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CTRI Number  CTRI/2025/01/079725 [Registered on: 29/01/2025] Trial Registered Prospectively
Last Modified On: 29/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of oropharyngeal leak pressure using i-Gel in blind technique vs video laryngoscope technique in paediatric patients undergoing Laparoscopic surgeries 
Scientific Title of Study   Comparison of Oropharyngeal Leak Pressure using i-Gel in Blind Technique Versuss Video Laryngoscope in Paediatric Patients undergoing Laparoscopic Surgeries: A Randomised Control Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SRIRAM 
Designation  Post graduate Resident 
Affiliation  Armed Forces Medical College 
Address  Dept of Anaesthesia and Critical Care, Armed Forces Medical College, Wanowrie, Pune

Pune
MAHARASHTRA
411040
India 
Phone  9600245285  
Fax    
Email  ramsri89@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Saajan Joshi 
Designation  Professor 
Affiliation  Army Institute of Cardio thoracic Sciences 
Address  Dept of Anaesthesia and Critical Care, Cardiothoracic centre, Wanowrie, Pune.
Dept of Anaesthesia and Critical Care, Cardiothoracic centre, Wanowrie, Pune.
Pune
MAHARASHTRA
411040
India 
Phone  9599699348  
Fax    
Email  joe21sf@gmail.com  
 
Details of Contact Person
Public Query
 
Name  SRIRAM 
Designation  Post graduate Resident 
Affiliation  Armed Forces Medical College 
Address  Dept of Anaesthesia and Critical Care, Armed Forces Medical College, Wanowrie, Pune

Pune
MAHARASHTRA
411040
India 
Phone  9600245285  
Fax    
Email  ramsri89@gmail.com  
 
Source of Monetary or Material Support  
Armed Forces Medical College, Solapur-Pune Hwy, Wanowrie, Pune, Maharashtra - 411010 
 
Primary Sponsor  
Name  Armed Forces Medical College 
Address  Armed Forces Medical College, Solapur-Pune Highway, Wanowrie, Pune, Maharashtra - 411040 
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 
Dr Sriram S  Command Hospital - Southern Command, Pune  OT Complex - Block-5, floor-5, Department of Anaesthesiology
Pune
MAHARASHTRA 
9600245285

ramsri89@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethical Commitee, Armed Forces Medical College  Approved 
Institutional Ethical Commitee, Armed Forces Medical College  Approved 
Institutional Ethical Commitee, Armed Forces Medical College  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  Blind insertion of I-Gel  In the Comparator group i-Gel is placed blindly for ventilation. 
Intervention  Video laryngoscope assisted iGel placement  In the intervention group i-Gel Supraglottic airway is placed using a Video laryngoscope during intubation process for confirmation of position of the i-Gel 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1. Pediatric patients within a defined age range, typically from 1 year to 10 years old.
2. ASA I and II.
 
 
ExclusionCriteria 
Details  1. Suspected difficult airway.
2. Previous abdominal surgeries.
3. Any comorbidities that would affect time under
anesthesia, intragastric pressure and abdominal
pressure.
4. Weight of less than 5 kg.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare oropharyngeal leak pressure using i-Gel in blind technique vs video laryngoscope assisted placement.  03 Minutes after i-Gel placement 
 
Secondary Outcome  
Outcome  TimePoints 
1. Peak pressure before and
after pneumoperitoneum
2. Number of attempts
3. Insertion time
 
Intraoperative 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2 
Date of First Enrollment (India)   10/02/2025 
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  

1. The second-generation supraglottic airway (SGA) devices have revolutionized airway management in patients scheduled for surgery under general anaesthesia (GA). Each device possesses some unique features and has been used extensively in paediatric patients with varying degrees of success. The blind insertion technique is routinely used to insert the second generation supraglottic devices. Radiological studies have shown that incidence of malposition after blind insertion of LMA may range up to 50-80%. A study in paediatric patients undergoing magnetic resonance imaging found that radiologically proven malposition of LMA-unique was seen in 42.9% of children, though the clinical performance of LMA-unique was not hampered.

The advancement in anaesthesia practice is towards performing procedures under the vision and includes ultrasound assistance for regional blocks, ultrasound-guided central venous cannulation, fiberoptic/VL guided endotracheal intubation etc. Anaesthesiologists almost confirm the correct position of the ETT and corrective measures are immediately taken in the context of misplaced ETT but often accept sub optimally placed SGAs .

The Difficult Airway Society and the ASA difficult airway guidelines recommend blind airway management unreliable and Video laryngoscopy (VL) has become an integral part of airway management. VL offers better glottis visualization on the screen and enables correct placement of SGA beneath the glottis, thereby preventing epiglottic down folding or distal cuff displacement and improving functional or anatomical optimization of SGA .

Oropharyngeal leak pressure (OLP) refers to the airway leak or pressure airway sealing, and it is the most significant index for evaluating the security and effectiveness of airway tools . To quantify the effectiveness of airway sealing and protecting airway in tools, oropharyngeal leak pressure (OLP) is adopted . Under vision placement of SGA has reported a higher OPLP compared to blind insertion in adults.

Therefore, we planned a study to compare the video laryngoscope guided i-Gel insertion with that of the blind insertion technique in paediatric patients undergoing laparoscopic surgeries with regard to oropharyngeal leak pressure. We hypothesized that there would be no difference in the oropharyngeal leak pressure between the video laryngoscope guided and blind insertion technique of i-Gel in paediatric patients. The primary objective of the study was to compare the oropharyngeal leak pressure between blind and video laryngoscope guided insertion. Simultaneously, the insertion characteristics such as the number of attempts and the time required for successful insertion and the OPLP before and after pneumoperitoneum were also compared between two insertion techniques of IGEL in paediatric population.

 
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