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CTRI Number  CTRI/2024/04/066201 [Registered on: 24/04/2024] Trial Registered Prospectively
Last Modified On: 23/04/2024
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   Comparison of new generation Baska mask with I-gel in elective surgery under general anaesthesia in terms of difference in oropharyngeal seal pressure, ease of insertion, leak fraction and hemodynamic changes. 
Scientific Title of Study   Comparison of new generation Baska mask with I-gel in elective surgery under general anaesthesia: A prospective randomized controlled trial. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhishek Joshi 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, Gorakhpur 
Address  Dept. of Anaesthesiology, All India Institute of Medical Sciences, Kunraghat, Gorakhpur, Uttar Pradesh - 273008

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  8077642267  
Fax    
Email  doc.abhishekjoshi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Priyanka Dwivedi 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Gorakhpur 
Address  Dept. of Anaesthesiology, All India Institute of Medical Sciences, Kunraghat, Gorakhpur, Uttar Pradesh - 273008

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  8795453444  
Fax    
Email  drpriyad1111@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhishek Joshi 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences Gorakhpur 
Address  Dept. of Anaesthesiology, All India Institute of Medical Sciences, Kunraghat, Gorakhpur, Uttar Pradesh - 273008

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  8077642267  
Fax    
Email  doc.abhishekjoshi@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Gorakhpur, Kunraghat, Gorakhpur, Uttar Pradesh, India - 273008 
 
Primary Sponsor  
Name  Dr Abhishek Joshi 
Address  Dept. of Anaesthesiology, All India Institute of Medical Sciences, Kunraghat, Gorakhpur, Uttar Pradesh, India - 273008 
Type of Sponsor  Other [Self] 
 
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 Abhishek Joshi  All India Institute of Medical Sciences, Gorakhpur  Major OT complex, Department of Anaesthesia
Gorakhpur
UTTAR PRADESH 		 8077642267

doc.abhishekjoshi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee, AIIMS, Gorakhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z469||Encounter for fitting and adjustment of unspecified device, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group BM   Group BM – Patient’s airway will be secured with Baska mask. Duration: Till the completion of the surgery.  
Intervention  Group IG  Group IG- Patient’s airway will be secured with I-gel. Duration: Till the completion of the surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient belonging to American Society of Anaesthesiologists physical status (ASA) I and II, who are scheduled for routine surgeries under general anaesthesia. 
 
ExclusionCriteria 
Details  1. Patient’s refusal,
2. Mouth opening of less than 3 fingers or with difficult airway,
3. Body mass index (BMI) more than 35 Kg/m2,
4. Patients with neck pathology
5. Pregnant females,
6. Patients at increased risk of gastric aspiration.
7. Laparoscopic surgery
8. Emergency surgery 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare oropharyngeal seal pressure (OLP) while using I-Gel and Baska mask at various time intervals   To compare oropharyngeal seal pressure (OLP) while using I-Gel and Baska mask at various time intervals for 30 minutus 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the ease of insertion of each device in terms of time taken and number of attempts per device insertion.
To compare leak fraction by using either I-Gel or Baska mask.
To compare the hemodynamic changes using either device at various time intervals
Any post-operative complications like hoarseness, sore throat or dysphagia.  		 Immediately after insertion and every 5 minutes till 30 minutes 
 
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   Phase 4 
Date of First Enrollment (India)   04/05/2024 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is a prospective randomized controlled trial comparing the I-Gel and Baska mask regarding the quality of ventilation and ease of insertion in 80 patients undergoing routine surgeries admitted at AIIMS Gorakhpur. The primary outcome measures will be to compare Oropharyngeal seal pressure(OLP) while using I-Gel and Baska mask at various time intervals. Secondary outcomes are to compare the ease of insertion, leak fraction, intra-operative hemodynamic changes and any post-operative complications, hoarseness, sore throat or dysphagia while using either device at various time intervals. Safety outcome will be recording and reporting of adverse events. 
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