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CTRI Number  CTRI/2019/04/018843 [Registered on: 30/04/2019] Trial Registered Prospectively
Last Modified On: 29/04/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A research to evaluate and compare two airway management devices (Baska airway and Proseal laryngeal mask airway)in patients undergoing general surgery. 
Scientific Title of Study   Comparison of ventilatory efficacy and airway dynamics between self pressurizing (Baska airway) and non-self pressurizing (Proseal laryngeal mask airway) supraglottic airways in adult patients scheduled for surgeries during general anaesthesia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Maninder kaur 
Designation  Post Graduate Junior Resident 
Affiliation  Dept. of Anaesthesia and Intensive Care, GMCH-32 ,Chandigarh 
Address  Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, sector-32, Chandigarh.

Chandigarh
CHANDIGARH
160031
India 
Phone  9780462029  
Fax    
Email  mkmaninder30@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manpreet Singh 
Designation  Associate Professor 
Affiliation  Government medical college and hospital , Chandigarh 
Address  Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, sector-32, Chandigarh.

Chandigarh
CHANDIGARH
160031
India 
Phone  9646121503  
Fax    
Email  manpreetdawar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Maninder kaur 
Designation  Post Graduate Junior Resident 
Affiliation  Dept. of Anaesthesia and Intensive Care, GMCH-32 ,Chandigarh 
Address  Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, sector-32, Chandigarh.

Chandigarh
CHANDIGARH
160031
India 
Phone  9780462029  
Fax    
Email  mkmaninder30@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesia and Intensive Care, Government Medical College and Hospital, sector-32, Chandigarh. 
 
Primary Sponsor  
Name  Government Medical College and Hospital 
Address  Department of Anaesthesia and Intensive Care, D-block, fifth floor, Government Medical College and Hospital, sector-32, Chandigarh. 
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 Maninder Kaur  Governmen Medical College and Hospital, Chandigarh  Department of Anaesthesia and Intensive Care, D-block, fifth floor, Government Medical College and Hospital sector 32 Chandigarh.
Chandigarh
CHANDIGARH 		 9780462029

mkmaninder30@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Baska airway  Will be used to maintain the patency of airway during general anaesthesia. The device will only be inserted after induction of anaesthesia. 
Intervention  Proseal laryngeal mask airway  Will be used to maintain the patency of airway during general anaesthesia. The device will only be inserted after induction of anaesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The following patients would be included for the study:
1. Age group between 18 to 60 years
2. American Society of Anaesthesiologist (ASA) physical status I and II
3. Patients scheduled for elective surgery under general anaesthesia (Duration of surgery 2 ±0.5 hrs) 
 
ExclusionCriteria 
Details  The following patients would not be included for the study:
1. Patients with anticipated difficult airway (ADS >8).
2. Patients with upper respiratory tract infection
3. Patients with increased risk of regurgitation and aspiration of gastric content.
4. Patients with a body mass index (BMI) > 35 kg.m2
5. Patients with history of radiotherapy to the neck involving the hypopharynx.
6. Patients undergoing surgeries involving neck and oral cavity.
7. Pregnant patients. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare respiratory indexes in both Baska airway and Proseal laryngeal mask airway.  Immediatly after the placement of device then every 5 mins till 15 mins and then at 30 mins after the placement of device. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare ease of insertion, oropharyngeal leak pressure, hemodynamic data and postoperative complications in two groups.  1. Ease of insertion of device, ease of use of gastric tube placement and fiberoptic placement will be observed immediatly after the placement of device.
2. Hemodynamic and ventilatory parameters every 5 mins till 15 mins and then at 30 mins after the placement of device. 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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 4 
Date of First Enrollment (India)   01/05/2019 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is a prospective, randomised, parallel group, active control trial where two devices Baska airway and Proseal laryngel mask airway, used for maintainence of airway during general anaesthesia , will be compared primarily in terms of differences in there respiratory indexes. Secondary outcome measured will compare the ease of insertion of two LMA’s, oropharyngeal leak pressure, hemodynamic parameters and post operative complications, in patients undergoing surgery under general anaesthesia. 
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