical procedures.  
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